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

April 14, 2026 updated by: Michael C Willey

Peri-incisional Local Infiltration to Improve Pain Control After Periacetabular Osteotomy

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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
Active Comparator: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative pain after periacetabular osteotomy.
Time Frame: Post Anesthesia Care Unit (PACU), 24 hours post op
Severity of pain will be measured by collection of the visual analog scale (VAS) for pain. Scale of 1-10.
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 amount of pain medications taken will be measured using morphine equivalent dosing (MED).
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 mean VAS pain will be compared between the different study groups. Scale of 1-10.
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.
The mean MED will be compared between the different study groups.
Post Anesthesia Care Unit (PACU) to end of hospital stay, an average of 3 days.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment on depression (PHQ-9)
Time Frame: Preoperative
A scale to measure depression will be collected to determine the impact on early post-operative pain. Scale of 0-27.
Preoperative
General Self-Efficacy Scale (GSE)
Time Frame: Preoperative
Scale on self-efficacy will be collected to determine the impact on early post-operative pain. Scale of 10-40
Preoperative
Pain Resilience Scale.
Time Frame: Preoperative
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.
Preoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Michael C Willey

Collaborators

Northwestern University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 3, 2024

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

July 15, 2024

First Submitted That Met QC Criteria

July 19, 2024

First Posted (Actual)

July 25, 2024

Study Record Updates

Last Update Posted (Actual)

April 17, 2026

Last Update Submitted That Met QC Criteria

April 14, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202311233

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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