Methocarbamol in Ventral and Inguinal HR

Addition of Methocarbamol to Postoperative Multimodal Analgesic Regimen: A Prospective, Randomized Pilot Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Inguinal Hernia; Ventral Hernia
• Intervention / Treatment: Drug: Methocarbamol; Drug: Standard Opioid; Drug: Standard opioid plus methocarbamol

• Study Type: Interventional
• Enrollment (Actual): 164
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Greenville, South Carolina, United States, 29615
      • Prisma Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: primary ventral hernia repair or inguinal hernia repair; Primary ventral hernias, including umbilical, epigastric, and Spigelian hernias. Primary or recurrent inguinal hernias.	Drug: Methocarbamol; Methocarbamol after surgery; Drug: Standard Opioid; Standard opioid after surgery or at discharge
Experimental: open or robotic ventral hernia repair outpatient; Open repair of ventral incisional hernias. Robotic repair of ventral primary or incisional hernias.	Drug: Standard Opioid; Standard opioid after surgery or at discharge; Drug: Standard opioid plus methocarbamol; Standard opioid plus methocarbamol after surgery or at discharge
Experimental: open or robotic hernia repair inpatient; Open repair of ventral incisional hernias. Robotic repair of ventral primary or incisional hernias.	Drug: Standard Opioid; Standard opioid after surgery or at discharge; Drug: Standard opioid plus methocarbamol; Standard opioid plus methocarbamol after surgery or at discharge

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30 days post surgery
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).	30 days post surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	30 days post surgery
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).	7 days post surgery

Collaborators and Investigators

• Sponsor: Prisma Health-Upstate
• Investigators: Principal Investigator: Jeremy A Warren, MD, Prisma Health

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2022
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: May 19, 2022
• First Submitted That Met QC Criteria: May 19, 2022
• First Posted (Actual): May 24, 2022

Study Record Updates

• Last Update Posted (Estimated): July 8, 2025
• Last Update Submitted That Met QC Criteria: July 3, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal; Hernia, Ventral; Physiological Effects of Drugs; Peripheral Nervous System Agents; Central Nervous System Depressants; Sensory System Agents; Analgesics; Narcotics; Neuromuscular Agents; Muscle Relaxants, Central; Analgesics, Opioid; Methocarbamol
• Other Study ID Numbers: 1913843

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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