Methocarbamol in Ventral and Inguinal HR

Study Overview
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Brief Summary
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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 120 participants will be included in the study. Participation will last for about 30 days after surgery.

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

Conditions
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Ventral Hernia, Inguinal Hernia

Intervention / Treatment
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* Drug: Methocarbamol
* Drug: Standard Opioid
* Drug: Standard opioid plus methocarbamol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |