Methocarbamol + Opioids for Hernia Pain Management

Overseen by Jeremy Warren, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: Prisma Health-Upstate

Must not be taking: Opioids

Disqualifiers: Pregnancy, Chronic opioid users, others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, chronic opioid users are excluded from participating, which suggests that ongoing opioid use might not be allowed.

Is the combination of Methocarbamol and opioids safe for managing hernia pain?

Opioids, while effective for pain management, can cause side effects like respiratory depression (slowed breathing) and gastrointestinal issues. These side effects are generally manageable with proper medical supervision. Methocarbamol, a muscle relaxant, is generally considered safe but should be used cautiously with opioids to avoid increased sedation. ^{1 2 3 4 5}

How does the drug combination of methocarbamol and opioids for hernia pain management differ from other treatments?

This treatment is unique because it combines methocarbamol, a muscle relaxant, with opioids to potentially reduce the amount of opioids needed for pain relief after hernia surgery, addressing the risk of opioid misuse. Unlike some other treatments that aim to eliminate opioids entirely, this approach uses methocarbamol to enhance pain management while still incorporating opioids. ^{6 7 8 9 10}

Research Team

Jeremy Warren, MD

Principal Investigator

Prisma Health

Eligibility Criteria

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.

Inclusion Criteria

I am older than 18 years.

I am having an open incisional hernia repair.

Patients who have given consent for randomization

Exclusion Criteria

Chronic opioid users

Pregnancy

I am under 18 years old.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive methocarbamol, standard opioid, or a combination after hernia repair surgery

30 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days

Treatment Details

Interventions

• Methocarbamol (Muscle Relaxant)
• Standard Opioid (Opioid Analgesic)

Trial Overview 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.

Participant Groups

Group I: primary ventral hernia repair or inguinal hernia repair Experimental Treatment 2 Interventions

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

Group II: open or robotic ventral hernia repair outpatient Experimental Treatment 2 Interventions

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

Group III: open or robotic hernia repair inpatient Experimental Treatment 2 Interventions

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

Methocarbamol is already approved in Canada for the following indications:

Approved in Canada as Methocarbamol for:

• Muscle spasms
• Pain management

Who Is Running the Clinical Trial?

Prisma Health-Upstate

Lead Sponsor

Trials

91

Recruited

47,500+

Mark S. O’Halla

Prisma Health-Upstate

Chief Executive Officer since 2019

MBA

Patrice M. Weiss

Prisma Health-Upstate

Chief Medical Officer

MD

Findings from Research

Oliceridine, a biased opioid agonist approved by the FDA, provides effective pain relief for moderate to severe acute pain, showing superior analgesia compared to placebo and equianalgesic effects to morphine without increasing respiratory complications, based on two Phase III trials involving patients after bunionectomy and abdominoplasty.

While initial studies suggest that Oliceridine may have a lower risk of opioid-induced respiratory depression and gastrointestinal issues compared to traditional opioids like morphine, further prospective studies are necessary to confirm its safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oliceridine: A Novel Drug for the Management of Moderate to Severe Acute Pain - A Review of Current Evidence. Tan, HS., Habib, AS.[2021]

Opioids can be effective and relatively safe options for managing pain, but they are often avoided due to concerns about potential side effects and adverse events.

The side effects of opioids can affect multiple body systems, but with proper management and quick intervention, these effects can be addressed, allowing opioids to be used safely and effectively for pain relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anticipating and treating opioid-associated adverse effects. Herndon, CM., Kalauokalani, DA., Cunningham, AJ., et al.[2019]

In patients with renal impairment, safer analgesic options include alfentanil, buprenorphine, and fentanyl, as they do not produce high levels of active metabolites or have prolonged clearance, making them suitable for managing acute pain.

For patients with hepatic impairment, remifentanil is the least affected by altered drug clearance, but caution is needed with other analgesics, as many require close monitoring and some, like methadone, are contraindicated in severe liver disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute pain management pharmacology for the patient with concurrent renal or hepatic disease. Murphy, EJ.[2019]

The review emphasizes that while analgesics, both non-opioid (like paracetamol and NSAIDs) and opioid medications, are commonly used for pain management, they carry significant risks of adverse drug reactions (ADRs) that can often be prevented.

Recognizing and understanding the safety issues associated with analgesics is crucial for healthcare professionals to ensure effective pain treatment while minimizing risks, highlighting the importance of careful patient monitoring and consideration of individual medical factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety issues of current analgesics: an update. Cazacu, I., Mogosan, C., Loghin, F.[2022]

Opioid-induced respiratory depression is a major risk associated with opioid use, primarily mediated by μ receptors in the central nervous system, which can lead to life-threatening conditions like cardiorespiratory arrest.

While opioids can cause histamine release, leading to hemodynamic changes, serious allergic reactions are rare, and the FDA has warned about the risk of serotonin syndrome when opioids are used with other serotonergic medications, highlighting the need for caution in prescribing practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toxicities of opioid analgesics: respiratory depression, histamine release, hemodynamic changes, hypersensitivity, serotonin toxicity. Baldo, BA.[2022]

In a study evaluating 13 analgesic drugs for postoperative pain relief, levorphanol 2 mg was found to be significantly more effective than the standard reference drug pethidine 100 mg.

Oxycodone 10 mg, pentazocine 20 mg, and a combination of morphine 10 mg with cyclizine 50 mg also showed strong efficacy, but no drug combinations outperformed the individual analgesics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Controlled comparison of the efficacy of fourteen preparations in the relief of postoperative pain. Morrison, JD., Loan, WB., Dundee, JW.[2019]

In a study of 303 patients undergoing ventral hernia repair, the addition of methocarbamol to pain management led to a significant reduction in the amount of opioids prescribed at discharge, decreasing from 75 MME to 60 MME.

Despite the lower opioid prescriptions, there was no increase in the need for opioid refills, suggesting that methocarbamol effectively manages pain without increasing reliance on opioids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of methocarbamol on opioid use after ventral incisional hernia repair. Desai, S., Carbonell, C., Hoffman, K., et al.[2023]

In a study of patients undergoing primary ventral and inguinal hernia repairs, the addition of methocarbamol significantly reduced opioid prescriptions and total morphine milligram equivalents (MME) without increasing the need for additional pain relief medications.

Patients receiving methocarbamol had a lower percentage of opioid prescriptions (55.8% for PVHR and 67.3% for IHR) and lower MME (20 for PVHR and 25 for IHR), indicating that methocarbamol can effectively manage pain while minimizing opioid use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of methocarbamol on opioid use after primary ventral and inguinal hernia repair. Crosier, C., Hammond, B., Carbonell, C., et al.[2023]

In the HOPE Hernia-1 study involving patients undergoing herniorrhaphy, the combination of HTX-011 (extended-release bupivacaine/low-dose meloxicam) with ibuprofen and acetaminophen resulted in 89.1% to 93.6% of patients not requiring opioid prescriptions post-surgery, indicating effective pain management without opioids.

The treatment regimen was well tolerated, with 95% of patients experiencing an opioid-free recovery and high satisfaction rates, suggesting that HTX-011 can significantly reduce opioid use while maintaining patient comfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Opioid-Free Recovery After Hernia Repair with HTX-011 as the Foundation of a Non-Opioid, Multimodal Analgesia Regimen in a Real-World Setting: A Randomized, Open-Label Study. Minkowitz, H., Soto, R., Fanikos, J., et al.[2023]

A multimodal approach to managing acute postoperative pain, which includes various medications like alpha 2 agonists, gabapentinoids, and dexamethasone, can enhance pain relief while potentially reducing opioid use and associated side effects.

Alpha 2 agonists can provide opioid-sparing effects but may cause hypotension and bradycardia, highlighting the need for careful monitoring, while dexamethasone has been shown to effectively reduce postoperative nausea and vomiting, making it a valuable adjunct in pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multimodal Analgesia, Current Concepts, and Acute Pain Considerations. Helander, EM., Menard, BL., Harmon, CM., et al.[2022]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Oliceridine: A Novel Drug for the Management of Moderate to Severe Acute Pain - A Review of Current Evidence. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Anticipating and treating opioid-associated adverse effects. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Acute pain management pharmacology for the patient with concurrent renal or hepatic disease. [2019]

4. Romania pubmed.ncbi.nlm.nih.gov

Safety issues of current analgesics: an update. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

Toxicities of opioid analgesics: respiratory depression, histamine release, hemodynamic changes, hypersensitivity, serotonin toxicity. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Controlled comparison of the efficacy of fourteen preparations in the relief of postoperative pain. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Impact of methocarbamol on opioid use after ventral incisional hernia repair. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Impact of methocarbamol on opioid use after primary ventral and inguinal hernia repair. [2023]

9. New Zealand pubmed.ncbi.nlm.nih.gov

Opioid-Free Recovery After Hernia Repair with HTX-011 as the Foundation of a Non-Opioid, Multimodal Analgesia Regimen in a Real-World Setting: A Randomized, Open-Label Study. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Multimodal Analgesia, Current Concepts, and Acute Pain Considerations. [2022]