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Recruiting NCT05690282

Comparing Perioperative Outcomes in Pain Control

Conditions: Post-operative Pain

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: 1
Phase: PHASE4
Enrollment: 100
Sponsor: University of California, San Diego

Location: United States

Summary

This project consists of a randomized controlled study design. Study candidates will include all patients 18 years or older, who were evaluated at UCSD and found to have an orthopaedic injury requiring surgery. Patients who consent to study participation will be randomized to receive either the multimodal pain management protocol or standard oral hydrocodone-acetaminophen for post-operative pain management. Data on opioid usage, pain control, and functional status will be collected for each participant. After 3 years of data collection, investigators will analyze this data to provide further insight in determining appropriateness of pain regimens that reduce the overall opioid consumption. Given the widespread opioid epidemic, it is imperative to develop alternative means to appropriately manage pain in orthopaedic surgery patients.

Eligibility Criteria

Inclusion Criteria:Orthopaedic injury requiring surgeryEvaluation and treatment at UCSDAge 18years or olderAbility to understand the content of the patient information/Informed Consent FormSigned and dated Institutional Review Board (IRB) approved written informed consentExclusion Criteria:PolytraumaAny not medically managed severe systemic diseaseTheir doctor has decided that it is in the patient's best interest to receive pain management regimen of one type vs. the other.The patient prefers one type of pain management protocol and is not willing to be randomized.Recent history of substance abuse (i.e. recreational drugs, alcohol) that would preclude reliable assessment or confound pain controlPregnancy or women planning to conceive within the subject participation period (1 year)o Pregnancy will be self-reported and no test will be performed to test for it.PrisonerParticipation in any other pharmacologic or medicinal product study within the previous month that could influence the results of this study.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05690282). StuddyBuddy aggregates publicly available trial information.