NCT07373210NARecruiting
Open-label Placebo for Pain Management in Adolescents and Young Adults Undergoing Bernese Periacetabular Osteotomy
University of California, San Francisco
Start Date
12/1/2026
Completion Date
3/31/2028
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 Criteria
Age Range: 13 years to 40 years
Inclusion Criteria:
* 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.
Exclusion Criteria:
* Undergoing PAO revision or any concurrent major surgical procedure
* History of opioid use, substance use disorders, or alcohol abuse
* Those with cognitive or physical impairments that would interfere with providing their own consent and the completion of study-related tasks
* Pregnant individuals or those planning to become pregnant during the study period
Interventions
OTHER
Open-Label Placebo
OTHER
Treatment as usual
Conditions
Periacetabular OsteotomyOpiates
Locations
University of California San Francisco
San Francisco, California 94158
United States