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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Bladder Carcinoma

Intervention / Treatment
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* Drug: Gabapentin
* Other: Placebo
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (gabapentin)<br>Patients receive gabapentin PO TID for 48 hours after surgery. | Drug: Gabapentin<br>* Given PO<br>* Other names: Neurontin;Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Placebo Comparator: Arm II (placebo)<br>Patients receive placebo PO TID for 48 hours after surgery. | Other: Placebo<br>* Given PO<br>* Other names: sham therapy;Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Total Equivalent Analgesic Requirement (Morphine Equivalents) | Geometric Mean and Standard Deviation of patient total equivalent analgesic | 48 hours post-radical cystectomy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |