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

Last updated: December 3, 2024
Sponsor: Michael C Willey
Overall Status: Active - Recruiting

Phase

2/3

Condition

N/A

Treatment

Ropivacaine, Epinephrine, Ketorolac, NaCL

Ropivacaine, Epinephrine, Ketorolac, NaCl (Saline)

Clinical Study ID

NCT06519955
202311233
  • Ages 13-50
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adolescent or young adult diagnosed with hip dysplasia indicated for PAO atUniversity of Iowa Hospital and Clinics.

Exclusion

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 beexcluded

Study Design

Total Participants: 120
Treatment Group(s): 2
Primary Treatment: Ropivacaine, Epinephrine, Ketorolac, NaCL
Phase: 2/3
Study Start date:
October 03, 2024
Estimated Completion Date:
September 30, 2026

Study 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.

Connect with a study center

  • University of Iowa Health Care

    Iowa City, Iowa 52242
    United States

    Active - Recruiting

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