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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prospective, Randomized, Controlled Trial of an Opiate Sparing Protocol Versus Standard Opiate Based Protocol Following Open Reduction Internal Fixation of Distal Radius Fractures

Conditions
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Distal Radius Fracture

Intervention / Treatment
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* Other: Opiate Sparing
* Other: Opiate Based


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Opiate Sparing<br>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 | Other: Opiate Sparing<br>* Subjects will receive non-opiate medications for pain control<br>|
| Active Comparator: Opiate Based<br>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 | Other: Opiate Based<br>* Subjects will receive opiate based medications for pain control<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oral Morphine Equivalent | opiate pill count | postoperative day to two week visit | 
| Oral Morphine Equivalent | opiate pill count | two week to six week visit | 
| Oral Morphine Equivalent | opiate pill count | six week to twelve week visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Score | Patient reported pain score from 0 to 10 where 0 is no pain and 10 is the most pain | postoperative day to two week visit | 
| Visual Analog Score | Patient reported pain score from 0 to 10 where 0 is no pain and 10 is the most pain | six week visit | 
| Visual Analog Score | Patient reported pain score from 0 to 10 where 0 is no pain and 10 is the most pain | twelve week visit |