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Methocarbamol in Ventral and Inguinal HR

Primary Purpose

Ventral Hernia, Inguinal Hernia

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Methocarbamol
Standard Opioid
Standard opioid plus methocarbamol
Sponsored by
Prisma Health-Upstate
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ventral Hernia

Eligibility Criteria

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

Inclusion Criteria:

  • >18 y/o
  • Patients undergoing open primary ventral hernia repair (group 1)
  • Patients undergoing inguinal hernia repair (open, laparoscopic, or robotic; group 2)
  • Patients undergoing open incisional hernia repair (group 3)
  • Robotic repair ventral or incisional hernias (group 4)
  • Given consent for randomization

Exclusion Criteria:

  • <18 y/o
  • Pregnancy
  • Chronic opioid users

Sites / Locations

  • Prisma HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

primary ventral hernia repair or inguinal hernia repair

open or robotic ventral hernia repair outpatient

open or robotic hernia repair inpatient

Arm Description

Primary ventral hernias, including umbilical, epigastric, and Spigelian hernias. Primary or recurrent inguinal hernias.

Open repair of ventral incisional hernias. Robotic repair of ventral primary or incisional hernias.

Open repair of ventral incisional hernias. Robotic repair of ventral primary or incisional hernias.

Outcomes

Primary Outcome Measures

Proportion of patients requiring a rescue opioid prescription
The proportion of patients requiring a rescue opioid prescription will be compared between the study and control groups using the Fisher's Exact Test (bivariate analysis). Multiple logistic regression analysis will then be used to test for a difference in this outcome, adjusting for any baseline differences between the 2 study groups.
Average total morphine milligram equivalents (MME) consumption
Average total MME consumption will be compared between the study and control groups using either the Student's T-test or the Wilcoxon Rank Sum Test (depends on distribution of the data -- parametric vs. non-parametric).

Secondary Outcome Measures

European Registry of Abdominal Wall Hernias (EuraHS) Quality of Life tool scores
Scale of 0-10, where 0 = no pain and 10 = worst pain imaginable. Outcome will be compared between the study and control groups using either the Student's T-test or the Wilcoxon Rank Sum Test. Statistical tests used are dependent on the data distribution -- parametric vs. non-parametric).
Visual Analog Scale pain scores
Scale of 0-10, where 0 = no pain and 10 = worst pain imaginable. Outcome will be compared between the study and control groups using either the Student's T-test or the Wilcoxon Rank Sum Test. Statistical tests used are dependent on the data distribution -- parametric vs. non-parametric).

Full Information

First Posted
May 19, 2022
Last Updated
July 13, 2023
Sponsor
Prisma Health-Upstate
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1. Study Identification

Unique Protocol Identification Number
NCT05388929
Brief Title
Methocarbamol in Ventral and Inguinal HR
Official Title
Addition of Methocarbamol to Postoperative Multimodal Analgesic Regimen: A Prospective, Randomized Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 23, 2022 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Prisma Health-Upstate

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.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to gather information on methocarbamol as a pain management treatment for ventral or inguinal hernia repair. Methocarbamol has been part of the pain management treatment for both inpatient and outpatient procedures at Prisma Health. This study will compare the outcomes of patients who receive methocarbamol, those who receive the standard opioid pain management treatment, and those who receive methocarbamol plus the standard opioid pain management treatment. Participants will be randomized into one of the study groups listed below. Primary ventral hernia repair or inguinal hernia repair: Group 1: standard opioid after surgery Group 2: methocarbamol after surgery Open or robotic ventral hernia repair outpatient: Group 1: standard opioid after surgery Group 2: standard opioid plus methocarbamol after surgery Open or robotic ventral hernia repair inpatient: Group 1: standard opioid at discharge Group 2: standard opioid plus methocarbamol at discharge A total of 120 participants will be included in the study. Participation will last for about 30 days after surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventral Hernia, Inguinal Hernia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
primary ventral hernia repair or inguinal hernia repair
Arm Type
Experimental
Arm Description
Primary ventral hernias, including umbilical, epigastric, and Spigelian hernias. Primary or recurrent inguinal hernias.
Arm Title
open or robotic ventral hernia repair outpatient
Arm Type
Experimental
Arm Description
Open repair of ventral incisional hernias. Robotic repair of ventral primary or incisional hernias.
Arm Title
open or robotic hernia repair inpatient
Arm Type
Experimental
Arm Description
Open repair of ventral incisional hernias. Robotic repair of ventral primary or incisional hernias.
Intervention Type
Drug
Intervention Name(s)
Methocarbamol
Intervention Description
Methocarbamol after surgery
Intervention Type
Drug
Intervention Name(s)
Standard Opioid
Intervention Description
Standard opioid after surgery or at discharge
Intervention Type
Drug
Intervention Name(s)
Standard opioid plus methocarbamol
Intervention Description
Standard opioid plus methocarbamol after surgery or at discharge
Primary Outcome Measure Information:
Title
Proportion of patients requiring a rescue opioid prescription
Description
The proportion of patients requiring a rescue opioid prescription will be compared between the study and control groups using the Fisher's Exact Test (bivariate analysis). Multiple logistic regression analysis will then be used to test for a difference in this outcome, adjusting for any baseline differences between the 2 study groups.
Time Frame
30 days post surgery
Title
Average total morphine milligram equivalents (MME) consumption
Description
Average total MME consumption will be compared between the study and control groups using either the Student's T-test or the Wilcoxon Rank Sum Test (depends on distribution of the data -- parametric vs. non-parametric).
Time Frame
30 days post surgery
Secondary Outcome Measure Information:
Title
European Registry of Abdominal Wall Hernias (EuraHS) Quality of Life tool scores
Description
Scale of 0-10, where 0 = no pain and 10 = worst pain imaginable. Outcome will be compared between the study and control groups using either the Student's T-test or the Wilcoxon Rank Sum Test. Statistical tests used are dependent on the data distribution -- parametric vs. non-parametric).
Time Frame
30 days post surgery
Title
Visual Analog Scale pain scores
Description
Scale of 0-10, where 0 = no pain and 10 = worst pain imaginable. Outcome will be compared between the study and control groups using either the Student's T-test or the Wilcoxon Rank Sum Test. Statistical tests used are dependent on the data distribution -- parametric vs. non-parametric).
Time Frame
7 days post surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: >18 y/o Patients undergoing open primary ventral hernia repair (group 1) Patients undergoing inguinal hernia repair (open, laparoscopic, or robotic; group 2) Patients undergoing open incisional hernia repair (group 3) Robotic repair ventral or incisional hernias (group 4) Given consent for randomization Exclusion Criteria: <18 y/o Pregnancy Chronic opioid users
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeremy A Warren, MD
Phone
(864) 522-2100
Email
jeremy.warren@prismahealth.org
First Name & Middle Initial & Last Name or Official Title & Degree
Aimee N Hanvey, MS
Phone
864-797-6528
Email
aimee.hanvey@prismahealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeremy A Warren, MD
Organizational Affiliation
Prisma Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prisma Health
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeremy A Warren, MD
Phone
864-522-2100
Email
jeremy.warren@prismahealth.org

12. IPD Sharing Statement

Plan to Share IPD
No

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Methocarbamol in Ventral and Inguinal HR

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