Opiates, Periacetabular Osteotomy
Conditions
Keywords
periacetabular osteotomy, opiates
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.
Interventions
OTHEROpen-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.
OTHERTreatment 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.
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to 40 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Conditioning + Open-Label Placebo (COLP) results in significantly reduced opioid consumption compared with Treatment as Usual (TAU) | 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. | Admission to 6 weeks post-operatively. | Pain perception will be measured by surveys. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of time in days following surgery until patients establish independence with physical therapy | Post-operative Day 1 to 6 weeks. | Participants will be treated by physical therapy services after surgery until their physical therapist determines that services are no longer needed. |
| Length of hospital stay | Admission to discharge, up to 6 weeks | Participants will be admitted to the hospital following surgery until cleared for discharge. |
| Time to return to school or work | Discharge to first day of school or work, up to 6 weeks post-operatively | 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. |
| Urinary retention | During hospitalization, until discharge, up to 6 weeks | Participants will be assessed in hospital to determine whether or not they experience urinary retention post surgery, a potential side effect of opioid consumption. |
| Constipation & First Bowel Movement | Post-operatively to first flatus and bowel movement, up to 6 weeks | 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. |
| Number of postoperative clinical contacts in COLP compared to TAU | Post-operatively to 6 weeks | The number of interactions or communication between the participant and medical providers. This includes follow-up visits, phone calls, or messages. |
Countries
United States
Contacts
CONTACTTripta Rughwani
PRINCIPAL_INVESTIGATORMohammad Diab, MD
University of California, San Francisco
Outcome results
None listed