Opioid-Free Pain Treatment for Broken Bones

Overseen By Dave Turkowitch, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Kansas Medical Center

Must not be taking: Chronic opioids

Disqualifiers: Head injury, CKD, Cirrhosis, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 6 months

250 Participants Needed

Trial Summary

What is the purpose of this trial?

Analgesic drug study that will compare pain outcomes of opioid analgesia and opioid-free analgesia in post-operative orthopedic patients.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are a chronic opioid user, you would not be eligible to participate.

What data supports the effectiveness of the Opioid-Free Pain Treatment for broken bones?

Research shows that opioid-free pain management can be effective and safe, as seen in a study where patients undergoing shoulder surgery had successful pain relief without opioids. This suggests that similar approaches might work for other conditions, like broken bones. ^{1 2 3 4 5}

Is opioid-free pain treatment generally safe for humans?

There is limited specific safety data on opioid-free pain treatments for broken bones, but non-opioid options have been recommended for their benefits in managing pain without the risks associated with opioids. These treatments are part of a broader approach to pain management that includes various therapies and are generally considered safe when tailored to individual needs. ^{6 7 8 9 10}

How is the Opioid-Free Pain Treatment for broken bones different from other treatments?

The Opioid-Free Pain Treatment is unique because it avoids the use of opioids, which can hinder bone healing and lead to addiction. Instead, it uses a combination of non-opioid medications and therapies, like acetaminophen, nonsteroidal anti-inflammatory drugs, and complementary therapies such as acupuncture, to manage pain effectively without the risks associated with opioids. ^{1 11 12 13 14}

Eligibility Criteria

Adults over 18 who need surgery for certain bone fractures and can consent to participate. Excluded are those with head injuries, on narcotics, pregnant/nursing, with chronic kidney disease or cirrhosis (for opioid-free group), chronic opioid users, or having revision surgery.

Exclusion Criteria

I have CKD or cirrhosis, so I qualify only for the standard opioid treatment.

You regularly take strong pain medications called opioids for a long time.

I have not had any of the fractures listed.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants receive either opioid or opioid-free analgesic protocol during the peri-operative period

6 months

Regular visits as per surgical follow-up schedule

Follow-up

Participants are monitored for postoperative complications and pain management effectiveness

6 months

Periodic visits (in-person and virtual)

Treatment Details

Interventions

• Opioid-Free Pain Treatment

Trial Overview The study is testing pain management in orthopedic patients after surgery without using opioids, comparing it to traditional pain treatment that includes opioids.

Participant Groups

Group I: Opioid-Free pain treatment (Block 2) Experimental Treatment 1 Intervention

Pain treatment regiment without the use of opioids. All other pain medication may be used under the discretion of the medical care team and surgeon.

Group II: Opioid pain treatment (Block 1) Active Control 1 Intervention

Standard of care pain treatment regimen that involves the use of opioids. Discretion of the medical care team and surgeon will be used for specific opioid pain treatment prescription (quantity, frequency) based on standard of care procedures. All forms of treatment are allowed for the standard of care group which may include but are not limited to blocks, opioids, patient-controlled analgesia, NSAIDs, acetaminophen, muscle relaxing agents, sedation medications, and neuropathic pain medications.

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials

527

Recruited

181,000+

Findings from Research

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]

In a study of 303 patients undergoing elective abdominal colorectal surgery, approximately 67.7% were able to avoid opioid use after leaving the postanesthesia care unit, demonstrating the feasibility of an opioid-free analgesia protocol.

Patients who successfully avoided opioids tended to be older, had fewer complications, and experienced shorter hospital stays, suggesting that certain demographic and clinical factors may contribute to the success of opioid-free surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Achieving Opioid-Free Major Colorectal Surgery: Is It Possible? Yap, R., Nassif, G., Hwang, G., et al.[2021]

In a study of 100 patients scheduled for orthopedic sports procedures, 42 preferred opioids for postoperative pain management, particularly those with a history of previous surgeries and higher preoperative pain scores.

Patients who preferred opioids were less concerned about addiction and side effects, indicating a need for better preoperative education on the risks of opioids and the benefits of nonopioid pain management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient factors influencing the choice of opioid versus non-opioid postoperative analgesia following common sports procedures: a prospective survey study. Castle, JP., Jildeh, TR., Abbas, MJ., et al.[2023]

A systematic review of 38 studies involving patients undergoing general anesthesia found no significant difference in acute pain scores or opioid consumption between opioid-free anesthesia (OFA) and opioid-based anesthesia (OBA).

Patients receiving opioid-free anesthesia reported better quality of recovery and experienced less postoperative nausea and vomiting, although they had a higher incidence of bradycardia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Opioid-free anesthesia: A systematic review and meta-analysis. Feenstra, ML., Jansen, S., Eshuis, WJ., et al.[2023]

Opioids remain the primary treatment for severe acute pain in hospitalized patients, despite the rising prevalence of opioid use and dependence in the U.S.

This review emphasizes the importance of an evidence-based approach to safely and effectively manage acute pain in opioid-dependent patients, highlighting the need for nonopioid medications and nondrug treatments as part of a comprehensive pain management strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute Pain Management in Hospitalized Adult Patients with Opioid Dependence: A Narrative Review and Guide for Clinicians. Raub, JN., Vettese, TE.[2018]

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]

Opioid medications, particularly those targeting the μ-opioid receptor (μOR), are the most effective for pain management but come with serious side effects like respiratory depression and dependence.

There is a critical need for the development of new μOR analgesics that maintain pain relief properties while minimizing or eliminating adverse effects, as highlighted by recent research advancements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Designing Safer Analgesics via μ-Opioid Receptor Pathways. Chan, HCS., McCarthy, D., Li, J., et al.[2018]

This study is testing an opioid-free perioperative analgesic pathway for patients undergoing common elective orthopedic surgeries, aiming to assess its effectiveness compared to traditional opioid-based pain management.

The primary outcome will measure pain scores 24 hours post-surgery, with additional assessments on side effects and patient satisfaction, contributing to efforts to address the opioid crisis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study protocol: randomized controlled trial of opioid-free vs. traditional perioperative analgesia in elective orthopedic surgery. Shing, EZ., Leas, D., Michalek, C., et al.[2021]

In a study of Medicare beneficiaries averaging 80 years old, opioids were found to have a significantly higher risk of cardiovascular events and all-cause mortality compared to nonselective NSAIDs (nsNSAIDs).

Coxibs showed a reduced risk of gastrointestinal bleeding compared to nsNSAIDs, but both coxibs and nsNSAIDs had similar fracture risks, while opioids were associated with a much higher fracture risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The comparative safety of analgesics in older adults with arthritis. Solomon, DH., Rassen, JA., Glynn, RJ., et al.[2022]

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]

In a study using a rat fracture model, morphine administration significantly reduced callus strength and delayed bone healing at 8 weeks post-surgery compared to control groups, indicating potential negative effects of opioids on bone healing.

The morphine-treated rats showed inhibited callus resorption and remodeling, suggesting that opioid use may impede the natural healing process of fractures, which could lead to a reevaluation of pain management strategies in orthopaedic care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative opioid administration inhibits bone healing in an animal model. Chrastil, J., Sampson, C., Jones, KB., et al.[2021]

The NO PAin Trial is a randomized controlled trial involving 200 patients undergoing outpatient knee and shoulder arthroscopy, aiming to compare a non-opioid analgesia approach to standard opioid prescriptions for postoperative pain management.

The primary goal is to determine if the non-opioid approach reduces the consumption of oral morphine equivalents (OME) at 6 weeks post-surgery, potentially addressing the opioid overprescribing issue in orthopaedics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol for a multicenter randomized controlled trial comparing a non-opioid prescription to the standard of care for pain control following arthroscopic knee and shoulder surgery. [2021]

The implementation of an opioid-free multimodal pain regimen in 313 patients undergoing minimally invasive lobectomy resulted in significantly lower postoperative opioid use, with 56% of patients requiring no oral opioids and 91% not using a patient-controlled analgesia pump.

Patients on the opioid-free protocol experienced lower average pain scores and a dramatic increase in the percentage of patients discharged without an opioid prescription (62% compared to 7% previously), which may help reduce the risk of opioid addiction in the community.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multimodal Pain Management Protocol to Decrease Opioid Use and to Improve Pain Control After Thoracic Surgery. Clark, IC., Allman, RD., Rogers, AL., et al.[2023]

The ongoing opioid crisis has led to a shift in pain management strategies for trauma patients, emphasizing the use of nonopioid analgesics and complementary therapies to reduce reliance on opioids.

A variety of nonopioid agents, such as acetaminophen, NSAIDs, and gabapentinoids, along with complementary therapies like acupuncture and virtual reality, have been identified as effective alternatives or adjuncts to opioids for managing pain in trauma patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing Pain Control and Minimizing Opioid Use in Trauma Patients. Fortune, S., Frawley, J.[2021]

References

1. United States 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. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Achieving Opioid-Free Major Colorectal Surgery: Is It Possible? [2021]

3. India pubmed.ncbi.nlm.nih.gov

Patient factors influencing the choice of opioid versus non-opioid postoperative analgesia following common sports procedures: a prospective survey study. [2023]

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

Opioid-free anesthesia: A systematic review and meta-analysis. [2023]

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

Acute Pain Management in Hospitalized Adult Patients with Opioid Dependence: A Narrative Review and Guide for Clinicians. [2018]

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

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

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

Designing Safer Analgesics via μ-Opioid Receptor Pathways. [2018]

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

Study protocol: randomized controlled trial of opioid-free vs. traditional perioperative analgesia in elective orthopedic surgery. [2021]

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

The comparative safety of analgesics in older adults with arthritis. [2022]

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

Non-Opioid Perioperative Pain Strategies for the Clinician: A Narrative Review. [2021]

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

Postoperative opioid administration inhibits bone healing in an animal model. [2021]

12. England pubmed.ncbi.nlm.nih.gov

Protocol for a multicenter randomized controlled trial comparing a non-opioid prescription to the standard of care for pain control following arthroscopic knee and shoulder surgery. [2021]

13. Netherlands pubmed.ncbi.nlm.nih.gov

Multimodal Pain Management Protocol to Decrease Opioid Use and to Improve Pain Control After Thoracic Surgery. [2023]

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

Optimizing Pain Control and Minimizing Opioid Use in Trauma Patients. [2021]