Bladder Cancer Clinical Trial
Gabapentin in Reducing the Need for Pain Medication in Patients With Bladder Cancer Undergoing Radical Cystectomy
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.
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.
Eligibility Criteria
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)
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There is 1 Location for this study
Seattle Washington, 98109, United States
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