Methocarbamol in Ventral and Inguinal HR

Phase 4

Active, not recruiting

• Conditions: Inguinal Hernia; Ventral Hernia
• Interventions: Drug: Methocarbamol; Drug: Standard Opioid; Drug: Standard opioid plus methocarbamol

• Registration Number: NCT05388929
• Lead Sponsor: Prisma Health-Upstate

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 200 participants will be included in the study.

Participation will last for about 30 days after surgery.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-19
• Study First Submitted QC: 2022-05-19
• Study First Posted: 2022-05-24
• Study Start: 2022-06-23
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-02
• Primary Completion: 2025-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 164

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
primary ventral hernia repair or inguinal hernia repair	Standard Opioid	Primary ventral hernias, including umbilical, epigastric, and Spigelian hernias. Primary or recurrent inguinal hernias.
open or robotic ventral hernia repair outpatient	Standard Opioid	Open repair of ventral incisional hernias. Robotic repair of ventral primary or incisional hernias.
open or robotic ventral hernia repair outpatient	Standard opioid plus methocarbamol	Open repair of ventral incisional hernias. Robotic repair of ventral primary or incisional hernias.
open or robotic hernia repair inpatient	Standard Opioid	Open repair of ventral incisional hernias. Robotic repair of ventral primary or incisional hernias.
open or robotic hernia repair inpatient	Standard opioid plus methocarbamol	Open repair of ventral incisional hernias. Robotic repair of ventral primary or incisional hernias.
primary ventral hernia repair or inguinal hernia repair	Methocarbamol	Primary ventral hernias, including umbilical, epigastric, and Spigelian hernias. Primary or recurrent inguinal hernias.

Primary Outcome Measures

Name	Time	Method
Proportion of patients requiring a rescue opioid prescription	30 days post surgery	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	30 days post surgery	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

Name	Time	Method
European Registry of Abdominal Wall Hernias (EuraHS) Quality of Life tool scores	30 days post surgery	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	7 days post surgery	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).

Trial Locations

Locations (1)

Prisma Health; 🇺🇸 Greenville, South Carolina, United States