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

April 28, 2026 updated by: University of California, San Francisco

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94158
        • Recruiting
        • University of California San Francisco
        • Principal Investigator:
          • Mohammad Diab, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Other: 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.
Other: 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.
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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
COLP participants will take one placebo pill with their standard post-operative medications. TAU participants will take standard post-operative medications. Opioid Daily Diary and surveys will compare the opioid amount.
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.
Pain perception will be measured by surveys.
Admission to 6 weeks post-operatively.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of time in days following surgery until patients establish independence with physical therapy
Time Frame: Post-operative Day 1 to 6 weeks.
Participants will be treated by physical therapy services after surgery until their physical therapist determines that services are no longer needed.
Post-operative Day 1 to 6 weeks.
Length of hospital stay
Time Frame: Admission to discharge, up to 6 weeks
Participants will be admitted to the hospital following surgery until cleared for discharge.
Admission to discharge, up to 6 weeks
Time to return to school or work
Time Frame: Discharge to first day of school or work, up to 6 weeks post-operatively
Participants will be asked to record date they have returned to school or work after surgery. The amount of time it takes to return, may determine if they are struggling with pain.
Discharge to first day of school or work, up to 6 weeks post-operatively
Urinary retention
Time Frame: During hospitalization, until discharge, up to 6 weeks
Participants will be assessed in hospital to determine whether or not they experience urinary retention post surgery, a potential side effect of opioid consumption.
During hospitalization, until discharge, up to 6 weeks
Constipation & First Bowel Movement
Time Frame: Post-operatively to first flatus and bowel movement, up to 6 weeks
Participants will record the first time they flatulate, the number of days until their first bowel movement after surgery to assess constipation, a potential side effect of opioid consumption.
Post-operatively to first flatus and bowel movement, up to 6 weeks
Number of postoperative clinical contacts in COLP compared to TAU
Time Frame: Post-operatively to 6 weeks
The number of interactions or communication between the participant and medical providers. This includes follow-up visits, phone calls, or messages.
Post-operatively to 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Investigators

  • Principal Investigator: Mohammad Diab, MD, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2026

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

March 31, 2028

Study Registration Dates

First Submitted

January 12, 2026

First Submitted That Met QC Criteria

January 22, 2026

First Posted (Actual)

January 28, 2026

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-44743

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Opiates

Clinical Trials on Open-Label Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Costa Rica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe