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Recruiting NCT06519955

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

Phase II / Phase III Interventional Hip Dysplasia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ropivacaine, Epinephrine, Ketorolac, NaCl (Saline).
Who it may be relevant to
Registry conditions: Hip Dysplasia. Basic parameters: 13 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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.

Interventions

  • 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

Primary outcome measures

  • 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.]
Secondary outcome measures (3)
  • Assessment on depression (PHQ-9) [Time frame: Preoperative]
  • General Self-Efficacy Scale (GSE) [Time frame: Preoperative]
  • Pain Resilience Scale. [Time frame: Preoperative]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

United States · 1 center
  • University of Iowa Health Care — Iowa City

Identifiers

NCT: NCT06519955 · 202311233

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗