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

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Distal Radius Fracture
• Intervention / Treatment: Other: Opiate Sparing; Other: Opiate Based

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.

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • Campbell Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Opiate Sparing; 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; Subjects will receive non-opiate medications for pain control
Active Comparator: Opiate Based; 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; Subjects will receive opiate based medications for pain control

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of treatment-emergent adverse event	monitoring for safety events	postoperative day to two week visit
Incidence of treatment-emergent adverse event	monitoring for safety events	two week to six week visit
Incidence of treatment-emergent adverse event	monitoring for safety events	six week to twelve week visit
Patient satisfaction Score	patient reported satisfaction with pain management from 0 to 10 where 0 is very unsatisfied and 10 is very satisfied	postoperative day to two week visit
Patient satisfaction Score	patient reported satisfaction with pain management from 0 to 10 where 0 is very unsatisfied and 10 is very satisfied	two week to six week visit
Patient satisfaction Score	patient reported satisfaction with pain management from 0 to 10 where 0 is very unsatisfied and 10 is very satisfied	six week to twelve week visit

Collaborators and Investigators

• Sponsor: Campbell Clinic
• Investigators: Principal Investigator: William J Weller, MD, Campbell Clinic

Publications and helpful links

General Publications

• Thybo KH, Hagi-Pedersen D, Dahl JB, Wetterslev J, Nersesjan M, Jakobsen JC, Pedersen NA, Overgaard S, Schroder HM, Schmidt H, Bjorck JG, Skovmand K, Frederiksen R, Buus-Nielsen M, Sorensen CV, Kruuse LS, Lindholm P, Mathiesen O. Effect of Combination of Paracetamol (Acetaminophen) and Ibuprofen vs Either Alone on Patient-Controlled Morphine Consumption in the First 24 Hours After Total Hip Arthroplasty: The PANSAID Randomized Clinical Trial. JAMA. 2019 Feb 12;321(6):562-571. doi: 10.1001/jama.2018.22039.
• Sabatino MJ, Kunkel ST, Ramkumar DB, Keeney BJ, Jevsevar DS. Excess Opioid Medication and Variation in Prescribing Patterns Following Common Orthopaedic Procedures. J Bone Joint Surg Am. 2018 Feb 7;100(3):180-188. doi: 10.2106/JBJS.17.00672.
• Galos DK, Taormina DP, Crespo A, Ding DY, Sapienza A, Jain S, Tejwani NC. Does Brachial Plexus Blockade Result in Improved Pain Scores After Distal Radius Fracture Fixation? A Randomized Trial. Clin Orthop Relat Res. 2016 May;474(5):1247-54. doi: 10.1007/s11999-016-4735-1. Epub 2016 Feb 11.
• Martinez L, Ekman E, Nakhla N. Perioperative Opioid-sparing Strategies: Utility of Conventional NSAIDs in Adults. Clin Ther. 2019 Dec;41(12):2612-2628. doi: 10.1016/j.clinthera.2019.10.002. Epub 2019 Nov 14.
• Niedermeier SR, Crouser N, Hidden K, Jain SA. Pain Management following Open Reduction and Internal Fixation of Distal Radius Fractures. J Wrist Surg. 2021 Feb;10(1):27-30. doi: 10.1055/s-0040-1716508. Epub 2020 Oct 14.
• O'Neil JT, Wang ML, Kim N, Maltenfort M, Ilyas AM. Prospective Evaluation of Opioid Consumption After Distal Radius Fracture Repair Surgery. Am J Orthop (Belle Mead NJ). 2017 Jan/Feb;46(1):E35-E40.
• Padilla JA, Gabor JA, Schwarzkopf R, Davidovitch RI. A Novel Opioid-Sparing Pain Management Protocol Following Total Hip Arthroplasty: Effects on Opioid Consumption, Pain Severity, and Patient-Reported Outcomes. J Arthroplasty. 2019 Nov;34(11):2669-2675. doi: 10.1016/j.arth.2019.06.038. Epub 2019 Jun 26.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): March 31, 2025

Study Registration Dates

• First Submitted: January 18, 2022
• First Submitted That Met QC Criteria: January 18, 2022
• First Posted (Actual): January 31, 2022

Study Record Updates

• Last Update Posted (Actual): August 4, 2023
• Last Update Submitted That Met QC Criteria: August 3, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Forearm Injuries; Wrist Injuries; Fractures, Bone; Radius Fractures; Wrist Fractures; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Opiate Alkaloids
• Other Study ID Numbers: 21-08332-FB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No