Opiate Sparing Protocol for Wrist Fractures

Overseen By Margaret Knack, BSN, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Campbell Clinic

Must not be taking: Opioids, Ace inhibitors

Disqualifiers: Renal disease, Chronic pain, others

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

Compensation: Varies

Number of Visits: 2

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores different ways to manage pain after wrist surgery. One group will use fewer opiates and try other pain relievers like acetaminophen and gabapentin, while the other group will follow a more traditional opiate-based plan. The researchers aim to determine if using fewer opiates can still effectively control post-surgery pain. This trial may suit individuals who have had wrist surgery at Campbell Clinic and have not used opioids heavily in the last 90 days. As an unphased trial, it offers a unique opportunity to contribute to innovative pain management strategies.

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 taking angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers for high blood pressure, you cannot participate.

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

Research has shown that using fewer opioids and more non-opioid medications can safely and effectively manage pain after surgery. One study found that non-opioid treatments reduced the need for opioids, like oxycodone, after hand surgeries. This approach may lead to fewer side effects and quicker recovery.

In contrast, using more opioids for pain relief can be effective but often carries risks like nausea, dizziness, or dependence with long-term use. The opioid-based method is well-known and has been used for many years, but it requires careful monitoring to avoid these side effects.

Both treatment options have pros and cons, but the method using fewer opioids might offer a safer choice with fewer risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it's exploring how to manage wrist fracture pain while potentially reducing reliance on opiates. The opiate-sparing protocol combines non-opioid medications like acetaminophen, gabapentin, and celecoxib with standard pain management techniques, aiming to minimize the need for oxycodone. This approach could offer effective pain relief with fewer opiate-related side effects, such as addiction risks and severe nausea. The study's findings could pave the way for safer pain management options in fracture care.

What evidence suggests that this trial's treatments could be effective for wrist fractures?

Research has shown that using fewer opioids can effectively manage pain after surgeries like wrist fracture repairs. In this trial, participants in the Opiate Sparing arm will receive a combination of medications such as acetaminophen and gabapentin, along with non-drug methods like icing, to reduce the need for opioids. This approach not only helps control pain but also lowers the risk of opioid dependence. In contrast, participants in the Opiate Based arm will receive traditional methods that often rely on drugs like oxycodone for pain relief. While these drugs effectively relieve pain, they carry a higher risk of side effects and addiction. Therefore, using fewer opioids could offer a safer way to manage pain after wrist surgeries. ^{1 3 4 6 7}

Who Is on the Research Team?

William J Weller, MD

Principal Investigator

Campbell Clinic

Are You a Good Fit for This Trial?

This trial is for individuals needing surgery for a broken wrist, specifically an open distal radius fracture. Participants must speak and read English well and have a BMI of 45 or less. It's not for those on certain blood pressure meds, with kidney disease, under worker's comp, pregnant/breastfeeding women, recent opioid users, known drug sensitivities, or with other upper limb issues.

Inclusion Criteria

Fluent in verbal and written English

I had surgery to fix broken bones at Campbell Clinic.

Body Mass Index less than or equal to 45

Exclusion Criteria

I have chronic pain that lasts a long time.

I have an injury or condition in the same arm, but not including the wrist.

I have a history of kidney disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either an opiate sparing or opiate based protocol following open reduction internal fixation of distal radius fractures

12 weeks

Regular visits at 2, 6, and 12 weeks

Follow-up

Participants are monitored for safety, effectiveness, and patient satisfaction after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Opiate Based
• Opiate Sparing

Trial Overview The study compares two pain management strategies after wrist fracture surgery: one that tries to minimize the use of opiates (like morphine) and another that uses standard opiate-based treatment. The goal is to see which group needs fewer oral morphine equivalents post-surgery.

How Is the Trial Designed?

Group I: Opiate Sparing Experimental Treatment 1 Intervention

Standard icing and elevation therapy Acetaminophen 1000 milligrams by mouth every 8 hours for five days then as needed every 8 hours for pain control Gabapentin 100 milligrams by mouth three times per day for 14 days Celecoxib 100 milligrams by mouth two times per day for 5 days Esomeprazole 20 milligrams by mouth once per day for 14 days Promethazine 12.5 milligrams by mouth every 8 hours as needed for nausea or vomiting Docusate 100 milligrams by mouth two times per day while taking oxycodone Oxycodone 5 milligrams by mouth every 6 hours as needed for pain control unresponsive to other medications

Group II: Opiate Based Active Control 1 Intervention

Standard icing and elevation therapy Oxycodone 5-10 milligrams by mouth every 4 to 6 hours as needed for pain control Acetaminophen 1000 milligrams by mouth every 8 hours as needed for pain control Promethazine 12.5 milligrams by mouth every 8 hours as needed for nausea or vomiting Docusate 100 milligrams by mouth two times per day while taking oxycodone

Who Is Running the Clinical Trial?

Campbell Clinic

Lead Sponsor

Trials

15

Recruited

2,100+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05215236

Opiate Sparing Protocol Randomized Controlled Trial in ... This study will investigate the effectiveness of an opiate sparing protocol following open reduction and internal fixation (ORIF) of distal radius fractures on ...

2. withpower.com withpower.com/trial/phase-radius-fracture-distal-2-2022-29c4f

Opiate Sparing Protocol for Wrist Fractures The research suggests that using opioid-sparing strategies, like nerve blocks, can enhance recovery and reduce opioid use after hand surgeries, which may imply ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38490894/

Opioid Prescribing Rate for Nonoperative Distal Radius ... Conclusion: Over 90% of patients (106/118) continued to receive an opioid medication despite having a known risk factor for abuse. Additionally, we found older ...

4. ctv.veeva.com ctv.veeva.com/study/opiate-sparing-protocol-randomized-controlled-trial-in-open-distal-radius-fracture-repair

Opiate Sparing Protocol Randomized Controlled Trial in Open ... This study will document the safety and effectiveness of an opiate sparing, multimodal pain management protocol in properly selected patients ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0363502321004421

Distal Radius Fracture Clinical Practice Guidelines ... A novel opioid-sparing pain management protocol following total hip arthroplasty: effects on opioid consumption, pain severity, and patient-reported outcomes ...

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

Opioid and non-opioid analgesic regimens after fracture and ... Patients hospitalized for long bone fracture often require opioid use for appropriate pain management, which could potentially lead to a higher ...

7. jccpractice.com jccpractice.com/article/efficacy-and-safety-of-opioid-versus-non-opioid-multimodal-analgesia-in-orthopaedic-pain-management-a-prospective-observational-study-681/

Efficacy and Safety of Opioid Versus Non-Opioid Multimodal ... Non-opioid multimodal analgesia is an effective and safer alternative to opioid-based regimens for postoperative pain management in orthopaedic patients.