RecruitingNot ApplicableNCT07373210

Open-label Placebo for Pain Management in Adolescents and Young Adults Undergoing Bernese Periacetabular Osteotomy

Conditioning, Open-label Placebo for Pain Management in Adolescents and Young Adults Undergoing Bernese Periacetabular Osteotomy (PAO)


Sponsor

University of California, San Francisco

Enrollment

64 participants

Start Date

Mar 1, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 13 YearsMax Age: 40 Years

Inclusion Criteria4

  • 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 Criteria4

  • 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

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Interventions

OTHEROpen-Label Placebo

One placebo tablet will be taken with each oral opioid dose, 5mg Oxycodone, 6 times per day, beginning on post-operative day 1.

OTHERTreatment as usual

Treatment As Usual (TAU) participants will receive their standard opioid dose, 5mg Oxycodone pill, 6 times a day beginning on post-operative day 1.


Locations(1)

University of California San Francisco

San Francisco, California, United States

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NCT07373210