Hip DysplasiaPhase 2/3PILA PAONCT06519955
Can PLIA Reduce Early Post-operative Pain After PAO Surgery?
A Phase 2/3 study testing Ropivacaine, Epinephrine, Ketorolac, NaCl (Saline) in people with Hip Dysplasia, run by Michael C Willey at 1 site in United States.
Trial 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. Does PLIA impact post-operative pain after PAO? 2. Read more about this study
- Who is it for?
- Ages 13 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Hip Dysplasia
- What is being tested?
- Ropivacaine, Epinephrine, Ketorolac, NaCl (Saline)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2024to 1 Sep 2026
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Adolescent or young adult diagnosed with hip dysplasia indicated for PAO at University of Iowa Hospital and Clinics.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa Health Care
Iowa City, Iowa, 52242
About this study
Official title: Peri-incisional Local Infiltration to Improve Pain Control After Periacetabular Osteotomy
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:
- Does PLIA impact post-operative pain after PAO?
- Does PLIA impact pain medication usage as measured by morphine equivalent dosing (MED) after PAO?
- 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.
Read the 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.
- Conditions
- Hip Dysplasia
- Being tested
- Ropivacaine, Epinephrine, Ketorolac, NaCl (Saline)
- Keywords
- Hip Dysplasia, Periacetabular Osteotomy, PLIA, Peri-Incisional Local Infiltrative Anesthesia
- Medical subject headings
- Hip Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Combination Product: Ropivacaine, Epinephrine, Ketorolac, NaCl (Saline) |
| Throughout Procedure | Active comparator | The injection will be performed throughout the surgical procedure. Receives: Combination Product: Ropivacaine, Epinephrine, Ketorolac, NaCl (Saline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Post Anesthesia Care Unit (PACU) to end of hospital stay, an average of 3 days.
Secondary outcomes (3)
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.
Measured: 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
Measured: 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.
Measured: Preoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start3 Oct 2024
- Primary completion26 May 2026
- Study completion1 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip DysplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michael C Willey
- Sponsor type
- University, hospital or other
- Collaborators
- Northwestern University
- Responsible party
- Sponsor-investigator, Michael C Willey, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06519955
- Sponsor's protocol ID
- 202311233
- Acronym
- PILA PAO
- Status last verified
- Oct 2026
- First submitted
- 15 Jul 2024
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peri-incisional Local Infiltration to Improve Pain Control After Periacetabular Osteotomy
- ClinicalTrials.gov ID
- NCT06519955
- Acronym / sponsor ID
- PILA PAO / 202311233
- Conditions
- Hip Dysplasia
- Keywords
- Hip Dysplasia, Periacetabular Osteotomy, PLIA, Peri-Incisional Local Infiltrative Anesthesia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Michael C WilleyUniversity, hospital or other
- Collaborators
- Northwestern University
- Study start
- 3 Oct 2024 (actual)
- Primary completion
- 26 May 2026 (actual)
- Study completion
- 1 Sep 2026 (actual)
- First posted
- 25 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does PLIA impact post-operative pain after PAO?
- Does PLIA impact pain medication usage as measured by morphine equivalent dosing (MED) after PAO?
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No medication administration. Standard of care medications will be offered. |
| Post Closure | Active comparator | Combination Product: Ropivacaine, Epinephrine, Ketorolac, NaCl (Saline)Once the fascia has been closed, the PLIA will be administered using a pediatric catheter. |
| Throughout Procedure | Active comparator | Combination Product: Ropivacaine, Epinephrine, Ketorolac, NaCl (Saline)The injection will be performed throughout the surgical procedure. |
Who may qualify
- Ages
- 13 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Adolescent or young adult diagnosed with hip dysplasia indicated for PAO at University of Iowa Hospital and Clinics.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Combination product | Post Closure, Throughout Procedure |
Primary outcome
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.
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).
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.
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.
3 secondary outcomes
Assessment on depression (PHQ-9)
Time frame: Preoperative
General Self-Efficacy Scale (GSE)
Time frame: Preoperative
Pain Resilience Scale.
Time frame: Preoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ropivacaine, Epinephrine, Ketorolac, NaCl (Saline) in people with Hip Dysplasia, run by Michael C Willey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative pain after periacetabular osteotomy. (time frame: Post Anesthesia Care Unit (PACU), 24 hours post op). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.