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

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


  • Org Study ID: 9274
  • Secondary ID: NCI-2015-00083,9274,P30CA015704
  • NCT ID: NCT02355886
  • NCT Alias:
  • Sponsor: University of Washington - Other
  • Source: University of Washington

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.

Overal Status Start Date Phase Study Type
Recruiting April 22, 2015 Phase 2/Phase 3 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Patient total equivalent analgesic requirement (morphine equivalents)

Primary Outcome 1 - Time Frame: 48 hours post-radical cystectomy

Condition:

  • Bladder Carcinoma

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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Gender: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Healthy Volunteers: No

Official Information

Name: Jonathan Wright

Role: Principal Investigator

Affiliation: Fred Hutch/University of Washington Cancer Consortium

Location

Facility Status Contact
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington 98109
United States
Recruiting George R. Schade

grschade@uw.edu