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

University of Washington

Status and phase: Completed; Phase 3; Phase 2

Conditions: Bladder Carcinoma

Treatments: Other: Questionnaire Administration; Other: Placebo; Drug: Gabapentin

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02355886

9274 (Other Identifier)

NCI-2015-00083 (Registry Identifier)

P30CA015704 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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25 participants in 2 patient groups, including a placebo group

Arm I (gabapentin)

Experimental group

Description:

Patients receive gabapentin PO TID for 48 hours after surgery.

Treatment:

Drug: Gabapentin

Other: Questionnaire Administration

Arm II (placebo)

Placebo Comparator group

Description:

Patients receive placebo PO TID for 48 hours after surgery.

Treatment:

Other: Placebo

Other: Questionnaire Administration