Can PLIA Reduce Early Post-operative Pain After PAO Surgery?
NCT ID: NCT06519955
Last Updated: 2024-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
120 participants
INTERVENTIONAL
2024-10-03
2026-09-30
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Control
No medication administration. Standard of care medications will be offered.
No interventions assigned to this group
Post Closure
Once the fascia has been closed, the PLIA will be administered using a pediatric catheter.
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.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
13 Years
50 Years
ALL
Yes
Sponsors
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Northwestern University
OTHER
Michael C Willey
OTHER
Responsible Party
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Michael C Willey
Assistant Professor of Orthopedics and Rehabilitation
Locations
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University of Iowa Health Care
Iowa City, Iowa, United States
Countries
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Central Contacts
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Facility Contacts
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Ashley Kochuyt
Role: primary
Other Identifiers
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202311233
Identifier Type: -
Identifier Source: org_study_id