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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05388929
Other study ID # 1913843
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


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
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