OLP to Manage Pain in TJA: A Feasibility Study

• Status: Not yet recruiting
• Trial end date: 2022-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Persistent opioid abuse presents a common yet under-recognized problem given the decreasing rates of morbidity and mortality following common elective surgical procedures, like total joint arthroplasty (TJA). Each year around 33-70% of patients seeking surgical procedures in the U.S. transition to persistent opioid use following elective surgery (such as TJA), primarily prescribed for post-operative pain management. Further, these patients are more likely to demand greater doses and for longer duration post-surgery due to maladaptive neurologic changes occurring in key areas of the brain. The purpose of this study is to see if it is feasible to use OLP (open label placebo) for post-operative pain management in the post TJA setting. In addition the investigators will also collect pilot data to compare key outcome measures (patient reported physical function related to osteoarthritis of the hip and knee, pain score, and health-related quality of life will be assessed) between the placebo and the Treatment-As-Usual (TAU) group over a 90-day post-operative period.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Alabama at Birmingham

Criteria

Inclusion Criteria:

• Participants eligible to undergo the TJA surgical procedure

Exclusion Criteria:

• Participants who are not eligible to undergo the TJA surgical procedure i.e. (participants who are morbidly obese or with comorbidities that make them ineligible for the surgery)