Can PLIA Reduce Early Post-operative Pain After PAO Surgery?
ConditionHip Dysplasia
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age13-50
SponsorMichael C Willey
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Adolescent or young adult diagnosed with hip dysplasia indicated for PAO at University of Iowa Hospital and Clinics.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Ropivacaine, Epinephrine, Ketorolac, NaCl (Saline)
Combination productWeight 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
Treatment groups
120 Participants
are divided into 3 treatment groupsGroup A: ControlNo intervention 0 interventions
Group B: Post ClosureActive comparator 1 intervention
Group C: Throughout ProcedureActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 op2
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.3
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.4
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.Secondary outcomes
1
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
Preoperative2
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
Preoperative3
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
PreoperativeSponsors and contacts
Click on the lead sponsor to view all of their trials.
Michael C Willey
Lead sponsor
University of Iowa
Sponsor institution
Northwestern University
Collaborator
Source ClinicalTrials.gov