Clinical trial · Interventional
Does Postoperative Gabapentin Reduce Pain, Opioid Consumption and Anxiety and Have a Positive Effect on Health Related Quality of Life After Radical Prostatectomy?
Does Postoperative Gabapentin Reduce Pain, Opioid Consumption & Anxiety & Have a Positive Effect on Health Related Quality of Life After Radical Prostatectomy?
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The Acute Pain Service (APS) at Sunnybrook has been using Gabapentin 200 mg three times a day (TID) resulting in anecdotal benefits in terms of analgesia and opioid sparing effects. Higher doses of Gabapentin were associated with an increased incidence of sedation. The purpose of the study is to investigate if Gabapentin 200 mg given three times a day for 72 hours (9doses) results in a reduction in the total amount of opioid required after radical prostatectomy surgery as compared to placebo, and if analgesia is improved. This study will also examine the possible anxiety sparing effects and any health related quality of life (HRQL) changes, which may be a result of our perioperative use of gabapentin.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gabapentin | Drug | — | UNRESOLVED |
| Placebo Sugar Pill | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Placebo Sugar Pill
- description
- Patients are stratified based on their initial pain score in the recovery room. patients with a pain numeric rating scale of greater than or equal to 7/10 are stratified to the "high" group. then randomized to receive gabapentin 200 mg tid x 9 doses, or placebo x 9 doses. Patients with a pain score equal to or less than 6/10 are stratified to the "low" group, then randomized to receive gabapentin 200mg tid x 9 doses or placebo x 9 doses. All patients receive Acetaminophen 1gm every 6 hours for 3 days, Celecoxib 400mg as a loading dose then 200mg twice a day for 3 days. Patients also receive patient controlled analgesia (PCA) of hydromorphone for 24 hrs, then are transitioned to oxycodone 5-15 mg every 2 hours as needed.
- interventionNames
- Drug: Placebo Sugar Pill
- type
- ACTIVE_COMPARATOR
- label
- Gabapentin 200 mg tid x 9 doses
- interventionNames
- Drug: Gabapentin
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Undergoing radical prostatectomy * Able to read and write english (assistance is allowed) * Normal creatinine blood serum level * No known allergies to study medications Exclusion Criteria: * Patients not providing informed consent * Patients less than 18 years of age or greater than 75 years of age * Known allergy to any of the medications being used * History of drug or alcohol abuse * Preoperative pain * Patients unable or unwilling to use PCA * Patients with impaired renal function (Creatinine \>106)
References
Publications (0)
Data not yet available