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

Phase 2

Completed

• Conditions: Bladder Carcinoma
• Interventions: Other: Placebo; Drug: Gabapentin; Other: Questionnaire Administration

• Registration Number: NCT02355886
• Lead Sponsor: University of Washington

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).

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.

Study Timeline

• Study First Submitted: 2015-01-30
• Study First Submitted QC: 2015-01-30
• Study First Posted: 2015-02-04
• Study Start: 2015-04-22
• Primary Completion: 2018-02-28
• Results First Submitted: 2019-02-25
• Study Completion: 2019-02-28
• Status Verified: 2019-05
• Results First Submitted QC: 2019-05-13
• Last Update Submitted: 2019-05-13
• Results First Posted: 2019-06-04
• Last Update Posted: 2019-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm II (placebo)	Questionnaire Administration	Patients receive placebo PO TID for 48 hours after surgery.
Arm II (placebo)	Placebo	Patients receive placebo PO TID for 48 hours after surgery.
Arm I (gabapentin)	Questionnaire Administration	Patients receive gabapentin PO TID for 48 hours after surgery.
Arm I (gabapentin)	Gabapentin	Patients receive gabapentin PO TID for 48 hours after surgery.

Primary Outcome Measures

Name	Time	Method
Patient Total Equivalent Analgesic Requirement (Morphine Equivalents)	48 hours post-radical cystectomy	Geometric Mean and Standard Deviation of patient total equivalent analgesic

Secondary Outcome Measures

Name	Time	Method
Patient Self-assessed Pain on Numerical Pain Scale	Up to 48 hours post-radical cystectomy	The two study groups compared on Patient self-assessed pain on numerical pain likert scale. Numeric Pain Scale was utilized with values of 0-10 with increasing severity.
Length of Stay Following Radical Cystectomy	duration of hospital stay. Days to weeks	The two study groups will be compared by Length of stay following radical cystectomy

Trial Locations

Locations (1)

Fred Hutch/University of Washington Cancer Consortium; 🇺🇸 Seattle, Washington, United States