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NCT Number: NCT05388929

Methocarbamol in Ventral and Inguinal HR

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Ventral Hernia Hernia Hernia, Abdominal Hernia, Inguinal Hernia, Ventral Inguinal Hernia Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Prisma Health

Greenville, South Carolina, 29615, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Methocarbamol

Drug

Methocarbamol after surgery

Standard Opioid

Drug

Standard opioid after surgery or at discharge

Standard opioid plus methocarbamol

Drug

Standard opioid plus methocarbamol after surgery or at discharge

Primary outcomes

  1. Proportion of patients requiring a rescue opioid prescription

    Time frame: 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.

  2. Average total morphine milligram equivalents (MME) consumption

    Time frame: 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 outcomes

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

    Time frame: 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).

  2. Visual Analog Scale pain scores

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Prisma Health-Upstate

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
May 24, 2022
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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