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

Purpose

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

Eligibility

Eligible Ages
Between 13 Years and 40 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

University of California San Francisco
San Francisco, California 94158
Contact:
Tripta Rughwani
415-353-4701
tripta.rughwani@ucsf.edu

More Details

Status
Recruiting
Sponsor
University of California, San Francisco

Study Contact

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