A Phase 3 interventional study of Pregabalin and placebo in Pain, Postoperative and Hernia, Inguinal, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.. Completed at 42 sites in 6 countries. Open to male participants aged 17 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-01-25.
Sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Phase 3, Interventional, and Treatment
The purpose of this study is to test whether pregabalin added to the standard of care with dosing starting preoperatively and continuing for 1 week post surgery will decrease the intensity of acute post-operative pain following inguinal hernia repair.
1,096 studies on the registry are indexed under Hernia; 132 are open to participants now.
This study's enrollment of 425 is above the median of 80 across 739 interventional studies indexed under Hernia.
Browse Hernia studies →Pfizer's Upjohn has merged with Mylan to form Viatris Inc. is the lead sponsor of 431 studies on the registry; none are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 8 (89%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Pregabalin
Drug: placebo
Drug: Pregabalin
Drug: Pregabalin
150 mg BID
Placebo
75 mg BID
25 mg BID
Modified Brief Pain Inventory-Short Form (mBPI-sf): Worst Pain 24 Hours Post Surgery
m-BPI-sf: a self-administered 11-point Likert rating scale to rate pain in the past 24 hours. A single item pertains to worst pain in the past 24 hours: range of 0 (no pain) to 10 (worst imaginable pain).
Time frame: 24 hours post surgery
Numeric Rating Scale (NRS): Current Pain With Movement - Sitting
NRS: a self-administered questionnaire to rate pain. A single item asks to rate pain with movement caused by sitting (sitting in a standardized fashion after being in a fully supine position); range: 0 (no pain) to 10 (worst pain).
Time frame: Baseline; 2 hours (h) before surgery (BS); 1, 2, and 3 h post surgery (PS); Days 2, 3, 4, 5, 6, and 7 PS; and End of Treatment (EOT [Day 7 PS or Early Termination])
Numeric Rating Scale (NRS): Current Pain With Movement - Walking
NRS: a self-administered questionnaire to rate pain. A single item asks to rate pain with movement caused by walking (rising from sitting position and walking approximately 5 meters or 16 feet at a moderate pace); range: 0 (no pain) to 10 (worst pain).
Time frame: Baseline; 2 hours (h) before surgery (BS); 1, 2, and 3 h post surgery (PS); Days 2, 3, 4, 5, 6, and 7 PS; and End of Treatment (EOT [Day 7 PS or Early Termination])
Numeric Rating Scale (NRS): Current Pain With Movement - Coughing
NRS: a self-administered questionnaire to rate pain. A single item asks to rate pain with movement caused by coughing (coughing two times while sitting); range: 0 (no pain) to 10 (worst pain)
Time frame: Baseline; 2 hours (h) before surgery (BS); 1, 2, and 3 h post surgery (PS); Days 2, 3, 4, 5, 6, and 7 PS; and End of Treatment (EOT [Day 7 PS or Early Termination])
Numeric Rating Scale (NRS): Current Pain With Movement - Area Under the Curve (AUC) for Sitting, Walking, and Coughing
NRS: a self-administered questionnaire to rate pain. AUC from 1 h PS through 48 h PS for ratings of pain caused by movements of sitting, walking, and coughing; Range: 0 (no pain) to 10 (worst pain).
Time frame: 1 hour through 48 hours post surgery
Numerical Rating Scale (NRS): Current Pain at Rest
NRS: a self-administered questionnaire to rate pain. A single item asks participant to rate current pain at rest (preceding pain with movement); range: 0 (no pain) to 10 (worst pain).
Time frame: 2 hours (h) before surgery (BS); 1, 2, and 3 h post surgery (PS); Days 2, 3, 4, 5, 6, 7, 8, 9, and 10 PS
Numeric Rating Scale (NRS): Current Pain at Rest - Area Under the Curve (AUC)
NRS: a self-administered questionnaire to rate pain. AUC for a single item asking participant to rate current pain at rest (preceding pain with movement); range: 0 (no pain) to 10 (worst pain).
Time frame: 1 through 48 hours post surgery (PS)
Numeric Rating Scale (NRS): Average Pain
NRS: a self-administered questionnaire to rate pain. A single item asks participant to rate pain on average in the last 24 hours; range: 0 (no pain) to 10 (worst pain).
Time frame: 2 hours (h) before surgery (BS); 1, 2, and 3 h post surgery (PS); Days 1, 2, 3, 4, 5, 6, and 7 PS
Time From End of Surgery to First Rescue Medication
Rescue medication includes both naproxen and narcotic medication (including tramadol and opioid analgesics). For subjects without use of rescue medication, the time-to-event variable is censored at the Beginning of Taper Visit (Day 7 PS) or at time of withdrawal.
Time frame: Day 1 through Day 7 post surgery
Time From End of Surgery to Reach a Total Score of at Least 9 on the Post-Anesthetic Discharge Scoring System (PADS)
PADS is a 5-item scale (individual item range: 0-2; higher scores indicating better readiness for hospital discharge). Total score range: 0-10, with 9 or higher indicating eligibility for discharge. End of surgery is time of transfer to post-anesthesia care unit (PACU). Subjects who did not reach a score of 9 on PADS were censored at the date and time of discharge.
Time frame: Day 1
Time From End of Surgery to Discharge From Post-Anesthesia Care Unit (PACU)
Time frame: Day 1
Daily Sleep Interference Rating Scale (DSIRS) Score
DSIRS: self-administered 11-point Likert scale ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep \[unable to sleep due to pain\]) during past 24-hour period. Higher score indicates a greater level of sleep disturbance. Performed daily on awakening, prior to taking study medication.
Time frame: Days 2, 3, 4, 5, 6, 7, 8, 9, and 10 post surgery (PS)
Total Cumulative Dose of Opioids and Tramadol Used During and After Surgery
Total cumulative dose of opioids and tramadol administered by any route during surgery and postoperatively. Dose of tramadol calculated as milligrams (mg) of oral morphine equivalent.
Time frame: 24, 48, and 72 hours (h) post surgery (PS), and Days 4, 5, 6, and 7 PS
Amount of Non-opioid Rescue Medication (Naproxen and Antiemetic Medications) Used During the Study
Total cumulative dose of naproxen calculated in milligrams (mg) from the end of surgery up to and including Day 7 after surgery.
Time frame: End of Surgery through Day 7 post surgery
Total Clinically Meaningful Event (CME) Score and Cumulative Total Distinct CME Score Using the Opioid-Related Symptom Distress Scale (OR-SDS)
OR-SDS: a self-administered assessment of 10 common opioid-related side effects (symptoms). A CME is a severe or very severe symptom (or moderate or greater severity symptom of confusion). The Total Distinct CME score is the sum of CMEs across symptoms (range: 0 \[none\] to 10 \[10 CMEs\]); the Cumulative Total Distinct (CT Distinct) CME score is the sum of Total Distinct CME scores at observation and prior observations. The Total CME score is the same as the Total Distinct CME score except that only 1 CME is counted if both nausea and vomiting (or retching) occur (range: 0 \[none\] to 9 \[9 CMEs\]).
Time frame: 3, 24, and 72 hours (h) Post-Surgery (PS), and End of Treatment (EOT [Day 7 PS or Early Termination])
Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS)
OR-SDS: a self-administered assessment of 10 common opioid-related side effects (symptoms). A CME is a severe or very severe symptom (or moderate or greater severity symptom of confusion). For individual symptom categories, the number of subjects who experienced at least one CME. Concentrate (concentr).
Time frame: 3, 24, and 72 hours (h) post surgery (PS), and End of Treatment (EOT [Day 7 PS or Early Termination])
Subject Global Evaluation of Study Medication (GESM)
GESM is a self-administered overall impression (global evaluation) of study medication received for pain; 4 categories: poor, fair, good, and excellent.
Time frame: 24 hours (h) post surgery (PS) and End of Treatment (EOT [Day 7 PS or Early Termination])
Participants With Wound Healing Complications
Investigator-assigned mutually exclusive categories of: 1) no surgical wound complication, 2) superficial incisional surgical site infection, 3) deep incisional surgical site infection, 4) organ or space surgical site infection, or 5) non-infectious wound healing complication.
Time frame: Day 7 post surgery (PS) and up to 30 days PS
Participants With Physician Contacts Post-discharge
Number of participants who answered "yes" to the Post-Surgery Contact question: "From the time you were discharged from the hospital, did you have to contact any type of physician because of pain, difficulty getting up and walking about, or difficulty with passing urine?"
Time frame: 24 and 72 hours (h) post surgery (PS)
Baseline and Change From Baseline in Anxiety Visual Analog Scale (VAS) Score
Anxiety VAS is a single-item self-administered continuous measure of anxiety using a 100-millimeter (mm) line on which the subject is asked to place a mark indicating the intensity of current anxiety. The score is the distance in mm from the left-most point on the line to the subject's mark; range: 0 (Not at all anxious) at the left-most point to 100 (Extremely anxious) at the right-most point. Performed prior to blood draws.
Time frame: Baseline; 2 hours (h) before surgery (BS); 1, 2, and 3 h PS; Days 2, 3, 4, 5, 6, 7, 8, and 9 PS
Baseline and Change From Baseline in EuroQol (EQ-5D) Health State Profile Score
EQ-5D is a self-administered questionnaire to assess health-related quality of life in 5 domains (mobility, self care, usual activities, pain or discomfort, and anxiety or depression). Scores from the 5 domains are used to calculate a single index value: the Health State Profile Score; range: 0.0 (death) to 1.0 (perfect health), higher scores indicating better health state.
Time frame: Baseline and End of Treatment (EOT [Day 7 post surgery or Early Termination])
Change From Baseline in Pain Catastrophizing Scale (PCS) Total Score and Subscales
The PCS is a self-administered questionnaire with 13 items, each scored from 0 (not at all) to 4 (all the time) for extent to which participant catastrophizes postoperative pain. Total score is sum of scores for all questions (range: 0 to 52); Subscale scores: Rumination (sum of scores for 4 items; range: 0 to 16); Magnification (sum of scores for 3 items; range: 0 to 12); and Helplessness (sum of scores for 6 items; range: 0 to 24); higher scores mean a greater extent of pain catastrophizing.
Time frame: 3 hours (h) post surgery (PS) and End of Treatment (EOT [Day 7 PS or Early Termination])
Relationship Between Baseline and Postoperative Pain Catastrophizing Scale (PCS) Score and Severity of Acute Pain and to Response to Therapy
The PCS is a self-administered questionnaire with 13 items, each scored from 0 (not at all) to 4 (all the time) for extent to which participant catastrophizes postoperative pain. Total score is sum of scores for all items (range: 0 to 52); higher scores mean a greater extent of pain catastrophizing.
Time frame: Baseline and Days 1 and 7 post surgery (PS)
Baseline and Change From Baseline in Short Form Acute Health Survey 12-Item Version (SF-12v2) Physical Component Summary Score (PCSS) and Mental Component Summary Score (MCSS)
PCSS and MCSS are component summary scores from the self-administered SF-12v2 acute health quality of life, norm-based survey. PCSS range: 4.95 to 76.13; MCSS range: -0.79 to 79.69; lowest scores mean very much below and highest scores mean very much above the general population average.
Time frame: Baseline and End of Treatment (EOT [Day 7 post surgery or Early Termination])
Participants With Chronic Postoperative Pain
Number of participants who reported surgery-related pain at assessment (by answering 'yes' to a single question: "In the last 24 hours, have you had pain in the area affected by your surgery?")
Time frame: 1, 3, and 6 months (mo) post surgery (PS)
Chronic Postoperative Pain: Pain Severity Index Score and Pain Interference Index Score on the Modified Brief Pain Inventory-Short Form (mBPI-sf)
m-BPI-sf: a self-administered 11-point Likert rating scale to rate pain in the past 24 hours. Pain interference index score is mean of 7 individual item scores for interference of pain with functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life); range: 0 (does not interfere) to 10 (completely interferes with functional activities). Pain severity index score is mean of 4 individual item scores for pain severity (pain right now, and worst, least, and average pain); range: 0 (no pain) to 10 (worst imaginable pain).
Time frame: 1, 3, and 6 months (mo) post surgery (PS)
Chronic Postoperative Pain: Total Score and Subscale Scores Using the Neuropathic Pain Symptom Inventory (NPSI)
NPSI: a 12-item self-administered questionnaire to assess the characteristics of neuropathic pain on average in the last 24 hours. 5 subscale scores include: burning spontaneous (spont.) pain, pressing spont. pain, paroxysmal pain, evoked pain, and paresthesia or dysesthesia (paresth/dysesth) (range: 0 \[no pain\] to 10 \[worst pain imaginable\]); total score calculated from the 5 pain subscores (range: 0 to 0.5), higher scores meaning worse pain.
Time frame: 1, 3, and 6 months (mo) post surgery (PS)
Male subjects were enrolled at 34 centers and participated in the study between 18 January 2008 and 14 September 2009.
| Milestone | Pregabalin 50 mg | Pregabalin 150 mg | Pregabalin 300 mg | Placebo |
|---|---|---|---|---|
| Started | 108 | 106 | 103 | 108 |
| Completed | 103 | 104 | 98 | 103 |
| Not completed | 5 | 2 | 5 | 5 |
| Withdrew: Adverse event | 1 | 0 | 1 | 1 |
| Withdrew: Lost to follow-up | 0 | 0 | 0 | 1 |
| Withdrew: Other | 3 | 2 | 1 | 2 |
| Withdrew: Withdrawal by subject | 1 | 0 | 3 | 1 |
m-BPI-sf: a self-administered 11-point Likert rating scale to rate pain in the past 24 hours. A single item pertains to worst pain in the past 24 hours: range of 0 (no pain) to 10 (worst imaginable pain).
| scores on scale | Pregabalin 50 mg | Pregabalin 150 mg | Pregabalin 300 mg | Placebo |
|---|---|---|---|---|
| Modified Brief Pain Inventory-Short Form (mBPI-sf): Worst Pain 24 Hours Post Surgery | 5.2 ± 0.24 | 5.4 ± 0.25 | 4.7 ± 0.24 | 5.4 ± 0.24 |
NRS: a self-administered questionnaire to rate pain. A single item asks to rate pain with movement caused by sitting (sitting in a standardized fashion after being in a fully supine position); range: 0 (no pain) to 10 (worst pain).
| scores on scale | Pregabalin 50 mg | Pregabalin 150 mg | Pregabalin 300 mg | Placebo |
|---|---|---|---|---|
| Baseline | 1.3 ± 0.17 | 1.2 ± 0.18 | 1.0 ± 0.17 | 1.1 ± 0.17 |
| 2 h BS (n=102, 99, 101, 101) | 0.7 ± 0.10 | 0.6 ± 0.10 | 0.8 ± 0.10 | 0.9 ± 0.10 |
| 1 h PS (n=92, 91, 91, 91) | 3.6 ± 0.24 | 4.1 ± 0.24 | 3.1 ± 0.24 | 4.1 ± 0.24 |
| 2 h PS (n=96, 93, 100, 96) | 3.3 ± 0.21 | 3.7 ± 0.21 | 3.2 ± 0.20 | 3.5 ± 0.21 |
| 3 h PS (n=100, 98, 101, 101) | 2.7 ± 0.19 | 3.3 ± 0.19 | 2.9 ± 0.18 | 3.1 ± 0.19 |
| Day 2 PS (n=102, 98, 101, 100) | 3.5 ± 0.22 | 3.6 ± 0.23 | 3.4 ± 0.22 | 3.7 ± 0.22 |
| Day 3 PS (n=102, 98, 100, 101) | 2.7 ± 0.22 | 3.0 ± 0.22 | 3.0 ± 0.22 | 2.8 ± 0.22 |
| Day 4 PS (n=101, 99, 99, 101) | 2.2 ± 0.20 | 2.2 ± 0.20 | 2.4 ± 0.20 | 2.3 ± 0.20 |
| Day 5 PS (n=101, 99, 98, 100) | 1.7 ± 0.18 | 1.8 ± 0.18 | 1.9 ± 0.18 | 2.0 ± 0.18 |
| Day 6 PS (n=100, 99, 98, 99) | 1.6 ± 0.17 | 1.6 ± 0.17 | 1.8 ± 0.17 | 1.7 ± 0.17 |
| Day 7 PS (n=96, 93, 91, 93) | 1.5 ± 0.17 | 1.5 ± 0.17 | 1.8 ± 0.18 | 1.5 ± 0.17 |
| EOT (n=101, 99, 100, 100) | 1.0 ± 0.15 | 1.3 ± 0.15 | 1.3 ± 0.15 | 1.2 ± 0.15 |
NRS: a self-administered questionnaire to rate pain. A single item asks to rate pain with movement caused by walking (rising from sitting position and walking approximately 5 meters or 16 feet at a moderate pace); range: 0 (no pain) to 10 (worst pain).
| scores on scale | Pregabalin 50 mg | Pregabalin 150 mg | Pregabalin 300 mg | Placebo |
|---|---|---|---|---|
| Baseline | 1.9 ± 0.23 | 1.6 ± 0.24 | 1.9 ± 0.23 | 2.0 ± 0.23 |
| 2 h BS (n=102, 98, 101, 101) | 1.2 ± 0.12 | 1.1 ± 0.12 | 1.2 ± 0.12 | 1.2 ± 0.12 |
| 1 h PS (n=69, 62, 63, 60) | 3.2 ± 0.29 | 3.9 ± 0.32 | 2.9 ± 0.31 | 3.7 ± 0.32 |
| 2 h PS (n=84, 76, 84, 80) | 3.3 ± 0.27 | 3.4 ± 0.28 | 3.1 ± 0.25 | 3.6 ± 0.27 |
| 3 h PS (n=96, 91, 93, 94) | 3.1 ± 0.22 | 3.6 ± 0.23 | 3.0 ± 0.22 | 3.3 ± 0.23 |
| Day 2 PS (n=102, 98, 101, 100) | 3.3 ± 0.23 | 3.8 ± 0.23 | 3.3 ± 0.23 | 3.9 ± 0.23 |
| Day 3 PS (n=102, 98, 100, 101) | 2.7 ± 0.21 | 3.0 ± 0.22 | 2.8 ± 0.21 | 2.9 ± 0.21 |
| Day 4 PS (n=101, 99, 99, 101) | 2.2 ± 0.20 | 2.2 ± 0.20 | 2.1 ± 0.20 | 2.2 ± 0.20 |
| Day 5 PS (n=101, 99, 98, 100) | 1.7 ± 0.17 | 1.8 ± 0.17 | 1.8 ± 0.17 | 1.9 ± 0.17 |
| Day 6 PS (n=100, 99, 98, 99) | 1.5 ± 0.17 | 1.6 ± 0.17 | 1.7 ± 0.17 | 1.6 ± 0.17 |
| Day 7 PS (n=96, 93, 91, 93) | 1.3 ± 0.17 | 1.4 ± 0.17 | 1.5 ± 0.17 | 1.3 ± 0.17 |
| EOT (n=101, 99, 100, 100) | 1.1 ± 0.16 | 1.2 ± 0.16 | 1.3 ± 0.16 | 1.2 ± 0.16 |
NRS: a self-administered questionnaire to rate pain. A single item asks to rate pain with movement caused by coughing (coughing two times while sitting); range: 0 (no pain) to 10 (worst pain)
| scores on scale | Pregabalin 50 mg | Pregabalin 150 mg | Pregabalin 300 mg | Placebo |
|---|---|---|---|---|
| Baseline | 2.4 ± 0.25 | 1.8 ± 0.26 | 2.2 ± 0.26 | 2.1 ± 0.26 |
| 2 h BS (n=102, 99, 101, 101) | 1.4 ± 0.15 | 1.5 ± 0.15 | 1.6 ± 0.15 | 1.8 ± 0.15 |
| 1 h PS (n=95, 91, 93, 90) | 4.4 ± 0.26 | 4.8 ± 0.26 | 3.7 ± 0.26 | 4.6 ± 0.26 |
| 2 h PS (n=96, 93, 99, 97) | 4.1 ± 0.23 | 4.3 ± 0.24 | 3.8 ± 0.23 | 4.3 ± 0.23 |
| 3 h PS (n=100, 99, 100, 100) | 3.8 ± 0.22 | 4.1 ± 0.22 | 3.8 ± 0.22 | 3.9 ± 0.22 |
| Day 2 PS (n=102, 98, 101, 100) | 4.6 ± 0.25 | 5.1 ± 0.26 | 4.5 ± 0.25 | 5.2 ± 0.25 |
| Day 3 PS (n=102, 98, 101, 100) | 4.3 ± 0.24 | 4.5 ± 0.25 | 4.3 ± 0.25 | 4.5 ± 0.24 |
| Day 4 PS (n=101, 99, 99, 101) | 3.6 ± 0.25 | 3.6 ± 0.25 | 3.6 ± 0.25 | 3.9 ± 0.25 |
| Day 5 PS (n=101, 99, 98, 100) | 2.8 ± 0.24 | 3.1 ± 0.24 | 3.2 ± 0.24 | 3.8 ± 0.24 |
| Day 6 PS (n=100, 99, 98, 99) | 2.6 ± 0.23 | 2.8 ± 0.23 | 2.9 ± 0.23 | 3.2 ± 0.23 |
| Day 7 PS (n=96, 93, 91, 93) | 2.4 ± 0.23 | 2.5 ± 0.24 | 2.5 ± 0.24 | 2.7 ± 0.23 |
| EOT (n=101, 99, 100, 100) | 1.9 ± 0.21 | 2.0 ± 0.21 | 2.3 ± 0.21 | 2.3 ± 0.21 |
NRS: a self-administered questionnaire to rate pain. AUC from 1 h PS through 48 h PS for ratings of pain caused by movements of sitting, walking, and coughing; Range: 0 (no pain) to 10 (worst pain).
| scores on scale | Pregabalin 50 mg | Pregabalin 150 mg | Pregabalin 300 mg | Placebo |
|---|---|---|---|---|
| Sitting (n=100, 99, 101, 101) | 146.22 ± 8.185 | 158.90 ± 8.261 | 148.25 ± 8.115 | 155.57 ± 8.125 |
| Walking (n=97, 91, 95, 96) | 143.82 ± 8.981 | 162.70 ± 9.575 | 143.40 ± 9.063 | 161.74 ± 9.235 |
| Coughing (n=101, 99, 100, 101) | 202.93 ± 9.635 | 219.69 ± 9.778 | 199.13 ± 9.645 | 220.34 ± 9.601 |
NRS: a self-administered questionnaire to rate pain. A single item asks participant to rate current pain at rest (preceding pain with movement); range: 0 (no pain) to 10 (worst pain).
| scores on scale | Pregabalin 50 mg | Pregabalin 150 mg | Pregabalin 300 mg | Placebo |
|---|---|---|---|---|
| 2 h BS (n=102, 99, 101, 101) | 0.9 ± 0.11 | 0.7 ± 0.12 | 0.8 ± 0.11 | 0.7 ± 0.11 |
| 1 h PS (n=102, 97, 100, 100) | 3.3 ± 0.20 | 3.7 ± 0.20 | 2.9 ± 0.20 | 3.8 ± 0.20 |
| 2 h PS (n=102, 99, 101, 101) | 3.1 ± 0.18 | 3.2 ± 0.18 | 2.7 ± 0.18 | 3.0 ± 0.18 |
| 3 h PS (n=102, 99, 101, 101) | 2.5 ± 0.17 | 2.7 ± 0.18 | 2.6 ± 0.17 | 2.7 ± 0.17 |
| Day 2 PS (n=101, 99, 100, 101) | 3.2 ± 0.22 | 3.3 ± 0.23 | 3.3 ± 0.22 | 3.3 ± 0.22 |
| Day 3 PS (n=102, 99, 100, 100) | 2.5 ± 0.19 | 2.7 ± 0.19 | 2.2 ± 0.19 | 2.3 ± 0.19 |
| Day 4 PS (n=101, 99, 99, 101) | 2.0 ± 0.18 | 2.0 ± 0.18 | 1.9 ± 0.18 | 1.8 ± 0.18 |
| Day 5 PS (n=101, 98, 98, 100) | 1.4 ± 0.17 | 1.8 ± 0.17 | 1.8 ± 0.17 | 1.7 ± 0.17 |
| Day 6 PS (n=100, 99, 98, 98) | 1.3 ± 0.15 | 1.4 ± 0.15 | 1.4 ± 0.15 | 1.5 ± 0.15 |
| Day 7 PS (n=96, 93, 90, 93) | 1.2 ± 0.14 | 1.4 ± 0.14 | 1.3 ± 0.14 | 1.3 ± 0.14 |
| Day 8 PS (n=60, 62, 53, 60) | 1.3 ± 0.19 | 1.2 ± 0.19 | 1.2 ± 0.20 | 1.1 ± 0.19 |
| Day 9 PS (n=21, 24, 25, 22) | 0.4 ± 0.21 | 1.0 ± 0.20 | 0.6 ± 0.20 | 1.5 ± 0.19 |
| Day 10 PS (n=11, 11, 13, 11) | 0.5 ± 0.33 | 1.0 ± 0.33 | 0.9 ± 0.31 | 0.9 ± 0.29 |
NRS: a self-administered questionnaire to rate pain. AUC for a single item asking participant to rate current pain at rest (preceding pain with movement); range: 0 (no pain) to 10 (worst pain).
| score on scale | Pregabalin 50 mg | Pregabalin 150 mg | Pregabalin 300 mg | Placebo |
|---|---|---|---|---|
| Numeric Rating Scale (NRS): Current Pain at Rest - Area Under the Curve (AUC) | 133.8 ± 7.88 | 141.3 ± 7.99 | 132.3 ± 7.78 | 135.1 ± 7.86 |
NRS: a self-administered questionnaire to rate pain. A single item asks participant to rate pain on average in the last 24 hours; range: 0 (no pain) to 10 (worst pain).
| scores on scale | Pregabalin 50 mg | Pregabalin 150 mg | Pregabalin 300 mg | Placebo |
|---|---|---|---|---|
| 2 h BS (n=102, 99, 101, 101) | 1.3 ± 0.15 | 1.3 ± 0.15 | 1.3 ± 0.15 | 1.4 ± 0.15 |
| 1 h PS (n=101, 96, 99, 99) | 2.8 ± 0.19 | 3.0 ± 0.20 | 2.5 ± 0.19 | 3.2 ± 0.19 |
| 2 h PS (n=101, 97, 101, 99) | 3.0 ± 0.18 | 3.2 ± 0.18 | 2.8 ± 0.18 | 3.1 ± 0.18 |
| 3 h PS (n=102, 99, 101, 101) | 2.8 ± 0.17 | 3.2 ± 0.18 | 2.9 ± 0.17 | 3.2 ± 0.17 |
| Day 1 PS (n=101, 99, 101, 99) | 3.4 ± 0.20 | 3.4 ± 0.20 | 2.9 ± 0.20 | 3.4 ± 0.20 |
| Day 2 PS (n=102, 99, 99, 100) | 2.9 ± 0.19 | 3.1 ± 0.19 | 2.9 ± 0.19 | 2.9 ± 0.19 |
| Day 3 PS (n=102, 98, 98 101) | 2.5 ± 0.18 | 2.5 ± 0.18 | 2.4 ± 0.18 | 2.5 ± 0.18 |
| Day 4 PS (n=101, 99, 97, 100) | 1.9 ± 0.17 | 2.0 ± 0.17 | 2.1 ± 0.17 | 1.9 ± 0.17 |
| Day 5 PS (n=101, 99, 98, 100) | 1.6 ± 0.15 | 1.8 ± 0.15 | 1.7 ± 0.15 | 1.8 ± 0.15 |
| Day 6 PS (n=98, 96, 91, 96) | 1.4 ± 0.14 | 1.5 ± 0.14 | 1.7 ± 0.14 | 1.6 ± 0.14 |
| Day 7 PS (n=63, 66, 56, 62) | 1.6 ± 0.19 | 1.5 ± 0.18 | 1.4 ± 0.20 | 1.3 ± 0.19 |
Rescue medication includes both naproxen and narcotic medication (including tramadol and opioid analgesics). For subjects without use of rescue medication, the time-to-event variable is censored at the Beginning of Taper Visit (Day 7 PS) or at time of withdrawal.
No measurements were reported for this outcome.
PADS is a 5-item scale (individual item range: 0-2; higher scores indicating better readiness for hospital discharge). Total score range: 0-10, with 9 or higher indicating eligibility for discharge. End of surgery is time of transfer to post-anesthesia care unit (PACU). Subjects who did not reach a score of 9 on PADS were censored at the date and time of discharge.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
DSIRS: self-administered 11-point Likert scale ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep \[unable to sleep due to pain\]) during past 24-hour period. Higher score indicates a greater level of sleep disturbance. Performed daily on awakening, prior to taking study medication.
| scores on a scale | Pregabalin 50 mg | Pregabalin 150 mg | Pregabalin 300 mg | Placebo |
|---|---|---|---|---|
| Day 2 PS (n=102, 99, 101, 101) | 2.86 ± 0.250 | 2.61 ± 0.255 | 2.17 ± 0.250 | 3.18 ± 0.251 |
| Day 3 PS (n=102, 98, 100, 101) | 2.13 ± 0.211 | 2.01 ± 0.216 | 1.50 ± 0.213 | 2.11 ± 0.212 |
| Day 4 PS (n=101, 99, 99, 101) | 1.52 ± 0.199 | 1.40 ± 0.201 | 1.27 ± 0.200 | 1.48 ± 0.198 |
| Day 5 PS (n=101, 98, 98, 100) | 1.03 ± 0.172 | 1.22 ± 0.174 | 1.09 ± 0.173 | 1.44 ± 0.172 |
| Day 6 PS (n=100, 99, 98, 99) | 0.94 ± 0.147 | 0.98 ± 0.147 | 0.81 ± 0.147 | 1.13 ± 0.147 |
| Day 7 PS (n=98, 96, 92, 96) | 1.04 ± 0.150 | 0.90 ± 0.151 | 0.72 ± 0.154 | 1.00 ± 0.150 |
| Day 8 PS (n=61, 65, 54, 61) | 1.00 ± 0.185 | 0.90 ± 0.180 | 0.59 ± 0.202 | 0.63 ± 0.185 |
| Day 9 PS (n=21, 24, 25, 24) | 0.14 ± 0.240 | 1.01 ± 0.222 | 0.40 ± 0.222 | 1.01 ± 0.212 |
| Day 10 PS (n=11, 11, 13, 11) | 0.15 ± 0.349 | 1.16 ± 0.347 | 0.08 ± 0.332 | 0.72 ± 0.310 |
Total cumulative dose of opioids and tramadol administered by any route during surgery and postoperatively. Dose of tramadol calculated as milligrams (mg) of oral morphine equivalent.
| mg | Pregabalin 50 mg | Pregabalin 150 mg | Pregabalin 300 mg | Placebo |
|---|---|---|---|---|
| 24 h PS (n=102, 99, 101, 101) | 10.29 ± 2.275 | 9.44 ± 2.320 | 6.58 ± 2.279 | 16.03 ± 2.283 |
| 48 h PS (n=102, 99, 101, 101) | 13.15 ± 2.763 | 14.10 ± 2.817 | 9.73 ± 2.768 | 19.79 ± 2.772 |
| 72 h PS (n=102, 99, 101, 101) | 14.59 ± 3.088 | 16.99 ± 3.148 | 12.34 ± 3.092 | 22.20 ± 3.097 |
| Day 4 PS (n=102, 99, 101, 101) | 15.35 ± 3.474 | 18.65 ± 3.542 | 14.18 ± 3.479 | 23.97 ± 3.485 |
| Day 5 PS (n=102, 99, 101, 101) | 16.09 ± 3.786 | 20.46 ± 3.860 | 14.64 ± 3.792 | 25.57 ± 3.798 |
| Day 6 PS (n=101, 99, 99, 100) | 15.99 ± 4.072 | 21.57 ± 4.139 | 15.81 ± 4.105 | 26.90 ± 4.085 |
| Day 7 PS (n=99, 99, 97, 100) | 15.88 ± 4.291 | 22.23 ± 4.322 | 16.16 ± 4.334 | 28.15 ± 4.265 |
Total cumulative dose of naproxen calculated in milligrams (mg) from the end of surgery up to and including Day 7 after surgery.
| mg | Pregabalin 50 mg | Pregabalin 150 mg | Pregabalin 300 mg | Placebo |
|---|---|---|---|---|
| Amount of Non-opioid Rescue Medication (Naproxen and Antiemetic Medications) Used During the Study | 3938.81 ± 155.124 | 3930.57 ± 155.304 | 3892.96 ± 154.413 | 3770.07 ± 153.322 |
OR-SDS: a self-administered assessment of 10 common opioid-related side effects (symptoms). A CME is a severe or very severe symptom (or moderate or greater severity symptom of confusion). The Total Distinct CME score is the sum of CMEs across symptoms (range: 0 \[none\] to 10 \[10 CMEs\]); the Cumulative Total Distinct (CT Distinct) CME score is the sum of Total Distinct CME scores at observation and prior observations. The Total CME score is the same as the Total Distinct CME score except that only 1 CME is counted if both nausea and vomiting (or retching) occur (range: 0 \[none\] to 9 \[9 CMEs\]).
| scores on a scale | Pregabalin 50 mg | Pregabalin 150 mg | Pregabalin 300 mg | Placebo |
|---|---|---|---|---|
| Total CME 3 h PS (n=98, 97, 98, 98) | 0.2 ± 0.07 | 0.2 ± 0.07 | 0.1 ± 0.07 | 0.2 ± 0.07 |
| Total CME 24 h PS (n=97, 97, 98, 97) | 0.2 ± 0.07 | 0.3 ± 0.07 | 0.4 ± 0.07 | 0.2 ± 0.07 |
| Total CME 72 h PS (n=98, 96, 96, 96) | 0.1 ± 0.05 | 0.1 ± 0.05 | 0.2 ± 0.05 | 0.1 ± 0.05 |
| Total CME EOT (n=100, 98, 99, 97) | 0.0 ± 0.04 | 0.1 ± 0.04 | 0.1 ± 0.04 | 0.1 ± 0.04 |
| CT Distinct CME 3 h PS (n=98, 97, 98, 98) | 0.2 ± 0.07 | 0.2 ± 0.07 | 0.1 ± 0.07 | 0.2 ± 0.07 |
| CT Distinct CME 24 h PS (n=93, 95, 96, 94) | 0.3 ± 0.10 | 0.4 ± 0.10 | 0.4 ± 0.09 | 0.4 ± 0.10 |
| CT Distinct CME 72 h PS (n=91, 92, 93, 92) | 0.3 ± 0.11 | 0.5 ± 0.11 | 0.5 ± 0.11 | 0.5 ± 0.11 |
| CT Distinct CME EOT (n=90, 92, 93, 89) | 0.3 ± 0.11 | 0.5 ± 0.11 | 0.6 ± 0.11 | 0.6 ± 0.11 |
OR-SDS: a self-administered assessment of 10 common opioid-related side effects (symptoms). A CME is a severe or very severe symptom (or moderate or greater severity symptom of confusion). For individual symptom categories, the number of subjects who experienced at least one CME. Concentrate (concentr).
| participants | Pregabalin 50 mg | Pregabalin 150 mg | Pregabalin 300 mg | Placebo |
|---|---|---|---|---|
| Fatigue 3 h PS (n=99, 98, 98, 100) | 4 | 2 | 2 | 2 |
| Fatigue 24 h PS (n=99, 97, 100, 97) | 2 | 3 | 6 | 2 |
| Fatigue 72 h PS (n=101, 97, 98, 98) | 0 | 0 | 1 | 1 |
| Fatigue EOT (n=100, 98, 100, 98) | 0 | 0 | 0 | 3 |
| Drowsiness 3 h PS (n=99, 98, 98, 100) | 5 | 4 | 4 | 4 |
| Drowsiness 24 h PS (n=98, 98, 99, 97) | 2 | 7 | 8 | 3 |
| Drowsiness 72 h PS (n=100, 98, 98, 98) | 1 | 0 | 1 | 3 |
| Drowsiness EOT (n=100, 98, 100, 97) | 0 | 0 | 2 | 3 |
| Inability to concentr 3 h PS (n=100, 97, 98, 99) | 1 | 0 | 0 | 2 |
| Inability to concentr 24 h PS (n=99, 98, 100, 97) | 1 | 1 | 2 | 2 |
| Inability to concentr 72 h PS (101, 98, 98, 97) | 0 | 0 | 1 | 1 |
| Inability to concentr EOT (n=100, 98, 100, 99) | 1 | 0 | 0 | 1 |
| Nausea 3 h PS (n=101, 97, 99, 100) | 2 | 1 | 1 | 4 |
| Nausea 24 h PS (n=100, 99, 101, 98) | 3 | 4 | 3 | 1 |
| Nausea 72 h PS (n=101, 99, 99, 98) | 0 | 0 | 0 | 0 |
| Nausea EOT (n=101, 98, 100, 99) | 1 | 0 | 2 | 1 |
| Dizziness 3 h PS (n=101, 97, 99, 100) | 2 | 1 | 5 | 6 |
| Dizziness 24 h PS (n=100, 98, 99, 98) | 2 | 3 | 6 | 1 |
| Dizziness 72 h PS (n=101, 98, 97, 98) | 0 | 0 | 1 | 0 |
| Dizziness EOT (n=101, 98, 100, 99) | 1 | 0 | 1 | 0 |
| Constipation 3 h PS (n=101, 98, 99, 100) | 1 | 0 | 0 | 1 |
| Constipation 24 h PS (n=99, 99, 100, 98) | 4 | 4 | 7 | 5 |
| Constipation 72 h PS (n=99, 97, 98, 98) | 4 | 7 | 10 | 7 |
| Constipation EOT (n=101, 98, 99, 99) | 1 | 2 | 5 | 2 |
| Itching 3 h PS (n=100, 98, 99, 100) | 0 | 1 | 0 | 0 |
| Itching 24 h PS (n=100, 99, 101, 98) | 0 | 0 | 1 | 1 |
| Itching 72 h PS (n=100, 99, 99, 97) | 1 | 1 | 0 | 1 |
| Itching EOT (n=101, 98, 100, 98) | 0 | 0 | 0 | 1 |
| Difficulty Urinating 3 h PS (n=101, 98, 99, 99) | 0 | 3 | 2 | 1 |
| Difficulty Urinating 24 h PS (n=100, 99, 100, 98) | 2 | 4 | 5 | 3 |
| Difficulty Urinating 72 h PS (n=100, 99, 99, 98) | 2 | 0 | 3 | 0 |
| Difficulty Urinating EOT (n= 101, 98, 100, 99) | 1 | 0 | 3 | 0 |
| Confusion 3 h PS (n=101, 98, 99, 100) | 2 | 3 | 3 | 2 |
| Confusion 24 h PS (n=101, 99, 99, 98) | 1 | 1 | 2 | 1 |
| Confusion 72 h PS (n=100, 99, 99, 98) | 2 | 1 | 3 | 2 |
| Confusion EOT (n=101, 98, 100, 99) | 0 | 2 | 0 | 2 |
| Retching/Vomiting 3 h PS (n=101, 98, 99, 100) | 0 | 0 | 0 | 3 |
| Retching/Vomiting 24 h PS (n=101, 99, 100, 98) | 0 | 2 | 0 | 1 |
| Retching/Vomiting 72 h PS (n=101, 99, 99, 98) | 0 | 0 | 0 | 0 |
| Retching/Vomiting EOT (n=101, 98, 100, 99) | 0 | 0 | 0 | 1 |
GESM is a self-administered overall impression (global evaluation) of study medication received for pain; 4 categories: poor, fair, good, and excellent.
| participants | Pregabalin 50 mg | Pregabalin 150 mg | Pregabalin 300 mg | Placebo |
|---|---|---|---|---|
| 24 h PS: Poor (n=100, 96, 101, 99) | 10 | 8 | 7 | 15 |
| 24 h PS: Fair (n=100, 96, 101, 99) | 29 | 28 | 25 | 32 |
| 24 h PS: Good (n=100, 96, 101, 99) | 45 | 46 | 42 | 40 |
| 24 h PS: Excellent (n=100, 96, 101, 99) | 16 | 14 | 27 | 12 |
| EOT: Poor (n=99, 99, 100, 100) | 9 | 10 | 6 | 18 |
| EOT: Fair (n=99, 99, 100, 100) | 14 | 19 | 14 | 19 |
| EOT: Good (n=99, 99, 100, 100) | 45 | 37 | 30 | 32 |
| EOT: Excellent (n=99, 99, 100, 100) | 31 | 33 | 50 | 31 |
Investigator-assigned mutually exclusive categories of: 1) no surgical wound complication, 2) superficial incisional surgical site infection, 3) deep incisional surgical site infection, 4) organ or space surgical site infection, or 5) non-infectious wound healing complication.
| participants | Pregabalin 50 mg | Pregabalin 150 mg | Pregabalin 300 mg | Placebo |
|---|---|---|---|---|
| No surgical wound complication | 102 | 102 | 99 | 101 |
| Superficial incisional surgical site infection | 1 | 0 | 1 | 1 |
| Deep incisional surgical site infection | 0 | 0 | 0 | 0 |
| Organ/space surgical site infection | 0 | 0 | 0 | 0 |
| Non-infectious wound healing complication | 2 | 1 | 1 | 1 |
Number of participants who answered "yes" to the Post-Surgery Contact question: "From the time you were discharged from the hospital, did you have to contact any type of physician because of pain, difficulty getting up and walking about, or difficulty with passing urine?"
| participants | Pregabalin 50 mg | Pregabalin 150 mg | Pregabalin 300 mg | Placebo |
|---|---|---|---|---|
| 24 h PS | 0 | 2 | 1 | 0 |
| 72 h PS | 1 | 3 | 1 | 1 |
Anxiety VAS is a single-item self-administered continuous measure of anxiety using a 100-millimeter (mm) line on which the subject is asked to place a mark indicating the intensity of current anxiety. The score is the distance in mm from the left-most point on the line to the subject's mark; range: 0 (Not at all anxious) at the left-most point to 100 (Extremely anxious) at the right-most point. Performed prior to blood draws.
| scores on a scale | Pregabalin 50 mg | Pregabalin 150 mg | Pregabalin 300 mg | Placebo |
|---|---|---|---|---|
| Baseline (n=101, 98, 100, 100) | 20.2 ± 2.07 | 19.4 ± 2.10 | 18.4 ± 2.07 | 16.4 ± 2.07 |
| 2 h BS (n=101, 98, 100, 99) | 0.2 ± 1.56 | 3.2 ± 1.58 | 1.4 ± 1.54 | 4.2 ± 1.57 |
| 1 h PS (n=100, 96, 99, 99) | -6.4 ± 1.71 | -3.5 ± 1.73 | -5.2 ± 1.68 | -3.2 ± 1.70 |
| 2 h PS (n=101, 98, 100, 100) | -8.4 ± 1.51 | -7.6 ± 1.52 | -7.1 ± 1.48 | -6.1 ± 1.50 |
| 3 h PS (n=101, 98, 100, 100) | -8.7 ± 1.44 | -8.3 ± 1.45 | -9.0 ± 1.42 | -6.4 ± 1.43 |
| Day 2 PS (n=101, 98, 100, 100) | -7.9 ± 1.59 | -10.4 ± 1.60 | -7.5 ± 1.56 | -5.8 ± 1.58 |
| Day 3 PS (n=101, 97, 99, 100) | -9.1 ± 1.23 | -12.7 ± 1.25 | -11.3 ± 1.22 | -9.3 ± 1.23 |
| Day 4 PS (n=101, 98, 98, 101) | -11.1 ± 1.23 | -15.3 ± 1.24 | -12.1 ± 1.23 | -11.4 ± 1.22 |
| Day 5 PS (n=101, 98, 97, 99) | -12.3 ± 1.06 | -15.0 ± 1.07 | -12.4 ± 1.06 | -12.7 ± 1.07 |
| Day 6 PS (n=100, 98, 97, 97) | -12.5 ± 1.08 | -15.0 ± 1.08 | -13.6 ± 1.07 | -12.8 ± 1.09 |
| Day 7 PS (n=97, 93, 89, 95) | -13.0 ± 1.15 | -15.2 ± 1.16 | -13.3 ± 1.19 | -12.4 ± 1.15 |
| Day 8 PS (n=61, 64, 53, 58) | -13.6 ± 1.16 | -15.4 ± 1.11 | -15.5 ± 1.25 | -14.7 ± 1.18 |
| Day 9 PS (n=21, 24, 23, 22) | -16.6 ± 2.07 | -16.4 ± 1.90 | -14.7 ± 1.97 | -12.8 ± 1.90 |
EQ-5D is a self-administered questionnaire to assess health-related quality of life in 5 domains (mobility, self care, usual activities, pain or discomfort, and anxiety or depression). Scores from the 5 domains are used to calculate a single index value: the Health State Profile Score; range: 0.0 (death) to 1.0 (perfect health), higher scores indicating better health state.
| scores on scales | Pregabalin 50 mg | Pregabalin 150 mg | Pregabalin 300 mg | Placebo |
|---|---|---|---|---|
| Baseline (n=101, 99, 100, 100) | 0.66 ± 0.015 | 0.68 ± 0.015 | 0.65 ± 0.015 | 0.66 ± 0.015 |
| Change at EOT (n=97, 98, 99, 98) | -0.01 ± 0.016 | -0.01 ± 0.016 | -0.01 ± 0.015 | -0.04 ± 0.016 |
The PCS is a self-administered questionnaire with 13 items, each scored from 0 (not at all) to 4 (all the time) for extent to which participant catastrophizes postoperative pain. Total score is sum of scores for all questions (range: 0 to 52); Subscale scores: Rumination (sum of scores for 4 items; range: 0 to 16); Magnification (sum of scores for 3 items; range: 0 to 12); and Helplessness (sum of scores for 6 items; range: 0 to 24); higher scores mean a greater extent of pain catastrophizing.
| scores on a scale | Pregabalin 50 mg | Pregabalin 150 mg | Pregabalin 300 mg | Placebo |
|---|---|---|---|---|
| Total score change: 3 h PS (n=99, 98, 98, 99) | -3.5 ± 0.84 | -2.8 ± 0.85 | -3.6 ± 0.83 | -1.5 ± 0.84 |
| Total score change: EOT (n=97, 96, 98, 96) | -6.2 ± 0.64 | -5.8 ± 0.64 | -6.3 ± 0.63 | -5.7 ± 0.64 |
| Rumination change: 3 h PS (n=99, 98, 98, 99) | -1.0 ± 0.35 | -0.7 ± 0.35 | -1.1 ± 0.35 | -0.4 ± 0.35 |
| Rumination change: EOT (n=97, 96, 98, 96) | -2.3 ± 0.28 | -1.8 ± 0.28 | -2.2 ± 0.27 | -1.9 ± 0.28 |
| Magnification change: 3 h PS (n=99, 98, 99, 99) | -0.9 ± 0.21 | -0.9 ± 0.21 | -1.1 ± 0.21 | -0.7 ± 0.21 |
| Magnification change: EOT (n=97, 96, 99, 96) | -1.5 ± 0.17 | -1.7 ± 0.17 | -1.6 ± 0.17 | -1.4 ± 0.17 |
| Helplessness change: 3 h PS (n=99, 98, 99, 99) | -1.5 ± 0.37 | -1.3 ± 0.38 | -1.4 ± 0.37 | -0.5 ± 0.37 |
| Helplessness change: EOT (n=97, 96, 99, 96) | -2.4 ± 0.27 | -2.3 ± 0.27 | -2.5 ± 0.26 | -2.5 ± 0.27 |
The PCS is a self-administered questionnaire with 13 items, each scored from 0 (not at all) to 4 (all the time) for extent to which participant catastrophizes postoperative pain. Total score is sum of scores for all items (range: 0 to 52); higher scores mean a greater extent of pain catastrophizing.
No measurements were reported for this outcome.
PCSS and MCSS are component summary scores from the self-administered SF-12v2 acute health quality of life, norm-based survey. PCSS range: 4.95 to 76.13; MCSS range: -0.79 to 79.69; lowest scores mean very much below and highest scores mean very much above the general population average.
| scores on a scale | Pregabalin 50 mg | Pregabalin 150 mg | Pregabalin 300 mg | Placebo |
|---|---|---|---|---|
| PCSS at baseline (n=101, 99, 100, 100) | 46.43 ± 0.914 | 48.14 ± 0.928 | 46.44 ± 0.915 | 44.89 ± 0.917 |
| PCSS change at EOT (n=99, 99, 99, 98) | -6.86 ± 1.013 | -7.06 ± 1.021 | -6.92 ± 1.011 | -8.21 ± 1.025 |
| MCSS at baseline (n=101, 99, 100, 100) | 54.48 ± 0.787 | 54.58 ± 0.799 | 54.81 ± 0.787 | 56.18 ± 0.789 |
| MCSS change at EOT (n=99, 99, 99, 98) | 2.65 ± 0.764 | 2.68 ± 0.762 | 3.27 ± 0.750 | 1.50 ± 0.765 |
Number of participants who reported surgery-related pain at assessment (by answering 'yes' to a single question: "In the last 24 hours, have you had pain in the area affected by your surgery?")
| participants | Pregabalin 50 mg | Pregabalin 150 mg | Pregabalin 300 mg | Placebo |
|---|---|---|---|---|
| 1 month PS (n=98, 98, 98, 99) | 20 | 24 | 19 | 26 |
| 3 month PS (n=98, 97, 97, 97) | 3 | 5 | 5 | 3 |
| 6 month PS (n=98, 97, 97, 97) | 1 | 1 | 1 | 0 |
m-BPI-sf: a self-administered 11-point Likert rating scale to rate pain in the past 24 hours. Pain interference index score is mean of 7 individual item scores for interference of pain with functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life); range: 0 (does not interfere) to 10 (completely interferes with functional activities). Pain severity index score is mean of 4 individual item scores for pain severity (pain right now, and worst, least, and average pain); range: 0 (no pain) to 10 (worst imaginable pain).
| scores on a scale | Pregabalin 50 mg | Pregabalin 150 mg | Pregabalin 300 mg | Placebo |
|---|---|---|---|---|
| Pain Severity 1 mo PS (n=20, 24, 19, 26) | 0.86 ± 0.801 | 0.81 ± 0.767 | 1.43 ± 1.210 | 0.76 ± 0.654 |
| Pain Severity 3 mo PS (n=3, 5, 5, 3) | 0.58 ± 0.629 | 0.75 ± 0.354 | 1.55 ± 1.052 | 0.42 ± 0.520 |
| Pain Interference 1 mo PS (n=20, 24, 19, 26) | 0.39 ± 0.630 | 0.71 ± 0.974 | 1.29 ± 1.463 | 0.51 ± 0.895 |
| Pain Interference 3 mo PS (n=3, 5, 5, 3) | 0.14 ± 0.143 | 0.20 ± 0.163 | 1.34 ± 2.140 | 0.00 ± 0.000 |
NPSI: a 12-item self-administered questionnaire to assess the characteristics of neuropathic pain on average in the last 24 hours. 5 subscale scores include: burning spontaneous (spont.) pain, pressing spont. pain, paroxysmal pain, evoked pain, and paresthesia or dysesthesia (paresth/dysesth) (range: 0 \[no pain\] to 10 \[worst pain imaginable\]); total score calculated from the 5 pain subscores (range: 0 to 0.5), higher scores meaning worse pain.
| scores on a scale | Pregabalin 50 mg | Pregabalin 150 mg | Pregabalin 300 mg | Placebo |
|---|---|---|---|---|
| NPSI total score 1 mo PS (n=20, 24, 19, 26) | 0.03 ± 0.025 | 0.03 ± 0.048 | 0.05 ± 0.038 | 0.04 ± 0.041 |
| NPSI total score 3 mo PS (n=3, 5, 5, 3) | 0.02 ± 0.032 | 0.02 ± 0.022 | 0.05 ± 0.034 | 0.04 ± 0.044 |
| Burning spont. pain 1 mo PS (n=20, 24, 19, 26) | 0.30 ± 0.571 | 1.04 ± 1.574 | 1.11 ± 1.761 | 0.77 ± 1.557 |
| Burning spont. pain 3 mo PS (n=3, 5, 5, 3) | 1.00 ± 1.732 | 0.00 ± 0.00 | 0.40 ± 0.894 | 1.00 ± 1.732 |
| Pressing spont. pain 1 mo PS (n=20, 24, 19, 26) | 0.43 ± 0.545 | 0.50 ± 1.189 | 1.03 ± 1.307 | 0.69 ± 0.939 |
| Pressing spont. pain 3 mo PS (n=3, 5, 5, 3) | 0.50 ± 0.500 | 0.50 ± 0.354 | 2.30 ± 1.754 | 0.67 ± 0.764 |
| Paroxysmal pain 1 mo PS (n=20, 24, 19, 26) | 0.95 ± 1.708 | 0.56 ± 1.106 | 1.05 ± 1.499 | 0.71 ± 1.133 |
| Paroxysmal pain 3 mo PS (n=3, 5, 5, 3) | 0.33 ± 0.289 | 0.20 ± 0.274 | 0.70 ± 0.447 | 1.33 ± 1.528 |
| Evoked pain 1 mo PS (n=20, 24, 19, 26) | 0.82 ± 0.970 | 0.76 ± 0.990 | 1.44 ± 1.495 | 1.05 ± 1.472 |
| Evoked pain 3 mo PS (n=3, 5, 5, 3) | 0.22 ± 0.192 | 1.3 ± 2.082 | 1.73 ± 1.234 | 0.44 ± 0.509 |
| Paresth/dysesth 1 mo PS (n=20, 24, 19, 26) | 0.10 ± 0.308 | 0.35 ± 0.961 | 0.32 ± 0.768 | 0.46 ± 0.774 |
| Paresth/dysesth 3 mo PS (n=3, 5, 5, 3) | 0.50 ± 0.866 | 0.20 ± 0.274 | 0.10 ± 0.224 | 0.50 ± 0.866 |
Collected over Baseline (Day 0) through post-treatment phone contact (Month 6). Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pregabalin 50 mg | — | 3/108 (2.8%) | 46/108 (42.6%) |
| Pregabalin 150 mg | — | 1/106 (0.9%) | 44/106 (41.5%) |
| Pregabalin 300 mg | — | 0/103 (0%) | 56/103 (54.4%) |
| Placebo | — | 3/108 (2.8%) | 45/108 (41.7%) |
| Event | Pregabalin 50 mg | Pregabalin 150 mg | Pregabalin 300 mg | Placebo |
|---|---|---|---|---|
| AmnesiaNervous system disorders | 0/108 | 1/106 | 0/103 | 0/108 |
| Abdominal painGastrointestinal disorders | 0/108 | 0/106 | 0/103 | 1/108 |
| Gastric ulcer haemorrhageGastrointestinal disorders | 1/108 | 0/106 | 0/103 | 0/108 |
| VomitingGastrointestinal disorders | 0/108 | 0/106 | 0/103 | 1/108 |
| PyrexiaGeneral disorders | 0/108 | 0/106 | 0/103 | 1/108 |
| Muscular weaknessMusculoskeletal and connective tissue disorders | 1/108 | 0/106 | 0/103 | 0/108 |
| Guillain-Barre syndromeNervous system disorders | 1/108 | 0/106 | 0/103 | 0/108 |
| HaematomaVascular disorders | 0/108 | 0/106 | 0/103 | 1/108 |
| Event | Pregabalin 50 mg | Pregabalin 150 mg | Pregabalin 300 mg | Placebo |
|---|---|---|---|---|
| DizzinessNervous system disorders | 15/108 | 20/106 | 29/103 | 16/108 |
| ConstipationGastrointestinal disorders | 21/108 | 22/106 | 27/103 | 27/108 |
| SomnolenceNervous system disorders | 24/108 | 25/106 | 25/103 | 28/108 |
| FatigueGeneral disorders | 24/108 | 18/106 | 23/103 | 23/108 |
| NauseaGastrointestinal disorders | 21/108 | 18/106 | 14/103 | 22/108 |
| Disturbance in attentionNervous system disorders | 11/108 | 11/106 | 15/103 | 16/108 |
| DysuriaRenal and urinary disorders | 10/108 | 6/106 | 10/103 | 10/108 |
| PruritusSkin and subcutaneous tissue disorders | 9/108 | 7/106 | 4/103 | 6/108 |
| Confusional statePsychiatric disorders | 6/108 | 3/106 | 8/103 | 6/108 |
| VomitingGastrointestinal disorders | 2/108 | 7/106 | 1/103 | 6/108 |
| Age, Customized(participants) | Pregabalin 50 mg | Pregabalin 150 mg | Pregabalin 300 mg | Placebo | Total |
|---|---|---|---|---|---|
| Between 18 and 44 years | 43 | 37 | 40 | 46 | 166 |
| Between 45 and 64 years | 48 | 58 | 52 | 47 | 205 |
| >=65 years | 17 | 11 | 11 | 15 | 54 |
| Sex/Gender, Customized(participants) | Pregabalin 50 mg | Pregabalin 150 mg | Pregabalin 300 mg | Placebo | Total |
|---|---|---|---|---|---|
| Number | 108 | 106 | 103 | 108 | 425 |
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