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

University of California San Francisco (UCSF)

Status: Enrolling

Conditions: Opiates; Periacetabular Osteotomy

Treatments: Other: Open-Label Placebo; Other: Treatment as usual

Study type: Interventional

Funder types: Other

Identifiers

NCT07373210

25-44743

Details and patient eligibility

About

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.

Enrollment: 64 estimated patients

Sex: All

Ages: 13 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

Open-label Placebo (COLP)

Experimental group

Description:

One placebo tablet will be taken with each oral opioid dose, 5mg Oxycodone, 3 times per day, beginning on post-operative day 1.

Treatment:

Other: Treatment as usual

Other: Open-Label Placebo

Treatment As Usual (TAU)

Experimental group

Description:

Treatment As Usual (TAU) participants will receive their standard opioid dose, 5mg Oxycodone pill, three times a day beginning on post-operative day 1.

Treatment:

Other: Treatment as usual