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

Trial Summary

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 data supports the effectiveness of the nonopioid pain control treatment for broken bones?

Research shows that nonopioid pain treatments can be as effective as opioids for managing pain after surgeries like meniscus and thyroid surgeries. These treatments can help reduce the risks associated with opioid use, such as addiction, while still providing good pain relief. ^{1 2 3 4 5}

Is the nonopioid pain control regimen safe for humans?

Research suggests that nonopioid pain control regimens can be effective and are generally considered safe for managing pain after surgeries, like meniscus or hand surgeries, without the risks associated with opioids. ^{1 2 3 6 7}

How does the nonopioid pain control regimen for broken bones differ from other treatments?

The nonopioid pain control regimen is unique because it uses a combination of non-opioid medications, such as non-steroidal anti-inflammatory drugs (NSAIDs), gabapentinoids, and muscle relaxants, to manage pain without the risk of opioid dependence. This approach is designed to minimize opioid use and its associated risks, offering an alternative for effective pain management. ^{1 2 3 8 9}

What is the purpose of this trial?

An open reduction and internal fixation is a painful procedure requiring intensive postoperative pain management. Traditionally, opioid analgesia has been the gold standard for postoperative pain control. However, given the harmful side effect profile and opioid epidemic in the United States, it is advantageous to use alternate forms of analgesia. Multimodal pain control captures the effectiveness of different analgesic modalities and maximizes analgesia while minimizing side effects. The theory behind their use is that agents with different mechanisms of action work synergistically in preventing acute pain. Objective: To measure postoperative pain control in patients in two treatment arms of ORIF of the clavicle: a treatment group given a nonopioid pain control regimen, and a standard of care control group given standard opioid pain control regimen. Study Design: A randomized single blinded standard of care controlled clinical trial comparing pain management interventions. All adult patients scheduled for an ORIF following a traumatic fracture by fellowship trained Trauma surgeons will be eligible for inclusion. Patients will be excluded if their medical history presents known allergies or intolerance to Motrin, Lyrica, Tylenol, Zanaflex, substantial alcohol or drug abuse, and pregnancy, history of narcotics within 6 months of surgery, renal impairment, peptic ulcer disease, GI bleeding. On the day of surgery, patients will be randomized to receive a nonopioid pain control regimen or an opioid regimen using a computer-generated sequence. If pain is uncontrolled, patients will also be sent home with a prescription with 10 pills of 5 mg of Oxycodone for breakthrough pain. The amount of oxycodone taken will be recorded. Patients can call the resident on call, available 24-hours per day, if additional pain control is needed. Treatment: All patients will undergo previously scheduled ORIF of the clavicle in standard fashion and be randomized to the non-narcotic pain regimen vs the narcotic pain regimen.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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 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]

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]

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]

References

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

Multimodal Nonopioid Pain Protocol Provides Equivalent Pain Versus Opioid Control Following Meniscus Surgery: A Prospective Randomized Controlled Trial. [2021]

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

Nonopioid Adjuncts and Alternatives. [2021]

3. United States 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. [2022]

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

Pain management in trauma patients affected by the opioid epidemic: A narrative review. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Nonopioid Versus Opioid Analgesics After Thyroid and Parathyroid Surgery: A Systematic Review. [2023]

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

Comparative efficacy and safety of long-acting oral opioids for chronic non-cancer pain: a systematic review. [2022]

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

The Burden of Opioid-Related Adverse Drug Events on Hospitalized Previously Opioid-Free Surgical Patients. [2023]

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

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

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

Multi-modal Pain Control Protocol Decreases Narcotic Consumption in an Inpatient Trauma Population. [2022]