Conditioning, Open-label Placebo for Pain Management in Adolescents and Young Adults Undergoing Bernese Periacetabular Osteotomy (PAO)
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
In this randomized controlled trial, 64 participants undergoing PAO at UCSF will be enrolled and randomized to receive either COLP plus treatment as usual (TAU) or TAU alone. Patients in the COLP arm will receive placebo pills alongside prescribed opioids and at scheduled intervals, beginning on postoperative day one. Weekly follow-up will be conducted for six weeks postoperatively via remote surveys and video visits.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 13
Maximum Age: 40
Healthy Volunteers: f
View:
• Aged 13 to 40 years old, and
• Undergo primary Bernese Periacetabular osteotomy (PAO) for symptomatic developmental dysplasia of the hip (DDH), and
• Opioid-naïve prior to operation, and
• Capable of completing study procedures, including daily pain and medication diaries as well as weekly questionnaires.
Locations
United States
California
University of California San Francisco
RECRUITING
San Francisco
Contact Information
Primary
Tripta Rughwani
tripta.rughwani@ucsf.edu
415-353-4701
Time Frame
Start Date: 2026-03
Estimated Completion Date: 2028-03-31
Participants
Target number of participants: 64
Treatments
Experimental: Open-label Placebo (COLP)
One placebo tablet will be taken with each oral opioid dose, 5mg Oxycodone, 6 times per day, beginning on post-operative day 1.
Experimental: Treatment As Usual (TAU)
Treatment As Usual (TAU) participants will receive their standard opioid dose, 5mg Oxycodone pill, 6 times a day beginning on post-operative day 1.
Related Therapeutic Areas
Sponsors
Leads: University of California, San Francisco