Can PLIA Reduce Early Post-operative Pain After PAO Surgery? (PILA PAO)

Michael C Willey

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Hip Dysplasia

Treatments: Combination Product: Ropivacaine, Epinephrine, Ketorolac, NaCl (Saline)

Study type: Interventional

Funder types: Other

Identifiers

NCT06519955

202311233

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 13 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 3 patient groups

Control

No Intervention group

Description:

No medication administration. Standard of care medications will be offered.

Post Closure

Active Comparator group

Description:

Once the fascia has been closed, the PLIA will be administered using a pediatric catheter.

Treatment:

Combination Product: Ropivacaine, Epinephrine, Ketorolac, NaCl (Saline)

Throughout Procedure

Active Comparator group

Description:

The injection will be performed throughout the surgical procedure.

Treatment:

Combination Product: Ropivacaine, Epinephrine, Ketorolac, NaCl (Saline)