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

a study on Periacetabular Osteotomy Opiates

Summary

Eligibility
for people ages 13-40 (full criteria)
Location
at San Francisco, California
Dates
study started
study ends around
Principal Investigator
by Mohammad Diab, MD
Headshot of Mohammad Diab
Mohammad Diab

Description

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.

Official Title

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

Keywords

Periacetabular Osteotomy, Opiates, Therapeutics

Eligibility

You can join if…

Open to people ages 13-40

  • 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.

You CAN'T join if...

  • 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

Location

  • UCSF accepting new patients
    San Francisco California 94114 United States

Lead Scientist at UCSF

  • Mohammad Diab, MD
    Dr. Mohammad Diab is a Professor in the Department of Orthopaedic Surgery and the Department of Pediatrics at UCSF. Dr. Diab sees children and adolescents with the full spectrum of musculoskeletal conditions, from fractures to infections to bone deformity to congenital anomalies to neuromuscular disorders to skeletal dysplasias.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT07373210
Study Type
Interventional
Participants
Expecting 64 study participants
Last Updated
Contact us about this trial