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

Primary Purpose

Bladder Carcinoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Gabapentin
Placebo
Questionnaire Administration
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Bladder Carcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Fred Hutch/University of Washington Cancer Consortium

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm I (gabapentin)

Arm II (placebo)

Arm Description

Patients receive gabapentin PO TID for 48 hours after surgery.

Patients receive placebo PO TID for 48 hours after surgery.

Outcomes

Primary Outcome Measures

Patient Total Equivalent Analgesic Requirement (Morphine Equivalents)
Geometric Mean and Standard Deviation of patient total equivalent analgesic

Secondary Outcome Measures

Length of Stay Following Radical Cystectomy
The two study groups will be compared by Length of stay following radical cystectomy
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.

Full Information

First Posted
January 30, 2015
Last Updated
May 13, 2019
Sponsor
University of Washington
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02355886
Brief Title
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

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
April 22, 2015 (Actual)
Primary Completion Date
February 28, 2018 (Actual)
Study Completion Date
February 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Washington
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Carcinoma

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I (gabapentin)
Arm Type
Experimental
Arm Description
Patients receive gabapentin PO TID for 48 hours after surgery.
Arm Title
Arm II (placebo)
Arm Type
Placebo Comparator
Arm Description
Patients receive placebo PO TID for 48 hours after surgery.
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Other Intervention Name(s)
Gralise, Neurontin
Intervention Description
Given PO
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
placebo therapy, PLCB, sham therapy
Intervention Description
Given PO
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Patient Total Equivalent Analgesic Requirement (Morphine Equivalents)
Description
Geometric Mean and Standard Deviation of patient total equivalent analgesic
Time Frame
48 hours post-radical cystectomy
Secondary Outcome Measure Information:
Title
Length of Stay Following Radical Cystectomy
Description
The two study groups will be compared by Length of stay following radical cystectomy
Time Frame
duration of hospital stay. Days to weeks
Title
Patient Self-assessed Pain on Numerical Pain Scale
Description
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.
Time Frame
Up to 48 hours post-radical cystectomy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Wright
Organizational Affiliation
Fred Hutch/University of Washington Cancer Consortium
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fred Hutch/University of Washington Cancer Consortium
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States

12. IPD Sharing Statement

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

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