What side effects are associated with this type of intervention?

Common treatments for ventral hernia include methocarbamol and opioids. Methocarbamol, a muscle relaxant, can cause side effects such as dizziness, drowsiness, nausea, and headache. Opioids, often used for pain management, can lead to constipation, nausea, vomiting, drowsiness, and the risk of dependency. Combining methocarbamol with opioids may enhance pain relief but also increases the likelihood of experiencing these side effects.

What prior FDA approvals exist?

The FDA has approved various treatments for ventral hernia, primarily focusing on surgical interventions such as hernia repair using mesh implants. Pain management post-surgery often involves the use of standard opioids and non-opioid analgesics. Methocarbamol, a muscle relaxant that blocks nerve impulses to reduce pain, is being studied for its efficacy in managing postoperative pain in ventral hernia repair. While methocarbamol itself may not have a specific FDA approval for ventral hernia, it is commonly used off-label for muscle relaxation and pain relief in similar surgical contexts.

What other types of research exist?

Promising alternatives to Methocarbamol for ventral hernia patients include: 1) Transversus Abdominis Plane Block (TAPb) with liposomal bupivacaine, which provides prolonged analgesic effects up to 72 hours. 2) Caudal epidural administration of bupivacaine combined with additives like ketamine, midazolam, or neostigmine, which have been shown to enhance pain relief. 3) Neuraxial anesthesia techniques, such as spinal or epidural anesthesia, which can offer effective pain management with potentially fewer side effects compared to systemic muscle relaxants.

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Muscle Relaxant

Methocarbamol + Opioids for Hernia Pain Management

Q: What is the mechanism of action of this treatment?

The most common treatments for ventral hernia, particularly those studied in trials like methocarbamol, include muscle relaxants and opioids. Methocarbamol works by blocking nerve impulses to reduce pain and muscle spasms, while opioids bind to receptors in the brain and spinal cord to block pain signals and alter pain perception. Effective pain management is essential for ventral hernia patients as it enhances comfort, accelerates recovery, and minimizes the risk of complications such as chronic pain or reduced mobility.

Phase 4

Recruiting

Led By Jeremy A Warren, MD

Research Sponsored by Prisma Health-Upstate

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients undergoing open incisional hernia repair (group 3)

Patients undergoing open primary ventral hernia repair (group 1)

Must not have

Patients <18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days post surgery

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial is studying methocarbamol, a muscle relaxant, for pain management in patients having ventral or inguinal hernia surgery. Methocarbamol has been used since 1994 as an adjunct for pain management in various surgeries, showing a decrease in postoperative pain and use of intravenous narcotics. The study will compare methocarbamol alone, standard opioid treatment, and a combination of both. The goal is to find out if methocarbamol can effectively reduce pain after surgery.

Who is the study for?

Adults over 18 undergoing ventral or inguinal hernia repair who consent to randomization can join this trial. It's not for those under 18, pregnant individuals, or chronic opioid users.

What is being tested?

The study is testing methocarbamol as a pain treatment after hernia surgery. Participants will either receive standard opioids alone, methocarbamol alone, or both together in different groups based on the type of surgery they have.

What are the potential side effects?

Methocarbamol may cause dizziness, headache, feverish feelings, nausea, vomiting and blurred vision. Standard opioids can lead to constipation, nausea, sleepiness and potential dependency.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am having an open incisional hernia repair.

Select...

I am having an open surgery for a primary ventral hernia.

Select...

I am having robotic surgery for a hernia in my abdomen.

Select...

I am having surgery for an inguinal hernia.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am under 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days post surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days post surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days post surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Average total morphine milligram equivalents (MME) consumption

Proportion of patients requiring a rescue opioid prescription

Secondary study objectives

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

Visual Analog Scale pain scores

Side effects data

From 2018 Phase 4 trial • 153 Patients • NCT02432456

Respiratory Failure

Sedation

Hallucinations

Delirium

100%

80%

60%

40%

20%

Study treatment Arm

Ketamine Infusion

Placebo Infusion

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Experimental Treatment

Group I: primary ventral hernia repair or inguinal hernia repairExperimental Treatment2 Interventions

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

Group II: open or robotic ventral hernia repair outpatientExperimental Treatment2 Interventions

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

Group III: open or robotic hernia repair inpatientExperimental Treatment2 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Methocarbamol

2016

Completed Phase 4

~480

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for ventral hernia, particularly those studied in trials like methocarbamol, include muscle relaxants and opioids. Methocarbamol works by blocking nerve impulses to reduce pain and muscle spasms, while opioids bind to receptors in the brain and spinal cord to block pain signals and alter pain perception. Effective pain management is essential for ventral hernia patients as it enhances comfort, accelerates recovery, and minimizes the risk of complications such as chronic pain or reduced mobility.

[Postoperative management after cesarean section--infusion therapy and role of intestinal stimulation with parasympathomimetic drugs and dexpanthenon].Midazolam for caudal analgesia in children: comparison with caudal bupivacaine.Rhomboid Intercostal and Serratus Anterior Interfascial Plane Blocks for the Treatment of Post-Operative Pain after Video-Assisted Thoracoscopic Surgery: A Retrospective Propensity-Matched Study.