Opiate Sparing Protocol Randomized Controlled Trial in Open Distal Radius Fracture Repair

Last updated: August 23, 2024
Sponsor: Campbell Clinic
Overall Status: Active - Enrolling

Phase

N/A

Condition

N/A

Treatment

Opiate Sparing

Opiate Based

Clinical Study ID

NCT05215236
21-08332-FB
  • Ages 18-85
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Open reduction internal fixation surgery at Campbell Clinic Surgery Center

  • Body Mass Index less than or equal to 45

  • Fluent in verbal and written English

Exclusion

Exclusion Criteria:

  • Known sensitivity to medications in either protocol

  • Renal disease by medical history

  • Concomitant ipsilateral upper extremity injury or condition other than wrist

  • Chronic pain syndrome

  • Consumption of ten consecutive day so opioid use in the previous 90 days

  • Worker's compensation

  • Women who are pregnant, planning to become pregnant, or are breastfeeding

  • Takes either angiotensin-converting enzyme inhibitor or angiotensin II receptorblockers for hypertension

Study Design

Total Participants: 72
Treatment Group(s): 2
Primary Treatment: Opiate Sparing
Phase:
Study Start date:
March 01, 2022
Estimated Completion Date:
September 30, 2025

Study Description

Recently, the opioid epidemic has been the center of focus for healthcare providers and governmental agencies due to rising rates of opioid abuse, opioid-related fatalities, and overall economic burden of treating the opioid epidemic. The prescribing patterns of opioid pain medications have fallen under scrutiny and healthcare providers have sought alternative pain management strategies that have limited opioid pain medication use. As orthopaedic surgeons account for 7.7% of all dispensed opioid prescriptions within the United States, surgeons have investigated multimodal pain management strategies to assess effectiveness in controlling postoperative pain as well as limiting opioid use and opioid related complications. The literature documents the safety and effectiveness of non-steroid anti-inflammatory drugs (NSAID) and acetaminophen in soft tissue hand procedures and distal radius fracture plating. Currently, there remains no clear consensus on the ideal pain management strategy following open reduction internal fixation (ORIF) of distal radius fractures and the vast majority of strategies are based on opiate-driven protocols. This study will investigate the effectiveness of an opiate sparing protocol following open reduction and internal fixation (ORIF) of distal radius fractures on opiate consumption as measured by oral morphine equivalents at the 2, 6 and 12 week postoperative time point through collection of pill counts. Secondary outcomes are pain scores, patient satisfaction, and safety reporting (complications, reoperations, and readmissions) during the 12-week episode-of-care. This study will document the safety and effectiveness of an opiate sparing, multimodal pain management protocol in properly selected patients undergoing ORIF of distal radius fractures.

Following written consent documentation, Subjects will be randomized to either the opiate sparing cohort or the opiate based cohort at a 1:1 randomization. No blinding will occur as part of the study.

Connect with a study center

  • Campbell Clinic

    Germantown, Tennessee 38138
    United States

    Site Not Available

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