A Phase 2/3 interventional study of Ropivacaine, Epinephrine, Ketorolac, NaCl (Saline) in Hip Dysplasia, sponsored by Michael C Willey. Completed at 1 site in United States. Open to participants aged 13 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-07.
Sponsored by Michael C Willey · Phase 2/3, Interventional, and Supportive care
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:
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.
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.
107 studies on the registry are indexed under Hip Dislocation; 36 are open to participants now.
This study's enrollment of 121 is above the median of 86 across 64 interventional studies indexed under Hip Dislocation.
Browse Hip Dislocation studies →Michael C Willey is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
No medication administration. Standard of care medications will be offered.
Once the fascia has been closed, the PLIA will be administered using a pediatric catheter.
Combination Product: Ropivacaine, Epinephrine, Ketorolac, NaCl (Saline)
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
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.
Time frame: 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).
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.
The mean VAS pain will be compared between the different study groups. Scale of 1-10.
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.
The mean MED will be compared between the different study groups.
Time frame: Post Anesthesia Care Unit (PACU) to end of hospital stay, an average of 3 days.
Assessment on depression (PHQ-9)
A scale to measure depression will be collected to determine the impact on early post-operative pain. Scale of 0-27.
Time frame: Preoperative
General Self-Efficacy Scale (GSE)
Scale on self-efficacy will be collected to determine the impact on early post-operative pain. Scale of 10-40
Time frame: Preoperative
Pain Resilience Scale.
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.
Time frame: Preoperative
Ran from Oct 2024 to primary completion in May 2026, 19 months.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Michael C Willey