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

Bladder Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02355886
• Other study ID #: 9274
• Secondary ID: NCI-2015-0008392
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: April 22, 2015
• Est. completion date: February 28, 2019

Study information

• Verified date: May 2019
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: February 28, 2019
• Est. primary completion date: February 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Bladder Carcinoma
• Urinary Bladder Neoplasms

Intervention

Drug:
• Gabapentin
Given PO

Other:
• Placebo
Given PO
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Fred Hutch/University of Washington Cancer Consortium	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Total Equivalent Analgesic Requirement (Morphine Equivalents)	Geometric Mean and Standard Deviation of patient total equivalent analgesic	48 hours post-radical cystectomy
Secondary	Length of Stay Following Radical Cystectomy	The two study groups will be compared by Length of stay following radical cystectomy	duration of hospital stay. Days to weeks
Secondary	Patient Self-assessed Pain on Numerical Pain Scale	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.	Up to 48 hours post-radical cystectomy