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

72 Participants Needed

Trial Summary

What is the purpose of this trial?

A comparison of oral morphine equivalents between an opiate sparing cohort and an opiate based cohort following open reduction internal fixation of a distal radius fracture.

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.

What data supports the effectiveness of the Opiate Sparing treatment for wrist fractures?

Research shows that following specific opioid-prescribing guidelines for upper extremity surgeries, including wrist procedures, can effectively manage pain while minimizing opioid use. Patients reported high satisfaction with the pain relief provided, and the need for additional refills was low, indicating the effectiveness of these guidelines in reducing opioid consumption. ^{1 2 3 4 5}

Is the opiate sparing protocol for wrist fractures safe for humans?

The research suggests that using opioid-sparing strategies, like nerve blocks, can enhance recovery and reduce opioid use after hand surgeries, which may imply a safer approach by minimizing the risk of prolonged opioid use and its adverse effects. ^{1 4 5 6 7}

How does the opiate sparing treatment for wrist fractures differ from other treatments?

The opiate sparing treatment for wrist fractures is unique because it aims to reduce the use of opioids while still managing pain effectively, which is important given the opioid epidemic. This approach is similar to strategies used in other surgeries, like hip replacements, where reducing opioid use has been shown to maintain pain control and improve recovery. ^{4 5 8 9 10}

Research Team

William J Weller, MD

Principal Investigator

Campbell Clinic

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

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

Risk of Prolonged Opioid Use Among Opioid-Naïve Patients Following Common Hand Surgery Procedures. [2022]

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

Implementing Prescribing Guidelines for Upper Extremity Orthopedic Procedures: A Prospective Analysis of Postoperative Opioid Consumption and Satisfaction. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Decreasing Postoperative Opioid Prescriptions After Orthopedic Trauma Surgery: The "Lopioid" Protocol. [2022]

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

Evidenced-Based Opioid Prescribing Recommendations Following Hand and Upper-Extremity Surgery. [2022]

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

Perioperative Pain Control in Upper Extremity Surgery: Prescribing Patterns, Recent Developments, and Opioid-Sparing Treatment Strategies. [2023]

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

Prolonged opioid use after distal radius fracture. [2023]

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

An opioid-free anaesthetic using nerve blocks enhances rapid recovery after minor hand surgery in children. [2010]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Fracture location impacts opioid demand in upper extremity fracture surgery. [2021]

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

Upper-Extremity Nerve Decompression Under Local Anesthesia: A Systematic Review of Methods for Reduction of Postoperative Pain and Opioid Consumption. [2021]

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

Utilization of a Novel Opioid-Sparing Protocol in Primary Total Hip Arthroplasty Results in Reduced Opiate Consumption and Improved Functional Status. [2021]