Phase 3
N=25
Gabapentin in Reducing the Need for Pain Medication in Patients With Bladder Cancer Undergoing Radical Cystectomy
Bladder Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT02355886 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcome: Primary: Patient Total Equivalent Analgesic Requirement (Morphine Equivalents) — 297.65; 396.16 Total oral morphine equivalents in mg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Gabapentin (Drug); Placebo (Other); Questionnaire Administration (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Washington
- Primary completion
- Feb 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient Total Equivalent Analgesic Requirement (Morphine Equivalents) |
297.65; 396.16 | — |
| SECONDARY Length of Stay Following Radical Cystectomy |
6.58; 6.73 | — |
| SECONDARY Patient Self-assessed Pain on Numerical Pain Scale |
5.15; 7.67 | — |
Summary
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.
Eligibility Criteria
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 90 days)
Data sourced from ClinicalTrials.gov (NCT02355886). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.