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Preoperative Gabapentin vs Placebo for Vaginal Prolapse Surgery

Primary Purpose

Pelvic Organ Prolapse, Perioperative/Postoperative Complications

Status
Enrolling by invitation
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Gabapentin
Gabapentin Placebo
Sponsored by
Joseph Kowalski
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pelvic Organ Prolapse focused on measuring perioperative pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Scheduled for a vaginal apical support procedure (sacrospinous ligament fixation or vaginal uterosacral ligament suspension) Female Age 18 or higher Exclusion Criteria: Non-English speaking Incarcerated Cognitive impairment precluding informed consent Chronic opioid user Chronic gabapentinoid user Contraindication to acetaminophen, celecoxib, or gabapentinoids Concurrent laparoscopic or abdominal surgery

Sites / Locations

  • University of Iowa

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Intervention

Arm Description

Preoperative tylenol, preoperative celecoxib, preoperative gabapentin placebo

Preoperative tylenol, preoperative celecoxib, preoperative gabapentin

Outcomes

Primary Outcome Measures

Postoperative opioid use
Total postoperative opioid use in the first 24 hours postop measured in MME (starting when the patient leaves the operating room)

Secondary Outcome Measures

Mean postoperative pain score
Mean postoperative pain score (using the validated numerical rating scale, minimum score 0, maximum score 10, higher scores mean worse pain/worse outcome) while admitted
postoperative opioid use
postoperative opioid use while admitted
Time to discharge
Time (in hours) to discharge after surgery
Anti-emetic use
Postoperative anti-emetic use
Number of patients that had an adverse event
Adverse events
Number of patients who report postoperative dizziness
Patient reported postoperative dizziness
Number of patients who report sedation
Patient reported sedation
Number of patients who report visual changes
Patient reported visual changes
Number of patients who report postoperative nausea and vomiting
Patient reported postoperative nausea and vomiting
Number of patients who report postoperative pain adequacy
Patient reported postoperative pain adequacy

Full Information

First Posted
December 9, 2022
Last Updated
May 8, 2023
Sponsor
Joseph Kowalski
Collaborators
University of Iowa
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1. Study Identification

Unique Protocol Identification Number
NCT05658887
Brief Title
Preoperative Gabapentin vs Placebo for Vaginal Prolapse Surgery
Official Title
A Double-Blind Randomized Placebo-Controlled Clinical Trial of Preoperative Gabapentin Prior to Vaginal Apical Suspension Prolapse Procedures
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Joseph Kowalski
Collaborators
University of Iowa

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
This study will recruit women scheduled to undergo vaginal apical suspension surgery (either uterosacral ligament suspension or sacrospinous ligament fixation) with or without other prolapse or anti-incontinence procedures. Participants will be randomized 1:1 to preoperative gabapentin or preoperative placebo (both patients and investigators will be blinded). Note the control group will receive preoperative acetaminophen/celecoxib/placebo and the treatment group will receive preoperative acetaminophen/celecoxib/gabapentin (preoperative acetaminophen/celecoxib are part of our current ERAS protocol). The primary outcome will be postoperative opioid use in the first 24 hours postoperatively measured in morphine milligram equivalents.
Detailed Description
Enhanced Recovery after Surgery (ERAS) is an approach to perioperative care that focuses on evidence-based care protocols that emphasize minimizing stress and improving the body's response to stress. These protocols have resulted in a significant decrease in length of stay, complications, and cost in many different surgical specialities. Many of these protocols (including our current gynecology ERAS protocol) include preoperative gabapentin as an intervention to help reduce postoperative pain and postoperative opioid use. Gabapentin is an anticonvulsant medication that is commonly used for chronic neuropathic pain and other chronic pain disorders. The data regarding perioperative use of gabapentin is currently mixed, and the data in gynecology (and especially urogynecology) is limited. Notably gabapentin has been shown to be associated with sedation, respiratory depression, dizziness, and visual disturbances. In 2019, the U.S. Food and Drug Administration issued a warning that serious breathing difficulties may occur in patients using gabapentin with respiratory risk factors. Pelvic organ prolapse is a common benign condition, and surgery for pelvic organ prolapse is very common. Vaginal apical suspension is one of the most common surgeries for pelvic organ prolapse. There is very limited data on the utility of preoperative gabapentin for vaginal apical suspension surgery. This study will recruit women scheduled to undergo vaginal apical suspension surgery (either uterosacral ligament suspension or sacrospinous ligament fixation) with or without other prolapse or anti-incontinence procedures. Participants will be randomized 1:1 to preoperative gabapentin or preoperative placebo (both patients and investigators will be blinded). Note the control group will receive preoperative acetaminophen/celecoxib/placebo and the treatment group will receive preoperative acetaminophen/celecoxib/gabapentin (preoperative acetaminophen/celecoxib are part of our current ERAS protocol). The primary outcome will be postoperative opioid use in the first 24 hours postoperatively measured in morphine milligram equivalents.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse, Perioperative/Postoperative Complications
Keywords
perioperative pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Preoperative tylenol, preoperative celecoxib, preoperative gabapentin placebo
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Preoperative tylenol, preoperative celecoxib, preoperative gabapentin
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Other Intervention Name(s)
FusePaq Fanatrex, Gabarone, Gralise, Neurontin
Intervention Description
One dose of preoperative gabapentin 300 mg prior to vaginal apical support procedure
Intervention Type
Drug
Intervention Name(s)
Gabapentin Placebo
Other Intervention Name(s)
FusePaq Fanatrex Placebo, Gabarone Placebo, Gralise Placebo, Neurontin Placebo
Intervention Description
Gabapentin Placebo
Primary Outcome Measure Information:
Title
Postoperative opioid use
Description
Total postoperative opioid use in the first 24 hours postop measured in MME (starting when the patient leaves the operating room)
Time Frame
24 hours after surgery
Secondary Outcome Measure Information:
Title
Mean postoperative pain score
Description
Mean postoperative pain score (using the validated numerical rating scale, minimum score 0, maximum score 10, higher scores mean worse pain/worse outcome) while admitted
Time Frame
After surgery, max of 24 hours
Title
postoperative opioid use
Description
postoperative opioid use while admitted
Time Frame
After surgery, max of 24 hours
Title
Time to discharge
Description
Time (in hours) to discharge after surgery
Time Frame
After surgery, at the time the patient is discharged
Title
Anti-emetic use
Description
Postoperative anti-emetic use
Time Frame
After surgery, max of 24 hours
Title
Number of patients that had an adverse event
Description
Adverse events
Time Frame
After surgery until 24 hours postoperative
Title
Number of patients who report postoperative dizziness
Description
Patient reported postoperative dizziness
Time Frame
24 hours postoperative
Title
Number of patients who report sedation
Description
Patient reported sedation
Time Frame
24 hours postoperative
Title
Number of patients who report visual changes
Description
Patient reported visual changes
Time Frame
24 hours postoperative
Title
Number of patients who report postoperative nausea and vomiting
Description
Patient reported postoperative nausea and vomiting
Time Frame
24 hours postoperative
Title
Number of patients who report postoperative pain adequacy
Description
Patient reported postoperative pain adequacy
Time Frame
24 hours postoperative

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Scheduled for a vaginal apical support procedure (sacrospinous ligament fixation or vaginal uterosacral ligament suspension) Female Age 18 or higher Exclusion Criteria: Non-English speaking Incarcerated Cognitive impairment precluding informed consent Chronic opioid user Chronic gabapentinoid user Contraindication to acetaminophen, celecoxib, or gabapentinoids Concurrent laparoscopic or abdominal surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Kowalski, MD
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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Preoperative Gabapentin vs Placebo for Vaginal Prolapse Surgery

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