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.
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
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).
III. To assess length of stay (LOS) following RC.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive gabapentin orally (PO) thrice daily (TID) for 48 hours after surgery.
ARM II: Patients receive placebo PO TID for 48 hours after surgery.
|Overal Status||Start Date||Phase||Study Type|
|Recruiting||April 22, 2015||Phase 2/Phase 3||Interventional|
Primary Outcome 1 - Measure: Patient total equivalent analgesic requirement (morphine equivalents)
Primary Outcome 1 - Time Frame: 48 hours post-radical cystectomy
- Diagnosis of bladder cancer
- Anticipated radical cystectomy with ileal conduit or orthotopic neobladder
- 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
- 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)
Minimum Age: 18 Years
Maximum Age: 75 Years
Healthy Volunteers: No
Name: Jonathan Wright
Role: Principal Investigator
Affiliation: Fred Hutch/University of Washington Cancer Consortium
|Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington 98109
George R. Schade