904 Participants Needed

No vs. Minimal Opioids After Inguinal Hernia Repair

Recruiting at 5 trial locations
KW
CC
RC
Overseen ByRyan C Ellis, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

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.12345

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.14678

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.910111213

Research Team

CC

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.
See 3 more

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
  • No opioids
Trial OverviewThe 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
2Treatment groups
Experimental Treatment
Group I: No opioidsExperimental Treatment1 Intervention
Standard of care
Group II: Minimal OpioidsExperimental Treatment1 Intervention
Standard of care 5 tablets of Oxycodone (5mg) every 6 hours as needed for pain

Minimal opioids is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Oxycodone for:
  • Severe pain requiring opioid treatment
  • Acute postoperative pain
🇪🇺
Approved in European Union as Oxycodone for:
  • Severe pain requiring opioid treatment
  • Acute postoperative pain
🇨🇦
Approved in Canada as Oxycodone for:
  • Severe pain requiring opioid treatment
  • Acute postoperative pain

Find a Clinic Near You

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+

Findings from Research

In a study of 79 patients undergoing thumb carpometacarpal arthroplasty or distal radius ORIF, the combination of oxycodone, acetaminophen, and ketorolac showed a trend towards better postoperative pain control and reduced opioid usage compared to other regimens.
Although not statistically significant, the group receiving oxycodone, acetaminophen, and ketorolac experienced fewer complications, suggesting that this combination may enhance safety and efficacy in managing postoperative pain.
Multi-Modal Pain Control in Ambulatory Hand Surgery.Harrison, RK., DiMeo, T., Klinefelter, RD., et al.[2018]
A study of 173 patients undergoing different types of inguinal hernia repairs (open, laparoscopic, and robotic) found no significant differences in opiate prescription amounts or pain management needs post-surgery.
The results suggest that the assumption that minimally-invasive hernia repair techniques lead to less postoperative pain may not be accurate, as all techniques required similar levels of pain medication.
Sage wisdom or anecdotal dictum? Equivalent opioid use after open, laparoscopic, and robotic inguinal hernia repair.Sheldon, RR., Do, WS., Weiss, JB., et al.[2019]
MoxDuo, a combination of immediate-release morphine and oxycodone, showed significantly better pain relief compared to its individual components in patients with moderate to severe postoperative pain, particularly in the 12 mg/8 mg dosage group.
The MoxDuo 6 mg/4 mg dosage resulted in a 50-75% reduction in common opioid-related side effects like nausea and dizziness compared to equivalent doses of morphine and oxycodone, suggesting it may be a safer option for pain management.
Analgesic and adverse effects of a fixed-ratio morphine-oxycodone combination (MoxDuo) in the treatment of postoperative pain.Richards, P., Riff, D., Kelen, R., et al.[2019]

References

Multi-Modal Pain Control in Ambulatory Hand Surgery. [2018]
Sage wisdom or anecdotal dictum? Equivalent opioid use after open, laparoscopic, and robotic inguinal hernia repair. [2019]
Analgesic and adverse effects of a fixed-ratio morphine-oxycodone combination (MoxDuo) in the treatment of postoperative pain. [2019]
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]
Opioid utilization in minimally invasive versus open inguinal hernia repair. [2020]
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]
Oxycodone Extended-Release Capsule Utilization for Pain Management in a Cancer Palliative Care Clinic: A Retrospective Review. [2023]
Efficacy and safety of oxycodone HCl/niacin tablets for the treatment of moderate-to-severe postoperative pain following bunionectomy surgery. [2022]
Opioid activity profiles indicate similarities between the nociceptin/orphanin FQ and opioid receptors. [2023]
Binding and GTPgammaS autoradiographic analysis of preproorphanin precursor peptide products at the ORL1 and opioid receptors. [2023]
[Cloning of prepronociceptin has led to the discovery of other biologically active peptides]. [2023]
12.United Statespubmed.ncbi.nlm.nih.gov
The nociceptin receptor as a potential target in drug design. [2003]
The evolution of vertebrate opioid receptors. [2023]