No vs. Minimal Opioids After Inguinal Hernia Repair

Recruiting in Palo Alto (17 mi)

+4 other locations

Overseen by Clayton C Petro, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: Clayton Petro

Must not be taking: Opioids, NSAIDs

Disqualifiers: Chronic pain, Extensive surgery, others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The investigators hypothesize that not prescribing opioids after uncomplicated, outpatient IHR will be non-inferior to prescribing opioids (5 tablets of Oxycodone, 5mg; or surgeon preference for intolerance) with respect to requests for opioid refills. Additionally, the investigators believe there will be no significant difference in postoperative readmission for pain quality of life at 30 days in either group.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are on opioids for chronic pain management, you cannot participate.

What data supports the effectiveness of using minimal opioids after inguinal hernia repair?

Research shows that using a combination of oxycodone and acetaminophen can effectively manage postoperative pain with fewer side effects compared to higher doses of opioids alone. This suggests that minimal opioid use, combined with other pain relief methods, could be effective for managing pain after inguinal hernia repair. ^{1 2 3 4 5}

Is it safe to use minimal or no opioids after inguinal hernia repair?

Research shows that using a combination of oxycodone with other medications like acetaminophen and ketorolac can effectively manage pain with fewer complications compared to using oxycodone alone. Additionally, combining oxycodone with acetaminophen can reduce side effects and improve safety compared to higher doses of oxycodone alone. ^{1 4 6 7 8}

How does the drug used in the trial differ from other treatments for inguinal hernia repair?

The trial explores using minimal or no opioids, like oxycodone, after inguinal hernia repair, which is unique because it aims to reduce or eliminate the use of opioids that are commonly prescribed for pain management, potentially minimizing the risk of addiction and side effects associated with these drugs. ^{9 10 11 12 13}

Research Team

Clayton C Petro, MD

Principal Investigator

The Cleveland Clinic

Eligibility Criteria

This trial is for adults over 18 who are having elective inguinal hernia repairs and can handle general anesthesia. It's not suitable for those with conditions that might complicate surgery or recovery.

Inclusion Criteria

I am 18 years old or older.

I can safely undergo general anesthesia.

I am scheduled for surgery to repair one or both sides of my groin hernia.

Exclusion Criteria

Patients who are not able to understand and sign a written consent form

I cannot undergo surgery with general anesthesia.

I cannot tolerate opioids or NSAIDs.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo inguinal hernia repair and are randomized to receive either minimal opioids or no opioids post-operatively

Immediate post-operative period

Follow-up

Participants are monitored for safety, opioid refill requests, and quality of life at 30 days post-operatively

4 weeks

1 visit (in-person) at one month

Treatment Details

Interventions

• Minimal opioids (Other)
• No opioids (Other)

Trial Overview The study is testing if avoiding opioids after hernia surgery is just as good as giving a small amount (5 tablets of Oxycodone, or another drug if there's an intolerance). They're looking at the need for more pain meds and quality of life after a month.

Participant Groups

Group I: No opioids Experimental Treatment 1 Intervention

Standard of care

Group II: Minimal Opioids Experimental Treatment 1 Intervention

Standard of care 5 tablets of Oxycodone (5mg) every 6 hours as needed for pain

Minimal opioids is already approved in Canada for the following indications:

Approved in Canada as Oxycodone for:

• Severe pain requiring opioid treatment
• Acute postoperative pain

Who Is Running the Clinical Trial?

Clayton Petro

Lead Sponsor

Trials

5

Recruited

1,600+

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+

David Peter

The Cleveland Clinic

Chief Medical Officer

MD, board-certified in Hospice and Palliative Medicine

Tomislav Mihaljevic

The Cleveland Clinic

Chief Executive Officer since 2018

MD from University of Zagreb School of Medicine

Findings from Research

In a study of 522 patients recovering from bunionectomy surgery, the dual-opioid Q8003 (morphine/oxycodone combination) showed significantly greater pain relief compared to either morphine or oxycodone alone, with higher pain intensity difference scores over 24 and 48 hours.

While Q8003 had a higher total morphine equivalent dose, it resulted in fewer patients needing additional ibuprofen for pain relief and only a modest increase in adverse events, indicating it is an effective option for managing postoperative pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase 3, randomized, double-blind comparison of analgesic efficacy and tolerability of Q8003 vs oxycodone or morphine for moderate-to-severe postoperative pain following bunionectomy surgery. Richards, P., Riff, D., Kelen, R., et al.[2022]

Opioid receptors, including mu (MOR), delta (DOR), and kappa (KOR), are crucial for mediating pain relief (analgesia) in animal models, while the role of the nociceptin receptor (ORL) remains unclear with mixed effects on pain.

A comparative analysis of opioid receptors across six vertebrate species suggests that these receptors evolved through gene duplication, with the MOR showing signs of rapid evolution, indicating potential differences in pain management across species.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The evolution of vertebrate opioid receptors. Stevens, CW.[2023]

References

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

Multi-Modal Pain Control in Ambulatory Hand Surgery. [2018]

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

Sage wisdom or anecdotal dictum? Equivalent opioid use after open, laparoscopic, and robotic inguinal hernia repair. [2019]

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

Analgesic and adverse effects of a fixed-ratio morphine-oxycodone combination (MoxDuo) in the treatment of postoperative pain. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Randomized, double-blind, placebo-controlled comparison of the analgesic efficacy of oxycodone 10 mg/acetaminophen 325 mg versus controlled-release oxycodone 20 mg in postsurgical pain. [2019]

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

Opioid utilization in minimally invasive versus open inguinal hernia repair. [2020]

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

A phase 3, randomized, double-blind comparison of analgesic efficacy and tolerability of Q8003 vs oxycodone or morphine for moderate-to-severe postoperative pain following bunionectomy surgery. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Oxycodone Extended-Release Capsule Utilization for Pain Management in a Cancer Palliative Care Clinic: A Retrospective Review. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of oxycodone HCl/niacin tablets for the treatment of moderate-to-severe postoperative pain following bunionectomy surgery. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Opioid activity profiles indicate similarities between the nociceptin/orphanin FQ and opioid receptors. [2023]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Binding and GTPgammaS autoradiographic analysis of preproorphanin precursor peptide products at the ORL1 and opioid receptors. [2023]

11. France pubmed.ncbi.nlm.nih.gov

[Cloning of prepronociceptin has led to the discovery of other biologically active peptides]. [2023]

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

The nociceptin receptor as a potential target in drug design. [2003]

13. Singapore pubmed.ncbi.nlm.nih.gov

The evolution of vertebrate opioid receptors. [2023]