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

University of California, San Francisco64 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Periacetabular Osteotomy Opiates

Interventions

Eligibility

Sex: ALLMin age: 13 YearsMax age: 40 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Conditioning + Open-Label Placebo (COLP) results in significantly reduced opioid consumption compared with Treatment as Usual (TAU)

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.

Time frame: Admission to 6 weeks post-operatively

To determine if 6 weeks of COLP results in reduced pain perception compared with TAU.

Pain perception will be measured by surveys.

Time frame: Admission to 6 weeks post-operatively.

Secondary Outcomes

Duration of time in days following surgery until patients establish independence with physical therapy

Participants will be treated by physical therapy services after surgery until their physical therapist determines that services are no longer needed.

Time frame: Post-operative Day 1 to 6 weeks.

Length of hospital stay

Participants will be admitted to the hospital following surgery until cleared for discharge.

Time frame: Admission to discharge, up to 6 weeks

Time to return to school or work

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.

Time frame: Discharge to first day of school or work, up to 6 weeks post-operatively

Urinary retention

Participants will be assessed in hospital to determine whether or not they experience urinary retention post surgery, a potential side effect of opioid consumption.

Time frame: During hospitalization, until discharge, up to 6 weeks

Constipation & First Bowel Movement

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.

Time frame: Post-operatively to first flatus and bowel movement, up to 6 weeks

Number of postoperative clinical contacts in COLP compared to TAU

The number of interactions or communication between the participant and medical providers. This includes follow-up visits, phone calls, or messages.

Time frame: Post-operatively to 6 weeks