A Phase 4 interventional study of Placebo and Gabapentin in Anesthesia and Urethral Obstruction, sponsored by Northwestern University. Terminated at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-07-21.
Sponsored by Northwestern University · Phase 4, Interventional, and Prevention
The study's objective is to determine the efficacy of preoperative gabapentin in relieving postoperative pain, reducing opioid use and improving quality of recovery in subjects undergoing urologic surgery.
Investigators hypothesize that subjects receiving gabapentin will have lower pain scores, less opioid consumption and better quality of recovery as compared to subjects who are given a placebo.
Approximately one hour prior to induction of anesthesia in preoperative holding area all enrolled subjects will receive PO Acetaminophen 650 mg, the Gabapentin group will receive PO Gabapentin 1200 mg, while the Control group will receive PO Placebo, with a small amount of water.
Upon arrival in the operating room, standard ASA monitors will be applied. Intraoperative, patients will receive a standardized anesthetic care. This care consists of induction with IV propofol 2mg/kg, IV fentanyl 2 mcg/kg (adjusted body weight), and IV rocuronium 0.6 mg/kg for tracheal intubation or IV succinylcholine 1mg/kg if rapid sequence induction is needed.
For maintenance of general anesthesia, investigators will use Sevoflurane, with the goal to maintain BP within 20% of preoperative baseline and BIS 40-60.
If HR > 100/min and BIS 40-60 may use IV esmolol 0.5 mg/kg. If BP and/or HR >20% preoperative baseline, and BIS 40- 60 despite above management, may titrate IV antihypertensive agents.
For PONV prophylaxis, 30 min before end of surgery investigatorswill administer IV ondansetron 8mg.
The time from end of surgery to extubation in OR will be documented with a free text note in the EMR.
After extubation all patients will be transported to PACU on 2-liter Oxygen by nasal cannula, which will be weaned off in the PACU.
The postoperative analgesics during Phase I of recovery in PACU will consist of IV Hydromorphone 0.2-0.4 mg prn pain to maintain adequate pain control (NPRS\<4). During Phase II of recovery patients will receive PO Hydromorphone 2mg tablets every 4-6 hours as needed for pain (NPRS ≥ 4) and acetaminophen: 650mg PO every 6 hours
The following data will be collected every hour during phase I and phase II recovery:
Study research personnel will contact participants by phone or in the hospital at 24 hours and 48 hours postoperative and at approximately one week in the Urology clinic. The study research personnel will ask questions regarding pain (NPRS) and analgesic consumption. The IPSS and QOR-40 questionnaires will be administered and data will be recorded.
Exclusion Criteria:
Placebo pill administered 1 hour before planned surgical procedure
Drug: Placebo
Gabapentin pill (1200mg) administered orally 1 hour prior to planned surgical procedure
Drug: Gabapentin
Placebo pill administered orally 1 hour before planned surgical procedure
Gabapentin pill (1200mg) administered orally 1 hour before planned surgical procedure
48 Hours Morphine Equivalents Consumed.
Total morphine equivalents in milligrams consumed during the first 48 hours after surgery.
Time frame: Up to 48 hours after surgery
24 Hour Pain Burden
Pain scores using an 11 point numeric pain rating scale 0=no pain 10 = worst pain imaginable
Time frame: 24 hours after surgery
QOR 40 Questionnaire Scores
Evaluate quality of recovery using the Quality of Recovery 40 (QoR 40) questionnaire a 40 question survey scored from 40 ( poor recovery) to 200 high (good recovery) 48 hours after the surgical procedure.
Time frame: 48 hours after surgical procedure
| Milestone | Placebo | Gabapentin |
|---|---|---|
| Started | 9 | 11 |
| Completed | 9 | 11 |
| Not completed | 0 | 0 |
Total morphine equivalents in milligrams consumed during the first 48 hours after surgery.
| morphine milligrams | Placebo | Gabapentin |
|---|---|---|
| 48 Hours Morphine Equivalents Consumed. | 51.87 (0 to 204) | 15.71 (0 to 48) |
Pain scores using an 11 point numeric pain rating scale 0=no pain 10 = worst pain imaginable
| score on a scale | Placebo | Gabapentin |
|---|---|---|
| 24 Hour Pain Burden | 4.11 ± 2.26 | 3.11 ± 2.67 |
Evaluate quality of recovery using the Quality of Recovery 40 (QoR 40) questionnaire a 40 question survey scored from 40 ( poor recovery) to 200 high (good recovery) 48 hours after the surgical procedure.
| score on a scale | Placebo | Gabapentin |
|---|---|---|
| QOR 40 Questionnaire Scores | 181.3 (160 to 198) | 187.5 (171 to 200) |
Collected over 7 days after surgical procedure.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/9 (0%) | 0/9 (0%) | 2/9 (22.2%) |
| Gabapentin | 0/11 (0%) | 0/11 (0%) | 2/11 (18.2%) |
| Event | Placebo | Gabapentin |
|---|---|---|
| NauseaGastrointestinal disorders | 1/9 | 2/11 |
| HeadacheMusculoskeletal and connective tissue disorders | 0/9 | 2/11 |
| DizzinessGeneral disorders | 1/9 | 2/11 |
| Age, Continuous(years) | Placebo | Gabapentin | Total |
|---|---|---|---|
| Mean | 49 ± 16.4 | 49 ± 14.72 | 49 ± 14.9 |
| Sex: Female, Male(Participants) | Placebo | Gabapentin | Total |
|---|---|---|---|
| Female | 3 | 3 | 6 |
| Male | 6 | 8 | 14 |
| Ethnicity (NIH/OMB)(Participants) | Placebo | Gabapentin | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 1 | 3 |
| Not Hispanic or Latino | 7 | 10 | 17 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Placebo | Gabapentin | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 1 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 1 |
| White | 7 | 10 | 17 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Placebo | Gabapentin | Total |
|---|---|---|---|
| United States | 9 | 11 | 20 |
| Height (Inches)(Inches) | Placebo | Gabapentin | Total |
|---|---|---|---|
| Mean | 67.2 ± 3.27 | 67.7 ± 4.33 | 67.5 ± 3.89 |
| Weight (kilograms)(Kilograms) | Placebo | Gabapentin | Total |
|---|---|---|---|
| Mean | 89.58 ± 21.6 | 76.1 ± 17.48 | 83.4 ± 19.74 |
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Urethral Obstruction
Northwestern University