Methocarbamol in Ventral and Inguinal HR

NCT05388929 | Active Not Recruiting Phase 4 FDA Drug

• 1 other identifier: 1913843
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventral Hernia; Inguinal Hernia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• European Registry of Abdominal Wall Hernias (EuraHS) Quality of Life tool scores

  30 days post surgery

• Visual Analog Scale pain scores

  7 days post surgery

Study Arms (3)

primary ventral hernia repair or inguinal hernia repair

EXPERIMENTAL

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

Drug: Methocarbamol; Drug: Standard Opioid

open or robotic ventral hernia repair outpatient

EXPERIMENTAL

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

Drug: Standard Opioid; Drug: Standard opioid plus methocarbamol

open or robotic hernia repair inpatient

EXPERIMENTAL

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

Drug: Standard Opioid; Drug: Standard opioid plus methocarbamol

Interventions

Methocarbamol DRUG

Methocarbamol after surgery

primary ventral hernia repair or inguinal hernia repair

Standard Opioid DRUG

Standard opioid after surgery or at discharge

open or robotic hernia repair inpatient; open or robotic ventral hernia repair outpatient; primary ventral hernia repair or inguinal hernia repair

Standard opioid plus methocarbamol DRUG

Standard opioid plus methocarbamol after surgery or at discharge

open or robotic hernia repair inpatient; open or robotic ventral hernia repair outpatient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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

You may not qualify if:

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

Sponsors & Collaborators

• Prisma Health-Upstate: lead

Study Sites (1)

Prisma Health

Greenville, South Carolina, 29615, United States

Location

MeSH Terms

Conditions

Hernia, Ventral; Hernia, Inguinal

Interventions

Methocarbamol

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylcarbamates; Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Guaifenesin; Guaiacol; Methyl Ethers; Ethers; Phenyl Ethers; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Jeremy A Warren, MD

  Prisma Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2022
• First Posted: May 24, 2022
• Study Start: June 23, 2022
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)