Randomized Placebo Control Trial of Perioperative Gabapentin to Reduce Total Analgesic Requirements in Patients Undergoing Radical Cystectomy
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- University of Washington
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Patient Total Equivalent Analgesic Requirement (Morphine Equivalents)
Study Overview
Brief 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.
Detailed Description
PRIMARY OBJECTIVES:
I. To assess if perioperative gabapentin will decrease post-operative analgesic requirements within the first 48 hours after radical cystectomy (RC) in patients undergoing RC as measured morphine equivalents.
SECONDARY OBJECTIVES:
I. To assess patient self-assessment of postoperative pain on Numeric Pain Scale (NPS) at 24 and 48 hours.
II. To assess time to return of bowel function (ROBF).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
Arm II (placebo)
Patients receive placebo PO TID for 48 hours after surgery.
Intervention: Questionnaire Administration (Other)
Arm I (gabapentin)
Patients receive gabapentin PO TID for 48 hours after surgery.
Intervention: Gabapentin (Drug)
Arm I (gabapentin)
Patients receive gabapentin PO TID for 48 hours after surgery.
Intervention: Questionnaire Administration (Other)
Arm II (placebo)
Patients receive placebo PO TID for 48 hours after surgery.
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
Patient Total Equivalent Analgesic Requirement (Morphine Equivalents)
Time Frame: 48 hours post-radical cystectomy
Geometric Mean and Standard Deviation of patient total equivalent analgesic
Secondary Outcomes
- Patient Self-assessed Pain on Numerical Pain Scale(Up to 48 hours post-radical cystectomy)
- Length of Stay Following Radical Cystectomy(duration of hospital stay. Days to weeks)