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NCT Number: NCT07373210

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

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.

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Key information

Conditions

Periacetabular Osteotomy Opiates

Age range

13 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California San Francisco

San Francisco, California, 94158, United States

Location status: Recruiting

Location contact

Mohammad Diab, MD

PRINCIPAL_INVESTIGATOR

Tripta Rughwani

CONTACT

[email protected]

415-353-4701

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

open-label placebo

Other

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

Other

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 outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Tripta Rughwani

CONTACT

[email protected]

415-353-4701

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

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

Acronym: COLP PAO

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jan 28, 2026
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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