Opioid-Free Approach for Postoperative Pain

Recruiting at 2 trial locations

Overseen By Alexander Dawes

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Emory University

Must not be taking: Opioids

Disqualifiers: Alcohol abuse, Advanced renal disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 6 weeks

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a pain management approach called Opioid-Free Orthopaedics can effectively control post-surgery pain without opioids. Participants will receive either traditional opioid medication or a placebo for comparison. The trial targets individuals with advanced arthritis undergoing joint replacement or certain orthopedic surgeries. Those who have tried non-surgical treatments like physical therapy for over three months may be suitable candidates. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to potentially groundbreaking pain management solutions.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those who have used opioids in the last 3 months. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that opioid-free treatments for managing post-surgical pain can be safe and manageable. Studies on combining different pain relief methods, known as multimodal pain management, indicate that this approach effectively controls pain with fewer side effects. Patients often report high satisfaction.

In past studies, individuals using opioid-free methods experienced fewer problems and side effects compared to those using opioids. This suggests that an opioid-free approach could be a safer option for post-surgical pain management.

Overall, these findings suggest that the opioid-free plan in this trial is likely to be well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about the opioid-free approach for postoperative pain because it offers a potential alternative to traditional opioid treatments like oxycodone. Unlike standard opioid medications, which carry risks of addiction and side effects, this method focuses on managing pain without these drugs. This approach can reduce the risk of opioid dependence and enhance recovery experiences for patients. By exploring non-opioid options, researchers hope to find effective ways to control pain while minimizing the negative impacts associated with opioid use.

What evidence suggests that this trial's treatments could be effective for postoperative pain?

Research has shown that managing pain after surgery without opioids can be effective. In this trial, participants in the Opioid Group will receive oxycodone, while those in the Placebo Group will receive a placebo. Studies have found that combining different pain relief methods can control pain as effectively as opioids. For instance, one study found this approach worked as well as traditional opioid treatments for pain control. Another study showed that patients required fewer opioids after surgery when using this method. This suggests that an opioid-free plan could effectively manage pain without the risks associated with opioids. ^{2 3 4 6 7}

Who Is on the Research Team?

Eric Wagner, MD, MS

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

This trial is for adults over 18 with advanced arthritis needing joint replacement or orthopaedic surgery on limbs, who have tried nonoperative treatments. Excluded are pregnant women, minors, those unwilling to consent, patients with recent opioid use, significant other injuries or conditions like uncontrolled diabetes or liver/renal disease.

Inclusion Criteria

I am having surgery on my finger, hand, wrist, forearm, or elbow.

I am having a joint replacement due to severe arthritis.

I've tried non-surgical treatments like rest, injections, and physical therapy for over 3 months.

Exclusion Criteria

Before joining the study, you will have blood tests to check how well your kidneys and liver are working.

I do not have major injuries, infections, substance abuse issues, recent opioid use, severe kidney or liver disease, issues with nerve blocks, uncontrolled diabetes (HbA1C >9.0), or conditions preventing the use of Aspirin.

Workman's compensation status, minors, vulnerable subjects, women who are pregnant, or those who are not willing to consent to participate in the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either encapsulated opioids or placebo as part of a multimodal pain control regimen after orthopedic surgery

6 weeks

Multiple visits for pain assessment and monitoring

Follow-up

Participants are monitored for safety, effectiveness, and complications after treatment

60 months

Follow-up visits at 6 weeks, 3 months, 6 months, 12 months, 24 months, and 60 months

What Are the Treatments Tested in This Trial?

Interventions

• Opioid-Free Orthopaedics

Trial Overview The study compares the effectiveness of a multimodal pain control regimen with and without opioids in managing post-surgery pain. Participants will receive either Oxycodone tablets or placebo pills after their orthopaedic procedures.

How Is the Trial Designed?

Group I: Placebo Group Experimental Treatment 1 Intervention

Participants will receive encapsulated placebo tablets x24, to take po q6 hours as need for pain after surgery "Safety" Prescription: Oxycodone5 mg po q6 hours as needed for pain

Group II: Opioid Group Active Control 1 Intervention

Participants will receive encapsulated Oxycodone 5 mg tablets x24, to take po q6 hours as needed after surgery Safety" Prescription: Oxycodone5 mg po q6 hours as needed for pain

Opioid-Free Orthopaedics is already approved in United States, European Union for the following indications:

Approved in United States as Multimodal Pain Management for:

• Postoperative pain management in orthopaedic surgery

Approved in European Union as Non-Opioid Orthopaedic Pain Management for:

• Postoperative pain management in orthopaedic procedures

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

Published Research Related to This Trial

The manuscript emphasizes the importance of alternative and non-opioid pain management strategies in perioperative care, highlighting that opioids are no longer considered the primary solution for pain relief.

It discusses various effective non-opioid options, including interventional pain techniques, physical therapy, exercise, and nutritional counseling, advocating for a personalized, multimodal approach to pain management as recommended by the CDC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-Opioid Perioperative Pain Strategies for the Clinician: A Narrative Review. Kaye, AD., Granier, AL., Garcia, AJ., et al.[2021]

A multimodal analgesic approach, which combines various pain relief methods, is effective in improving postoperative pain management and reducing the need for opioids, but its implementation is not consistent across all practices.

An optimal regimen should include acetaminophen, non-steroidal anti-inflammatory drugs, dexamethasone, and regional analgesic techniques, while also considering patient education and non-pharmacological interventions, especially for those at high risk for postoperative pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rational Multimodal Analgesia for Perioperative Pain Management. Joshi, GP.[2023]

A new opioid-free pain management pathway for shoulder arthroplasty significantly reduced pain levels compared to a traditional opioid-containing pathway, with lower median pain ratings at 12 hours, 24 hours, and 2 weeks post-surgery.

The opioid-free group required much less opioid medication overall (20 mg vs. 4936.25 mg in the opioid group) and reported no readmissions or significant side effects, indicating that this approach is both safe and effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Opioid-free shoulder arthroplasty is safe, effective, and predictable compared with a traditional perioperative opiate regimen: a randomized controlled trial of a new clinical care pathway. Jolissaint, JE., Scarola, GT., Odum, SM., et al.[2022]

A multimodal pain management strategy that combines nonopioid analgesics and techniques can enhance pain relief and decrease the need for opioids during upper extremity surgery.

The review highlights the importance of exploring various nonopioid options for pain management both during and after surgery, suggesting a shift towards more comprehensive pain management approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Opioid-Sparing Pain Management in Upper Extremity Surgery: Part 1: Role of the Surgeon and Anesthesiologist. Pulos, BP., Bowers, MR., Shin, AY., et al.[2020]

A multimodal pain management strategy effectively combines nonopioid medications and techniques to enhance pain relief and decrease the need for opioids, particularly in upper extremity surgery.

The review highlights various nonopioid analgesic options and anesthetic techniques that can be used post-surgery, suggesting a shift towards safer pain management practices that minimize opioid use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Opioid-Sparing Pain Management in Upper Extremity Surgery: Part 2: Surgeon as Prescriber. Bowers, MR., Pulos, N., Pulos, BP., et al.[2020]

Multimodal pain management, which combines various analgesic agents and techniques, is essential for effective pain control after major joint replacement surgeries, leading to quicker recovery and higher patient satisfaction.

Understanding the mechanisms of pain and how different medications work together allows healthcare providers to tailor pain management strategies, potentially reducing reliance on opioids and improving overall patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multimodal Pain Management for Major Joint Replacement Surgery. Goode, VM., Morgan, B., Muckler, VC., et al.[2020]

A nonopioid multimodal analgesia protocol can effectively reduce pain and the need for opioids after common sports medicine procedures, promoting safer pain management.

This approach minimizes side effects and maintains patient satisfaction, suggesting it is a viable alternative to traditional opioid prescriptions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Editorial Commentary: Opioids After Orthopaedic Surgery: Who Needs 'Em? Kluczynski, MA.[2020]

Citations

1. journals.sagepub.com journals.sagepub.com/doi/10.1177/19386400251333042

Comparison of an Opioid-Free Multimodal Pain Regimen ... Overall, these results suggest that an opioid-free postoperative treatment regimen has similar effectiveness in controlling a patient's pain ...

2. trialx.com trialx.com/clinical-trials/listings/242425/opioid-free-orthopaedics/?&geo_lat=33.9295&geo_lng=-84.1032&radius=10&place=Lawrenceville&user_country=United%20States

Opioid-Free Orthopaedics | Clinical Research Trial Listing ... The goal of this investigation is to compare effectiveness of this multimodal regimen at controlling postoperative pain with and without the use ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2773157X24001498

Opioid-free postoperative pain management in total knee ... The purpose of this scoping review was to explore the effectiveness of opioid-free postoperative pain management regimens for total joint arthroplasty (TJA).

4. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK572072/

Multimodal Postoperative Pain Control After Orthopaedic ... Multimodal pain control is an important modality to control pain in the postoperative period in all patients undergoing surgery or various other procedures.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11577478/

Postoperative Opioid Reduction Using a Multimodal Pain ... A division-level multimodal pain protocol applied to orthopaedic sports medicine procedures led to decreased opioid prescription postoperatively.

6. clinicaltrial.be clinicaltrial.be/en/details/174790?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Opioid-Free Orthopaedics The team will assess patient's pain levels, satisfaction, opioid usage, side effects, patient reported outcomes, and complications. This study ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9042766/

Postoperative Multimodal Pain Management and Opioid ... Many multimodal pain management protocols offer improved pain control and decreased opioid consumption after arthroscopic surgery.