Back to resultsEffect of Perioperative Gabapentin on Postoperative Opioid Requirements
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Preoperative Gabapentin/Postoperative Placebo
Preoperative Gabapentin/Postoperative Gabapentin
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain
Eligibility Criteria
Inclusion Criteria:
- Women > 18 years old
- English-speaking
- Stage > 2 pelvic organ prolapse
- Undergoing pelvic organ prolapse procedure (including native tissue vaginal procedure, native tissue laparoscopic procedure, mesh-augmented laparoscopic procedure, obliterative procedure)
- Planning overnight stay
Exclusion Criteria:
- Renal dysfunction (creatinine clearance <60 mL/min)
- Allergy to acetaminophen and ibuprofen
- Allergy to gabapentin
- Patients on a Controlled Substance Agreement or Opioid Contract from another provider. This information is available in the IU Health electronic medical record, Cerner.
Sites / Locations
- Indiana University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Preoperative Gabapentin/Postoperative Placebo
Preoperative Gabapentin/Postoperative Gabapentin
Arm Description
Outcomes
Primary Outcome Measures
Opioid Prescription at Discharge
Percentage of patients requiring an opioid prescription at discharge in each group. Patients who use 5 or more doses of PRN opioids during inpatient postoperative course will receive a prescription for opioids.
Secondary Outcome Measures
Opioid Refill Requests
Number of patients in each group who call the office to request a new opioid prescription (if they were discharged without a prescription) or to request an opioid prescription refill (if they were discharged with a prescription) within the 6-week postoperative time period.
Inpatient Pain Scores
Pain scores in the hospital will be measured on a numeric rating scale (0-10) with 0 being no pain and 10 being worst pain. Pain score collected will be pain recorded at 12 hours after arrival to the floor and highest score during hospital stay
Inpatient Morphine Milligram Equivalents
Total morphine milligram equivalents used will be calculated by converting total PO and IV opioids used postoperatively until hospital discharge to morphine milligram equivalents using the opioid equianalgesic chart.
Length of Stay
Length of stay will be measured in hours by time of registration for surgery to time of discharge from hospital.
Nausea
Nausea will be measured by the number of "as needed" antiemetics the patient received postoperatively.
Sedation
Sedation will be measured by the Stanford Sleepiness Scale. This is a self-administered scale that the patient will complete at 10AM on postoperative day 1.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05494385
Brief Title
Effect of Perioperative Gabapentin on Postoperative Opioid Requirements
Official Title
Effect of Perioperative Gabapentin on Postoperative Opioid Requirements
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
July 27, 2021 (Actual)
Primary Completion Date
June 17, 2023 (Actual)
Study Completion Date
July 5, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine if preoperative gabapentin is noninferior to preoperative and postoperative gabapentin for pain control in patients undergoing surgery for pelvic organ prolapse.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
132 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Preoperative Gabapentin/Postoperative Placebo
Arm Type
Placebo Comparator
Arm Title
Preoperative Gabapentin/Postoperative Gabapentin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Preoperative Gabapentin/Postoperative Placebo
Intervention Description
Postoperatively, this group will receive scheduled acetaminophen and ibuprofen every 6 hours, in addition to placebo every 12 hours. The placebo is encapsulated to appear identical to the active drug. This group will have oxycodone 5 mg every 6 hours as needed for pain.
Intervention Type
Drug
Intervention Name(s)
Preoperative Gabapentin/Postoperative Gabapentin
Intervention Description
Postoperatively, this group will receive scheduled acetaminophen and ibuprofen every 6 hours, in addition to gabapentin every 12 hours. The gabapentin is encapsulated to appear identical to the placebo. This group will have oxycodone 5 mg every 6 hours as needed for pain.
Primary Outcome Measure Information:
Title
Opioid Prescription at Discharge
Description
Percentage of patients requiring an opioid prescription at discharge in each group. Patients who use 5 or more doses of PRN opioids during inpatient postoperative course will receive a prescription for opioids.
Time Frame
Length of postoperative hospital stay (typically less than 48 hours)
Secondary Outcome Measure Information:
Title
Opioid Refill Requests
Description
Number of patients in each group who call the office to request a new opioid prescription (if they were discharged without a prescription) or to request an opioid prescription refill (if they were discharged with a prescription) within the 6-week postoperative time period.
Time Frame
6 weeks
Title
Inpatient Pain Scores
Description
Pain scores in the hospital will be measured on a numeric rating scale (0-10) with 0 being no pain and 10 being worst pain. Pain score collected will be pain recorded at 12 hours after arrival to the floor and highest score during hospital stay
Time Frame
Length of postoperative hospital stay (typically less than 48 hours)
Title
Inpatient Morphine Milligram Equivalents
Description
Total morphine milligram equivalents used will be calculated by converting total PO and IV opioids used postoperatively until hospital discharge to morphine milligram equivalents using the opioid equianalgesic chart.
Time Frame
Length of postoperative hospital stay (typically less than 48 hours)
Title
Length of Stay
Description
Length of stay will be measured in hours by time of registration for surgery to time of discharge from hospital.
Time Frame
Length of postoperative hospital stay (typically less than 48 hours)
Title
Nausea
Description
Nausea will be measured by the number of "as needed" antiemetics the patient received postoperatively.
Time Frame
Length of postoperative hospital stay (typically less than 48 hours)
Title
Sedation
Description
Sedation will be measured by the Stanford Sleepiness Scale. This is a self-administered scale that the patient will complete at 10AM on postoperative day 1.
Time Frame
Length of postoperative hospital stay (typically less than 48 hours)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women > 18 years old
English-speaking
Stage > 2 pelvic organ prolapse
Undergoing pelvic organ prolapse procedure (including native tissue vaginal procedure, native tissue laparoscopic procedure, mesh-augmented laparoscopic procedure, obliterative procedure)
Planning overnight stay
Exclusion Criteria:
Renal dysfunction (creatinine clearance <60 mL/min)
Allergy to acetaminophen and ibuprofen
Allergy to gabapentin
Patients on a Controlled Substance Agreement or Opioid Contract from another provider. This information is available in the IU Health electronic medical record, Cerner.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Douglass S Hale, MD
Organizational Affiliation
Indiana University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University School of Medicine
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Perioperative Gabapentin on Postoperative Opioid Requirements
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