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

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified March 2026 by Michael C Willey
Sponsor
Michael C Willey
Information Provided by (Responsible Party)
Michael C Willey
Clinicaltrials.gov Identifier
NCT06519955
Other Study ID Numbers:
202311233
First Submitted
July 14, 2024
First Posted
July 24, 2024
Last Update Posted
April 16, 2026
Last Verified
March 2026

ClinicalTrials.gov processed this data on April 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

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.

Condition or DiseaseIntervention/Treatment
Hip Dysplasia
Combination Product: Ropivacaine, Epinephrine, Ketorolac, NaCl (Saline)Combination Product: Ropivacaine, Epinephrine, Ketorolac, NaCl (Saline)

Study Design

Study TypeInterventional
Actual Enrollment120 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingSingle
Primary PurposeSupportive Care
Official TitlePeri-incisional Local Infiltration to Improve Pain Control After Periacetabular Osteotomy
Study Start DateOctober 2, 2024
Actual Primary Completion DateApril 30, 2026
Actual Study Completion Date2mos 4w from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Control
No medication administration. Standard of care medications will be offered.
Post Closure
Once the fascia has been closed, the PLIA will be administered using a pediatric catheter.
Combination Product: 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
Throughout Procedure
The injection will be performed throughout the surgical procedure.
Combination Product: 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

Outcome Measures

Primary Outcome Measures
  1. Post-operative pain after periacetabular osteotomy.
    Severity of pain will be measured by collection of the visual analog scale (VAS) for pain. Scale of 1-10.
  2. Pain medication usage after periacetabular osteotomy.
    The amount of pain medications taken will be measured using morphine equivalent dosing (MED).
  3. The impact of timing of PLIA administration on post-operative pain.
    The mean VAS pain will be compared between the different study groups. Scale of 1-10.
  4. The impact of timing of PLIA administration on MED.
    The mean MED will be compared between the different study groups.
Secondary Outcome Measures
  1. Assessment on depression (PHQ-9)
    A scale to measure depression will be collected to determine the impact on early post-operative pain. Scale of 0-27.
  2. General Self-Efficacy Scale (GSE)
    Scale on self-efficacy will be collected to determine the impact on early post-operative pain. Scale of 10-40
  3. Pain Resilience Scale.
    Scale on pain resilience (grit) will be collected to determine the impact on early post-operative pain. The scale provides two scores, Behavioral Perseverance on a scale of 0-20 and Cognitive/Affective Positivity on a scale of 0-36.

Eligibility Criteria

Ages Eligible for Study(Child, Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersYes
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

Contacts and Locations

Sponsors and CollaboratorsMichael C Willey
Locations
University of Iowa Health Care | Iowa City Iowa, United States, 52242