Conditioning, Open-label Placebo for Pain Management in Adolescents and Young Adults Undergoing Bernese Periacetabular Osteotomy (PAO)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- Conditioning + Open-Label Placebo (COLP) results in significantly reduced opioid consumption compared with Treatment as Usual (TAU)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 13 Years to 40 Years (Child, Adult)
- 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
Arms & Interventions
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.
Intervention: Open-Label Placebo (Other)
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.
Intervention: Treatment as usual (Other)
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.
Intervention: Treatment as usual (Other)
Outcomes
Primary Outcomes
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.
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
- Duration of time in days following surgery until patients establish independence with physical therapy(Post-operative Day 1 to 6 weeks.)
- Length of hospital stay(Admission to discharge, up to 6 weeks)
- Time to return to school or work(Discharge to first day of school or work, up to 6 weeks post-operatively)
- Urinary retention(During hospitalization, until discharge, up to 6 weeks)
- Constipation & First Bowel Movement(Post-operatively to first flatus and bowel movement, up to 6 weeks)
- Number of postoperative clinical contacts in COLP compared to TAU(Post-operatively to 6 weeks)