Clinical trial NCT05215236: Opiate Sparing Protocol Randomized Controlled Trial in Open Distal Radius Fracture Repair
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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Distal Radius Fracture
Lead sponsor: Campbell Clinic
Sponsor class: OTHER
First posted: 2022-01-31
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Oral Morphine Equivalent
timeFrame: postoperative day to two week visit
measure: Oral Morphine Equivalent
timeFrame: two week to six week visit
measure: Oral Morphine Equivalent
timeFrame: six week to twelve week visit
Secondary outcomes:
measure: Visual Analog Score
timeFrame: postoperative day to two week visit
measure: Visual Analog Score
timeFrame: six week visit
measure: Visual Analog Score
timeFrame: twelve week visit
Other outcomes:
measure: Incidence of treatment-emergent adverse event
timeFrame: postoperative day to two week visit
measure: Incidence of treatment-emergent adverse event
timeFrame: two week to six week visit
measure: Incidence of treatment-emergent adverse event
timeFrame: six week to twelve week visit
measure: Patient satisfaction Score
timeFrame: postoperative day to two week visit
measure: Patient satisfaction Score
timeFrame: two week to six week visit
measure: Patient satisfaction Score
timeFrame: six week to twelve week visit
Locations:
city: Germantown
country: United States
facility: Campbell Clinic
state: Tennessee
Study officials:
affiliation: Campbell Clinic
name: William J Weller, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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.
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.
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.
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.