Recruiting

COLP with TAU

Sponsor:

UCLA

Code:

NCT07373210

Conditions

Periacetabular Osteotomy

Opiates

Eligibility Criteria

Sex: All

Age: 13 - 40

Healthy Volunteers: Not accepted

Interventions

Open-Label Placebo

Treatment as usual

Study Details

Brief 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.

Conditions

Periacetabular Osteotomy

Opiates

Study ID

NCT07373210

Start date

Dec, 2026

Status verified date

Apr, 2026

Completion date

Mar 31, 2028

Anticipated

Primary completion date

Mar 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13 - 40

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

64 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Open-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.

Treatment 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.

Primary outcome measure

  • Conditioning + Open-Label Placebo (COLP) results in significantly reduced opioid consumption compared with Treatment as Usual (TAU) [ Time Frame: Admission to 6 weeks post-operatively ]
  • To determine if 6 weeks of COLP results in reduced pain perception compared with TAU. [ Time Frame: Admission to 6 weeks post-operatively. ]

Central Contacts and Locations

Central contacts

Tripta Rughwani

415-353-4701tripta.rughwani@ucsf.edu

Locations

University of California San Francisco

Recruiting

San Francisco, California, United States, 94158

Contacts

Tripta Rughwani

415-353-4701tripta.rughwani@ucsf.edu

Principal Investigator:

Mohammad Diab, MD

More Information

Sponsor

University of California, San Francisco

Last update posted

Apr 29, 2026

Last verified

Apr, 2026

Keywords

  • periacetabular osteotomy
  • opiates

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2026-04-29.