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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-22

Study Completion Date

2019-02-28

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.

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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.

Conditions

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Bladder Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm I (gabapentin)

Patients receive gabapentin PO TID for 48 hours after surgery.

Group Type EXPERIMENTAL

Gabapentin

Intervention Type DRUG

Given PO

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Arm II (placebo)

Patients receive placebo PO TID for 48 hours after surgery.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Given PO

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Gabapentin

Given PO

Intervention Type DRUG

Placebo

Given PO

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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Gralise Neurontin placebo therapy PLCB sham therapy

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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No