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Completed

NCT Number: NCT02355886

Gabapentin in Reducing the Need for Pain Medication in Patients With Bladder Cancer 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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Gabapentin

Drug

Given PO

Other names: Gralise, Neurontin

Placebo

Other

Given PO

Other names: placebo therapy, PLCB, sham therapy

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. Patient Total Equivalent Analgesic Requirement (Morphine Equivalents)

    Time frame: 48 hours post-radical cystectomy

    Geometric Mean and Standard Deviation of patient total equivalent analgesic

Secondary outcomes

  1. Length of Stay Following Radical Cystectomy

    Time frame: duration of hospital stay. Days to weeks

    The two study groups will be compared by Length of stay following radical cystectomy

  2. Patient Self-assessed Pain on Numerical Pain Scale

    Time frame: Up to 48 hours post-radical cystectomy

    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.

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
Feb 4, 2015
Registry last updated
Jun 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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