Clinical trial NCT02355886: Gabapentin in Reducing the Need for Pain Medication in Patients With Bladder Cancer Undergoing Radical Cystectomy
Official title: Randomized Placebo Control Trial of Perioperative Gabapentin to Reduce Total Analgesic Requirements in Patients Undergoing Radical Cystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Bladder Carcinoma
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2015-02-04
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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)

Primary outcomes:
measure: Patient Total Equivalent Analgesic Requirement (Morphine Equivalents)
timeFrame: 48 hours post-radical cystectomy
Secondary outcomes:
measure: Length of Stay Following Radical Cystectomy
timeFrame: duration of hospital stay. Days to weeks
measure: Patient Self-assessed Pain on Numerical Pain Scale
timeFrame: Up to 48 hours post-radical cystectomy
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Jonathan Wright
role: PRINCIPAL_INVESTIGATOR
References: