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



Status:Active, not recruiting
Healthy:No
Age Range:18 - 75
Updated:4/17/2018
Start Date:April 22, 2015
End Date:February 28, 2019

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

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.

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.

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)
We found this trial at
1
site
Seattle, Washington 98109
Principal Investigator: Jonathan L. Wright
?
mi
from
Seattle, WA
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