Gabapentin in Reducing the Need for Pain Medication in Patients With Bladder Cancer Undergoing Radical Cystectomy

• Status: Completed
• Trial end date: 2019-02-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Washington
• Collaborator: National Cancer Institute (NCI)
• Treatments: Gabapentin; gamma-Aminobutyric Acid

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)