Campbell Clinic
Germantown, Tennessee, 38138, United States
NCT Number: NCT05215236
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.
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Notify Me18 year–85 year
All sexes
Interventional
Not applicable
Germantown, Tennessee, 38138, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subjects will receive non-opiate medications for pain control
Subjects will receive opiate based medications for pain control
Time frame: postoperative day to two week visit
opiate pill count
Time frame: two week to six week visit
opiate pill count
Time frame: six week to twelve week visit
opiate pill count
Time frame: postoperative day to two week visit
Patient reported pain score from 0 to 10 where 0 is no pain and 10 is the most pain
Time frame: six week visit
Patient reported pain score from 0 to 10 where 0 is no pain and 10 is the most pain
Time frame: twelve week visit
Patient reported pain score from 0 to 10 where 0 is no pain and 10 is the most pain
Time frame: postoperative day to two week visit
monitoring for safety events
Time frame: two week to six week visit
monitoring for safety events
Time frame: six week to twelve week visit
monitoring for safety events
Time frame: postoperative day to two week visit
patient reported satisfaction with pain management from 0 to 10 where 0 is very unsatisfied and 10 is very satisfied
Time frame: two week to six week visit
patient reported satisfaction with pain management from 0 to 10 where 0 is very unsatisfied and 10 is very satisfied
Time frame: six week to twelve week visit
patient reported satisfaction with pain management from 0 to 10 where 0 is very unsatisfied and 10 is very satisfied
Campbell Clinic
Other
Prospective, Randomized, Controlled Trial of an Opiate Sparing Protocol Versus Standard Opiate Based Protocol Following Open Reduction Internal Fixation of Distal Radius Fractures
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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