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

Part of paid clinical trials in Iowa City, Iowa.

Sponsor
Michael C Willey
Study ID
NCT06519955
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

  • Hip Dysplasia

Eligibility Criteria

Sex
ALL
Age
13 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • Ropivacaine, Epinephrine, Ketorolac, NaCl (Saline) — COMBINATION_PRODUCT
    Weight 50-74.9 kg: * ropivacaine 100mg/epinephrine 50 mcg/ketorolac 15mg in NaCl 0.9% 60mL * 2 vials of this for 120mL total Weight 75-99.9 kg: * Ropivacaine 150mg/epinephrine 100 mcg/ketorolac 15mg in NaCl 0.9% 60mL * 2 vials of this for 120mL total Weight 100+ kg: * Ropivacaine 200mg/epinephrine 150 mcg/ketorolac 15 mg in NaCl 0.9% 60mL * 2 vials of this for 120mL total

Study Details

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.

Key Dates

Start date
Oct 3, 2024
Status verified
Apr 2026
Primary completion
May 31, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • No Intervention: Control
    No medication administration. Standard of care medications will be offered.
  • Active Comparator: Post Closure
    Once the fascia has been closed, the PLIA will be administered using a pediatric catheter.
  • Active Comparator: Throughout Procedure
    The injection will be performed throughout the surgical procedure.

Primary Outcome Measure

Post-operative pain after periacetabular osteotomy. [ Time Frame: Post Anesthesia Care Unit (PACU), 24 hours post op ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Iowa Health CareIowa CityIowa52242
Ashley Kochuyt
[email protected]
319-384-5101

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By research site
University of Iowa Health Care· Iowa City, IA

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