Seattle, Washington 98109


Purpose:

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.


Study summary:

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). 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.


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 < 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)


NCT ID:

NCT02355886


Primary Contact:

Principal Investigator
Jonathan Wright
Fred Hutch/University of Washington Cancer Consortium


Backup Contact:

N/A


Location Contact:

Seattle, Washington 98109
United States

George R. Schade
Email: grschade@uw.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: June 25, 2018

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