Clinical trial NCT06519955: Can PLIA Reduce Early Post-operative Pain After PAO Surgery?
Official title: Peri-incisional Local Infiltration to Improve Pain Control After Periacetabular Osteotomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Hip Dysplasia
Keywords: Hip Dysplasia
Periacetabular Osteotomy
PLIA
Peri-Incisional Local Infiltrative Anesthesia
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: Northwestern University
First posted: 2024-07-25
Enrollment: 120
Sex: ALL
Minimum age (years): 13
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to compare different peri-incisional local infiltrative anesthesia (PLIA) methods in patients ages 13 to 50 undergoing a periacetabular osteotomy (PAO). The main questions to answer here are:

1. Does PLIA impact post-operative pain after PAO?
2. Does PLIA impact pain medication usage as measured by morphine equivalent dosing (MED) after PAO?
3. Does the timing of PLIA administration impact post-operative pain and MED after PAO? Participants will be asked to complete some surveys; demographics survey, General Self-Efficacy Scale (GSE) and the Pain Resilience Scale. All other information will be gathered from the patients medical chart.

Researchers will compare three groups. 1.) Patients who do not receive PLIA. 2.) Patients who receive PLIA after their incision is closed. 3.) Patients who receive PLIA throughout PAO.

Detailed description: Patients will be approached at their preoperative appointment. This is the only time researchers will conduct study related activities with patients. All other information will be gathered by chart review. Following consent, patients will be asked to complete surveys through REDCap® using a tablet or computer. These include a self-efficacy survey and a grit survey. Patients will then be randomized in a 1:1:1 ratio. 1.) Patients who do not receive PLIA. 2.) Patients who receive PLIA after their incision is closed. 3.) Patients who receive PLIA throughout PAO.

Patients will be blinded to which group they are in, meaning they will not know whether they received the injection or not. Patients may ask to be told what study group they were in at their standard-of-care, 3 month follow-up visit.

Following surgery, patients in all treatment arms will be provided with the same intravenous (patient-controlled analgesia) and oral pain medications scheduled as needed per standard of care.

The research team will review patient medical records to record narcotic use and visual analog scale (VAS) pain scores post-operatively until discharge from the hospital.

Eligibility criteria: Inclusion Criteria:

* Adolescent or young adult diagnosed with hip dysplasia indicated for PAO at University of Iowa Hospital and Clinics.

Exclusion Criteria:

* Unable to provide informed consent.
* Pregnant or breast-feeding individuals
* Prisoner or ward of the state
* Allergy or medical contradiction to any of the study medications
* Patients undergoing femoral osteotomy or surgical hip dislocation with PAO will be excluded

Primary outcomes:
measure: Post-operative pain after periacetabular osteotomy.
timeFrame: Post Anesthesia Care Unit (PACU), 24 hours post op
measure: Pain medication usage after periacetabular osteotomy.
timeFrame: Post Anesthesia Care Unit (PACU) to end of hospital stay, an average of 3 days.
measure: The impact of timing of PLIA administration on post-operative pain.
timeFrame: Post Anesthesia Care Unit (PACU) to end of hospital stay, an average of 3 days.
measure: The impact of timing of PLIA administration on MED.
timeFrame: Post Anesthesia Care Unit (PACU) to end of hospital stay, an average of 3 days.
Secondary outcomes:
measure: Assessment on depression (PHQ-9)
timeFrame: Preoperative
measure: General Self-Efficacy Scale (GSE)
timeFrame: Preoperative
measure: Pain Resilience Scale.
timeFrame: Preoperative
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa Health Care
state: Iowa
Study officials:
References: