Recruiting
Phase 2
Phase 3

PLIA

Sponsor:

Michael C Willey

Code:

NCT06519955

Conditions

Hip Dysplasia

Eligibility Criteria

Sex: All

Age: 13 - 50

Healthy Volunteers: Accepted

Interventions

Ropivacaine, Epinephrine, Ketorolac, NaCl (Saline)

Study Details

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.

Conditions

Hip Dysplasia

Study ID

NCT06519955

Start date

Oct 3, 2024

Status verified date

Apr, 2026

Completion date

Sep, 2026

Anticipated

Primary completion date

May, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13 - 50

Healthy Volunteers: Accepted

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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

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.

Interventions

Ropivacaine, Epinephrine, Ketorolac, NaCl (Saline)

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

Primary outcome measure

  • Post-operative pain after periacetabular osteotomy. [ Time Frame: Post Anesthesia Care Unit (PACU), 24 hours post op ]
  • Pain medication usage after periacetabular osteotomy. [ Time Frame: Post Anesthesia Care Unit (PACU) to end of hospital stay, an average of 3 days. ]
  • The impact of timing of PLIA administration on post-operative pain. [ Time Frame: Post Anesthesia Care Unit (PACU) to end of hospital stay, an average of 3 days. ]
  • The impact of timing of PLIA administration on MED. [ Time Frame: Post Anesthesia Care Unit (PACU) to end of hospital stay, an average of 3 days. ]

Central Contacts and Locations

Central contacts

Ashley S Kochuyt

319-384-5101ashley-kochuyt@uiowa.edu

Locations

University of Iowa Health Care

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Ashley Kochuyt

319-384-5101ashley-kochuyt@uiowa.edu

More Information

Sponsor

Michael C Willey

Last update posted

Apr 17, 2026

Last verified

Apr, 2026

Keywords

  • Hip Dysplasia
  • Periacetabular Osteotomy
  • PLIA
  • Peri-Incisional Local Infiltrative Anesthesia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Michael C Willey on 2026-04-17.