A Phase 3 interventional study of Gabapentin and Placebo in Pain, Postoperative, sponsored by University of Aarhus. Completed at 1 site in Denmark. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2014-08-05.
Sponsored by University of Aarhus · Phase 3, Interventional, and Prevention
The purpose of this trial is to investigate the effect of gabapentin on thoracic epidural analgesia following thoracotomy, including assessment of both analgesia, pain intensity, pain quality and whether or not gabapentin prevents the development of chronic pain conditions following thoracotomy.
The main hypothesis is that gabapentin reduces the proportion of patients who develop a persistent pain condition following thoracotomy from 50% to 20%.
Furthermore gabapentin is expected to reduce both pain intensity measured on a 11-point numerical rating scale, usage of epidural infusions of local and/or opioid analgesics, morbidity, hospital length of stay, consumption of opioid analgesics and analgesia-related side-effects.
In addition gabapentin is expected to improve postoperative recovery by means of postoperative lung function, walking ability, health related quality of life and patient satisfaction
5,224 studies on the registry are indexed under Pain, Postoperative; 1,154 are open to participants now.
This study's enrollment of 104 is above the median of 75 across 4,457 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →University of Aarhus is the lead sponsor of 1,299 studies on the registry; 189 are open to participants now.
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Exclusion Criteria:
Gabapentin group
Drug: Gabapentin
Placebo group
Drug: Placebo
Preoperatively (2 hours before surgery): 4 gabapentin capsules each containing 300 mg gabapentin (total gabapentin dose 1200 mg) Postoperative day 1: gabapentin 300 mg x 2 (total gabapentin dose 600 mg) Postoperative day 2: gabapentin 300 mg x 3 (total gabapentin dose 900 mg) Postoperative day 3: gabapentin 300 mg x 4 (total gabapentin dose 1200 mg) Postoperative day 4: gabapentin 300 mg x 4 (total gabapentin dose 1200 mg) Postoperative day 5: gabapentin 300 mg x 4 (total gabapentin dose 1200 mg)
Also known as: Gabapentin "Sandoz" 300 mg
Preoperatively (2 hours before surgery): 4 placebo capsules Postoperative day 1: 1 placebo capsule x 2 Postoperative day 2: 1 placebo capsule x 3 Postoperative day 3: 1 placebo capsule x 4 Postoperative day 4: 1 placebo capsule x 4 Postoperative day 5: 1 placebo capsule x 4
Persistent post surgical pain
Pain is assessed by means of the Brief Pain Inventory (BPI-SF) and The McGill Pain Questionnaire (SF-MPQ). Persistent postoperative pain is measured both on a 11-point numeric pain rating scale and on a 10 cm visual analog scale (VAS). A score \>=3 is considered as moderate pain.
Time frame: 3 months after surgery
Acute postoperative pain
Acute postoperative pain is measured on a 11-point numeric rating scale both at rest and when coughing/sitting up. General pain intensity and specific (shoulder) pain intensity are measured. On postoperative day 4 pain is furthermore assessed by means of the Brief Pain Inventory (BPI-SF) and The McGill Pain Questionnaire (SF-MPQ). A score \>=3 is considered as moderate pain.
Time frame: Within the first 5 postoperative days
Usage of epidural infusion of local and opioid analgesics (ml)
Time frame: Within the first 5 postoperative days
Persistent post surgical pain
Pain is assessed by means of the Brief Pain Inventory (BPI-SF) and The McGill Pain Questionnaire (SF-MPQ). Persistent postoperative pain is measured both on a 11-point numeric pain rating scale and on a 10 cm visual analog scale (VAS). A score \>=3 is considered as moderate pain.
Time frame: 6 months following surgery
Persistent post surgical pain
Pain is assessed by means of the Brief Pain Inventory (BPI-SF) and The McGill Pain Questionnaire (SF-MPQ). Persistent postoperative pain is measured both on a 11-point numeric pain rating scale and on a 10 cm visual analog scale (VAS). A score \>=3 is considered as moderate pain.
Time frame: 12 months following surgery
Early postoperative pain
Early postoperative pain is measured on day 14 (+/-3 days) following discharge pain using the Brief Pain Inventory (BPI-SF) and The McGill Pain Questionnaire (SF-MPQ). A score \>=3 is considered as moderate pain.
Time frame: 14 days (+/-3 days) following discharge
Consumption of opioid analgesics
Time frame: Within the first 5 postoperative days
Time to first request for additional analgesics
Time frame: Within the first 5 postoperative days
Analgesia related side-effects
Evaluation of the presence and/or severity of confusion, hallucinations, nausea, vomiting, usage of antiemetic drugs, urinary retention, sedation, pruitus, headache, respiratory depression, motor blockade and dizziness
Time frame: Within the first 5 postoperative days
Convalescence of gastrointestinal function
Convalescence of gastrointestinal function (time to first defecation)
Time frame: Within the first 5 postoperative days
Health related quality of life
Health related quality of life is measured with the EORCT QLQ-C30 and EORCT QLQ-LC13 questionnaires.
Time frame: Day 14 (+/-3 days) following discharge
Patient satisfaction
Patient satisfaction is assesed with the EORCT-INPATSAT32 questionnaire
Time frame: Within the first 5 postoperative days
Intensity of preoperative anxiety
Anxiety is measured on a 11-point numeric rating scale (NRS).
Time frame: 2 hours after administration of the first dose of study medication
Convalescence of lung function (spirometry)
FVC, FEV-1 and PEF is measured.
Time frame: Within the first five postoperative days
Sleep quality
Sleep quality is measured on a 11-point numeric rating scale (NRS)
Time frame: Within the first five postoperative days
Walking distance (meters)
Ability to walk is measured by means of the 6-minutes walking test on postoperative day 3.
Time frame: Postoperative day 3
Fatigue
Fatigue is measured on a 4-point verbal rating scale (0=None, 1=Mild, 2=Moderate, 3=Severe).
Time frame: Within the first 5 postoperative days
Hospital length of stay (days)
Time frame: At time of discharge
Health related quality of life
Health related quality of life is measured with the EORCT QLQ-C30 and EORCT QLQ-LC13 questionnaires.
Time frame: 3 months following surgery
Health related quality of life
Health related quality of life is measured with the EORCT QLQ-C30 and EORCT QLQ-LC13 questionnaires.
Time frame: 6 months following surgery
Health related quality of life
Health related quality of life is measured with the EORCT QLQ-C30 and EORCT QLQ-LC13 questionnaires.
Time frame: 12 months following surgery
Use of a vasopressor agent to correct hypotension
Time frame: Within the first 5 days of surgery
This study is completed, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Gabapentin