Methocarbamol in Ventral and Inguinal HR

Inguinal Hernia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05388929
• Other study ID #: 1913843
• Status: Recruiting
• Phase: Phase 4
• Start date: June 23, 2022
• Est. completion date: May 2025

Study information

• Verified date: January 2024
• Source: Prisma Health-Upstate
• Contact: Jeremy A Warren, MD
• Phone: (864) 522-2100
• Email: jeremy.warren[@]prismahealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: May 2025
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Hernia, Ventral
• Inguinal Hernia
• Ventral Hernia

Intervention

Drug:
• Methocarbamol
Methocarbamol after surgery
• Standard Opioid
Standard opioid after surgery or at discharge
• Standard opioid plus methocarbamol
Standard opioid plus methocarbamol after surgery or at discharge

Locations

Country	Name	City	State
United States	Prisma Health	Greenville	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Prisma Health-Upstate

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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