NCT02355886

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

Randomized Placebo Control Trial of Perioperative Gabapentin to Reduce Total Analgesic Requirements in Patients Undergoing Radical Cystectomy

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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). 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.

Conditions

• Bladder Carcinoma

Interventions

Type	Name	Description
DRUG	Gabapentin	Given PO
OTHER	Placebo	Given PO
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2015-04-22
• Primary completion: 2018-02-28
• Completion: 2019-02-28
• First posted: 2015-02-04
• Last updated: 2019-06-04
• Results posted: 2019-06-04

Locations

1 site across 1 country: United States