Open-label placebo plus usual care for pain after Bernese periacetabular osteotomy
Conditioning, Open-label Placebo for Pain Management in Adolescents and Young Adults Undergoing Bernese Periacetabular Osteotomy (PAO)
This test will see if giving open-label placebo pills alongside usual care helps adolescents and young adults (ages 13–40) manage post-operative pain and reduce opioid use after Bernese periacetabular osteotomy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 13 Years to 40 Years |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT07373210 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial will enroll 64 opioid‑naive patients aged 13–40 undergoing primary Bernese periacetabular osteotomy for symptomatic developmental dysplasia of the hip. Participants are randomized to receive contextualized open‑label placebo (COLP) pills in addition to treatment as usual (TAU) or TAU alone, with placebo pills started on postoperative day one alongside prescribed opioids at scheduled intervals. Daily pain and medication diaries and weekly remote surveys and video visits will be collected for six weeks after surgery to track pain scores and opioid consumption. The trial excludes patients with prior opioid use, revision or concurrent major surgery, substance use disorders, cognitive/physical impairments that prevent participation, and those who are pregnant or planning pregnancy.
Who should consider this trial
Good fit: Ideal candidates are opioid‑naive adolescents and young adults (13–40) having a primary Bernese PAO for symptomatic DDH who can complete daily pain/medication diaries and weekly remote follow‑up.
Not a fit: Patients with prior opioid use, substance use disorders, revision or concurrent major surgery, significant cognitive or physical impairments, or pregnancy are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this approach could reduce opioid use and related side effects while maintaining adequate pain control after PAO.
How similar studies have performed: Open‑label placebo interventions have shown promising but variable benefits for some pain conditions in prior studies, though their use specifically after PAO is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
San Francisco, California
- University of California San Francisco — San Francisco, California, United States (Recruiting)
Study contacts
- Principal investigator: Mohammad Diab, MD — University of California, San Francisco
- Study coordinator: Tripta Rughwani
- Email: tripta.rughwani@ucsf.edu
- Phone: 415-353-4701
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.