Pain Control Regimen for Broken Bones

Overseen By William Hakeos

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Henry Ford Health System

Must not be taking: Motrin, Lyrica, Tylenol, others

Disqualifiers: Substantial alcohol or drug abuse, pregnancy, renal impairment, others

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

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 6 weeks

75 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new methods to manage pain after surgery for a broken collarbone. It compares traditional opioid painkillers to a nonopioid regimen to determine if nonopioid treatments can effectively control pain without the risks associated with opioids. Individuals scheduled for collarbone surgery who haven't recently used narcotics may be suitable candidates. Participants will receive either the standard opioid treatment or the new nonopioid pain control regimen. The goal is to identify which method provides better pain relief with fewer side effects. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, aiming to understand its benefits for more patients.

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

The trial protocol does not specify if you need to stop your current medications. However, you cannot participate if you have used narcotics in the last 6 months or have certain medical conditions like renal impairment or peptic ulcer disease.

What is the safety track record for these treatments?

Research has shown that nonopioid medications for managing post-surgery pain are generally safe. These treatments are effective and manageable for most, particularly in surgeries like meniscus repair. They also have fewer serious side effects compared to opioids, which can cause addiction and other health issues.

While opioids have a long history of use and are well understood, they carry risks of addiction and other side effects. This has prompted researchers to explore nonopioid alternatives.

Overall, nonopioid treatments seem to be a safer choice for many, effectively controlling pain without the need for opioids. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the nonopioid pain control regimen for broken bones because it offers an alternative to traditional opioid treatments, like morphine and oxycodone, which can be addictive and have significant side effects. This new approach focuses on non-narcotic options, potentially reducing the risk of addiction and side effects associated with opioids. Additionally, by exploring nonopioid solutions, this regimen could lead to safer pain management strategies, providing effective relief without the downsides of narcotics.

What evidence suggests that this trial's treatments could be effective for pain control in broken bones?

Research has shown that nonopioid pain relief can be as effective as opioids for managing post-surgery pain. For instance, one study found that nonopioid medications did not result in worse pain control compared to opioids over a year. Another study demonstrated that nonopioid treatments are safe and effective for managing pain after surgeries like tonsil removal. Additionally, nonopioid options help reduce risks associated with opioid use, such as addiction and overdose. In this trial, participants will receive either a nonnarcotic or narcotic postoperative pain control regimen. This evidence supports the effectiveness of nonopioid pain relief for managing pain after surgeries like clavicle surgery. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

Adults over 18 needing surgery for a traumatic fracture at specified hospitals in Michigan can join. They must not have allergies to certain pain meds, recent narcotics use, alcohol or drug abuse issues, kidney problems, stomach ulcers, GI bleeding or be pregnant.

Inclusion Criteria

I am over 18 and scheduled for surgery after a fracture at Henry Ford Hospital or its West Bloomfield location.

Exclusion Criteria

I do not have kidney problems, stomach ulcers, or any bleeding in my stomach.

I am allergic to Motrin, Lyrica, Tylenol, tramadol, or Zanaflex.

Substantial alcohol or drug abuse

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo ORIF of the clavicle and are randomized to receive either a nonopioid or opioid pain control regimen

6 weeks

Daily monitoring for the first 2 weeks, weekly visits until 6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

46 weeks

Postoperative visits up to 1 year

What Are the Treatments Tested in This Trial?

Interventions

• Nonopioid Pain Control Regimen

Trial Overview The trial is testing nonopioid versus opioid pain control after clavicle surgery. It's a randomized study where patients are blindly assigned to either the non-narcotic or narcotic pain medication group post-surgery.

How Is the Trial Designed?

Group I: Nonnarcotic Postoperative Pain Control Experimental Treatment 1 Intervention

Experimental group given nonopioid pain control regimen.

Group II: Narcotic Postoperative Pain Control Active Control 1 Intervention

Standard of care control group given standard opioid pain control regimen.

Nonopioid Pain Control Regimen is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Nonopioid Pain Management for:

• Pain management after arthroscopic hip procedures
• Mild to moderate pain
• Chronic pain

Approved in European Union as Nonopioid Pain Management for:

• Pain management after surgical procedures
• Mild to moderate pain
• Chronic pain

Approved in Canada as Nonopioid Pain Management for:

• Pain management after surgical procedures
• Mild to moderate pain
• Chronic pain

Who Is Running the Clinical Trial?

Henry Ford Health System

Lead Sponsor

Trials

334

Recruited

2,197,000+

Published Research Related to This Trial

Multimodality nonopioid analgesia has been shown to be effective for managing pain, suggesting it can be a valuable alternative to opioids.

The decision to use opioids or nonopioids for pain control should be guided by a careful assessment of the risks and benefits associated with each treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nonopioid Adjuncts and Alternatives. Husain, Q., Banks, C., Gray, ST.[2021]

The implementation of a multi-modal pain control (MMPC) protocol significantly reduced daily opioid consumption in patients, with an average of 22.5 morphine milligram equivalents (MMEs) per day compared to 60 MMEs in the standard pain control (STP) group.

Despite the lower opioid use, pain control remained effective, as daily pain scores were similar between the MMPC and STP groups, indicating that the MMPC can safely minimize opioid use without compromising pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multi-modal Pain Control Protocol Decreases Narcotic Consumption in an Inpatient Trauma Population. Biester, JML., Mentzer, CJ., Caswell, SR., et al.[2022]

Patients with prior opioid use after hand and upper-extremity surgery required significantly more opioid pills (28.8 pills) compared to nonopioid users (14.5 pills) and were less satisfied with their pain control.

Switching to a different opioid reduced the number of pills used by prior opioid users (24.6 pills) compared to those who continued on the same opioid (37.9 pills), indicating that alternative prescribing strategies may help manage postoperative pain more effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative Pain Management of Non-"Opioid-Naive" Patients Undergoing Hand and Upper-Extremity Surgery. Wong, KA., Goyal, KS.[2021]

This systematic review analyzed 16 randomized trials and 8 observational studies involving 1427 and 1190 patients, respectively, to evaluate the efficacy and safety of long-acting opioids for chronic non-cancer pain.

The review found insufficient evidence to conclude that different long-acting opioids have distinct efficacy or safety profiles compared to each other or to short-acting opioids, although some evidence suggested that long-acting and short-acting oxycodone are equally effective for pain control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative efficacy and safety of long-acting oral opioids for chronic non-cancer pain: a systematic review. Chou, R., Clark, E., Helfand, M.[2022]

In a study of 244 patients undergoing hand and upper-extremity surgery, providing written prescriptions for nonopioids did not significantly impact postoperative pain control or the amount of medication consumed.

Patients who had soft tissue procedures tended to use more nonopioids than opioids after surgery, regardless of whether they received a written prescription, suggesting a preference for nonopioid pain management in this group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Written Prescription for Over-the-Counter Nonopioid Pain Medications Does Not Increase the Likelihood of Use after Ambulatory Hand and Upper Extremity Surgery. Lynch, DJ., Lin, JS., Goyal, KS.[2022]

A study involving 61 patients who underwent meniscectomy or meniscal repair found that a multimodal nonopioid pain regimen provided equivalent pain control compared to a traditional opioid regimen, with no significant differences in pain levels during the first 10 days post-surgery.

Both pain management strategies resulted in similar patient-reported outcomes and side effects, indicating that nonopioid protocols can be a safe and effective alternative to opioids for postoperative pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multimodal Nonopioid Pain Protocol Provides Equivalent Pain Versus Opioid Control Following Meniscus Surgery: A Prospective Randomized Controlled Trial. Jildeh, TR., Okoroha, KR., Kuhlmann, N., et al.[2021]

In a study of 13,389 opioid-free patients who underwent surgery, 9.1% experienced opioid-related adverse drug events (ORADEs) after receiving postoperative opioids, highlighting a significant risk in this population.

Patients with ORADEs faced severe consequences, including 32% higher hospitalization costs, 45% longer hospital stays, and 2.2 times the odds of mortality, emphasizing the need for careful management of opioid use post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Burden of Opioid-Related Adverse Drug Events on Hospitalized Previously Opioid-Free Surgical Patients. Urman, RD., Seger, DL., Fiskio, JM., et al.[2023]

Nonopioid analgesic regimens are as effective as opioid analgesic regimens for managing postoperative pain after thyroid and parathyroid surgery, based on a systematic review of 2 randomized controlled trials.

Using nonopioid pain management may reduce the risk of opioid dependence, although one study noted a higher rate of postoperative pain-related calls in the nonopioid group, suggesting that while effective, nonopioid regimens may require closer monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nonopioid Versus Opioid Analgesics After Thyroid and Parathyroid Surgery: A Systematic Review. Moon, PK., Wei, EX., Hamid, MS., et al.[2023]

Chronic opioid use in trauma patients increases the risk of hospital admissions and the likelihood of developing opioid use disorder after discharge, highlighting the need for careful pain management strategies.

The review emphasizes the importance of multimodal pain management approaches that utilize nonopioid strategies to effectively manage acute pain while minimizing the risks of long-term opioid dependence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain management in trauma patients affected by the opioid epidemic: A narrative review. Karamchandani, K., Klick, JC., Linskey Dougherty, M., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11253739/

Opioid and non-opioid analgesic regimens after fracture and ... Filling a non-opioid analgesic in combination with an opioid was associated with an increased risk of SOREs after long bone fracture.

2. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06187584

NCT06187584 | SCHF Post-Op Study Between Opioid and ... This purpose of this study is to determine the efficacy of nonopioid versus opioid analgesic regimens following surgical fixation of Gartland Type III ...

3. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2673971

Effect of Opioid vs Nonopioid Medications on Pain-Related ... Treatment with opioids was not superior to treatment with nonopioid medications for improving pain-related function over 12 months.

4. fda.gov fda.gov/media/188612/download

Development of Non-Opioid Analgesics for Chronic Pain osteoarthritis, low back pain, bone fracture, bone metastases, burns). ... issues with this design and the extent of efficacy and safety data from ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S016558762500148X

Randomized clinical trial of non-opioid pain medications ... Our purpose was to determine if non-opioid pain control is safe and effective in the treatment of pain following intracapsular adenotonsillectomy (T&A).

6. sciencedirect.com sciencedirect.com/science/article/pii/S0883540325002414

Non-Opioid Analgesics for Postoperative Pain ... This review found that postoperative administration of nonopioid coanalgesia may alleviate the need for opioids and have modest protective effects on ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5626380/

Poorly controlled postoperative pain - PubMed Central - NIH Poorly controlled acute postoperative pain is associated with increased morbidity, functional and quality-of-life impairment, delayed recovery time, prolonged ...

8. withpower.com withpower.com/trial/phase-4-opioids-use-11-2023-b7bf2

Pain Control Regimen for Broken Bones Research suggests that nonopioid pain control regimens can be effective and are generally considered safe for managing pain after surgeries, like meniscus or ...