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NCT Number: NCT06519955

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

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.

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Key information

Conditions

Hip Dysplasia Hip Dislocation Hip Injuries Joint Diseases Joint Dislocations Musculoskeletal Diseases Wounds and Injuries

Age range

13 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University of Iowa Health Care

Iowa City, Iowa, 52242, United States

Location status: Recruiting

Location contact

Ashley Kochuyt

CONTACT

[email protected]

319-384-5101

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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.

  2. 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).

  3. 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.

  4. 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.

Secondary outcomes

  1. 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.

  2. 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

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ashley S Kochuyt

CONTACT

[email protected]

319-384-5101

Sponsors and collaborators

Lead sponsor

Michael C Willey

Other

Collaborators

  • Northwestern University

Registry information

Official study title

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

Acronym: PILA PAO

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 25, 2024
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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