Prospective, Randomized, Controlled Trial of an Opiate Sparing Protocol Versus Standard Opiate Based Protocol Following Open Reduction Internal Fixation of Distal Radius Fractures
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Distal Radius Fracture
- Sponsor
- Campbell Clinic
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Oral Morphine Equivalent
- Status
- Completed
- Last Updated
- 6 months ago
Overview
Brief 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.
Detailed 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.
Investigators
William Jacob Weller
Principal Investigator
Campbell Clinic
Eligibility Criteria
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 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 receptor blockers for hypertension
Outcomes
Primary Outcomes
Oral Morphine Equivalent
Time Frame: six week to twelve week visit
opiate pill count
Secondary Outcomes
- Visual Analog Score(twelve week visit)