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Muscle Relaxant

Methocarbamol + Opioids for Hernia Pain Management

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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days post surgery
Awards & highlights

Study Summary

This trial will compare the standard postoperative care for pain management, which includes opioids, to the addition of the drug methocarbamol.

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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Average total morphine milligram equivalents (MME) consumption
Proportion of patients requiring a rescue opioid prescription
Secondary outcome measures
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
3%
Sedation
3%
Respiratory Failure
3%
Hallucinations
1%
Delirium
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ketamine Infusion
Placebo Infusion

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

Find a Location

Who is running the clinical trial?

Prisma Health-UpstateLead Sponsor
83 Previous Clinical Trials
42,828 Total Patients Enrolled
Jeremy A Warren, MDPrincipal InvestigatorPrisma Health
1 Previous Clinical Trials
100 Total Patients Enrolled

Media Library

Methocarbamol (Muscle Relaxant) Clinical Trial Eligibility Overview. Trial Name: NCT05388929 — Phase 4
Ventral Hernia Research Study Groups: open or robotic ventral hernia repair outpatient, primary ventral hernia repair or inguinal hernia repair, open or robotic hernia repair inpatient
Ventral Hernia Clinical Trial 2023: Methocarbamol Highlights & Side Effects. Trial Name: NCT05388929 — Phase 4
Methocarbamol (Muscle Relaxant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05388929 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is Methocarbamol a reasonable pharmaceutical treatment for patients with no adverse effects?

"After analyzing the data, our team at Power rated Methocarbamol's safety a 3 since it is already approved as a treatment and this trial is in its fourth phase."

Answered by AI

What is the upper limit for participant enrollment in this research project?

"Affirmative. According to information available on clinicaltrials.gov, this medical trial is presently open for recruitment, having first been posted on June 23rd 2022 and last updated on August 8th 2022. The team plans to enrol a total of 120 patients at one site."

Answered by AI

Is the enrollment period for this trial still ongoing?

"According to clinicaltrials.gov, this specific medical trial is actively recruiting participants and has been since its inception on June 23rd 2022. The study's information was last revised on August 8th of the same year."

Answered by AI

Who else is applying?

What state do they live in?
South Carolina
What site did they apply to?
Prisma Health
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Methocarbamol in Ventral and Inguinal HR
2022. "Methocarbamol in Ventral and Inguinal HR". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05388929.
All > Hernia
~71 spots leftby May 2025
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