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

NCT06519955 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 202311233
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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. 1.Does PLIA impact post-operative pain after PAO?
2. 2.Does PLIA impact pain medication usage as measured by morphine equivalent dosing (MED) after PAO?
3. 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.

Conditions

Hip Dysplasia

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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.

  Post Anesthesia Care Unit (PACU), 24 hours post op

• Pain medication usage after periacetabular osteotomy.

  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.

  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.

  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 Outcomes (3)

• Assessment on depression (PHQ-9)

  Preoperative

• General Self-Efficacy Scale (GSE)

  Preoperative

• Pain Resilience Scale.

  Preoperative

Study Arms (3)

Control

NO INTERVENTION

No medication administration. Standard of care medications will be offered.

Post Closure

ACTIVE COMPARATOR

Once the fascia has been closed, the PLIA will be administered using a pediatric catheter.

Combination Product: Ropivacaine, Epinephrine, Ketorolac, NaCl (Saline)

Throughout Procedure

ACTIVE COMPARATOR

The injection will be performed throughout the surgical procedure.

Combination Product: Ropivacaine, Epinephrine, Ketorolac, NaCl (Saline)

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

Post Closure; Throughout Procedure

Eligibility Criteria

• Age: 13 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Michael C Willey: lead
• Northwestern University: collaborator

Study Sites (1)

University of Iowa Health Care

Iowa City, Iowa, 52242, United States

RECRUITING

MeSH Terms

Conditions

Hip Dislocation

Interventions

Ropivacaine; Epinephrine; Ketorolac; Sodium Chloride

Condition Hierarchy (Ancestors)

Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Hip Injuries

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Ashley S Kochuyt

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Orthopedics and Rehabilitation

Study Record Dates

• First Submitted: July 15, 2024
• First Posted: July 25, 2024
• Study Start: October 3, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Locations

US (1)