Clinical trial · Interventional
Gabapentin in Reducing the Need for Pain Medication in Patients With Bladder Cancer Undergoing Radical Cystectomy
Randomized Placebo Control Trial of Perioperative Gabapentin to Reduce Total Analgesic Requirements in Patients Undergoing Radical Cystectomy
NCT02355886CI-TRIAL-00038899completedPhase 2 / Phase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- 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)
This randomized phase II/III trial studies gabapentin in reducing the need for pain medication in patients with bladder cancer undergoing surgery to remove the bladder and nearby tissue and organs. Gabapentin may reduce the amount of pain medicine required after surgery, improve pain after surgery, and/or reduce the length of hospital stay after surgery.
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 |
|---|---|---|---|
| Bladder Carcinoma | Bladder Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gabapentin | Drug | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (gabapentin)
- description
- Patients receive gabapentin PO TID for 48 hours after surgery.
- interventionNames
- Drug: Gabapentin
- Other: Questionnaire Administration
- type
- PLACEBO_COMPARATOR
- label
- Arm II (placebo)
- description
- Patients receive placebo PO TID for 48 hours after surgery.
- interventionNames
- Other: Placebo
- Other: Questionnaire Administration
Primary outcomes (1)
- measure
- Patient Total Equivalent Analgesic Requirement (Morphine Equivalents)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of bladder cancer * Anticipated radical cystectomy with ileal conduit or orthotopic neobladder Exclusion Criteria: * Presence of spinal cord injury including any form of paraplegia or quadriplegia * Allergy to gabapentin * Active alcohol dependence, defined as 2 or more positive questions on the CAGE alcoholism questionnaire * Illicit drug use (excluding recreational marijuana) * Chronic kidney disease with glomerular filtration rate \< 30 ml/min * Pregnancy: All female patients \< 55 years old (yo) will be administered a urine pregnancy test prior to enrollment * Non-English speaking patients * Chronic gabapentin, or the similar drug pregabalin, use * Chronic narcotic use (daily or near daily use for \> 90 days)
References
Publications (0)
Data not yet available
No reference posted for this study.