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

Distal Radius Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05215236
• Other study ID #: 21-08332-FB
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: March 31, 2025

Study information

• Verified date: August 2023
• Source: Campbell Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 72
• Est. completion date: March 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Distal Radius Fracture
• Fractures, Bone
• Radius Fractures
• Wrist Fractures

Intervention

Other:
• Opiate Sparing
Subjects will receive non-opiate medications for pain control
• Opiate Based
Subjects will receive opiate based medications for pain control

Locations

Country	Name	City	State
United States	Campbell Clinic	Germantown	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Campbell Clinic

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of treatment-emergent adverse event	monitoring for safety events	postoperative day to two week visit
Other	Incidence of treatment-emergent adverse event	monitoring for safety events	two week to six week visit
Other	Incidence of treatment-emergent adverse event	monitoring for safety events	six week to twelve week visit
Other	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
Other	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
Other	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
Primary	Oral Morphine Equivalent	opiate pill count	postoperative day to two week visit
Primary	Oral Morphine Equivalent	opiate pill count	two week to six week visit
Primary	Oral Morphine Equivalent	opiate pill count	six week to twelve week visit
Secondary	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
Secondary	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
Secondary	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