About this trial
The goal of this randomized clinical trial is to determine if administration of Exparel via local infiltration for medial patellofemoral ligament (MPFL) reconstruction procedures in pediatric orthopaedic sports medicine patients provides significant pain relief and decreased narcotic use. The main questions it aims to answer are:
* Does Exparel significantly reduce Visual Analog Scale (VAS) pain scores and pain levels up to one week postoperatively? * Does Exparel significantly decrease narcotic use (number of pills taken) up to one week postoperatively?
Researchers will compare the pain outcomes and narcotic use of patients who receive Exparel and Marcaine via local infiltration to those of patients who receive only Marcaine via local infiltration for their MPFL reconstruction surgery. The goal is to understand if there is a significant difference in patient pain outcomes and narcotic use outside the first 24 hours postoperatively.
Participants will:
* receive either Exparel + Marcaine intraoperatively or Marcaine only intraoperatively during their MPFL reconstruction surgery * receive and complete questionnaires at postoperative days 1, 4, and 7 regarding their pain scores, levels, and outcomes, effective pain treatments, overall pain interference, narcotic use (number of pills taken), and overall pain treatment satisfaction * receive and complete secondary outcome measures of functional and psychological outcomes regarding their MPFL reconstruction surgery at postoperative day 1
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Must be aged 13+ years at time of surgery
Must present with injury requiring an isolated MPFL Reconstruction
Ability to provide assent, legally appointed representative available to provide informed consent
Disqualifiers
Patient <13 years old
Requires fracture repair or another non-standardized surgery
Any MPFL Reconstruction that requires the use of arthrotomy or a tibial tubercle osteotomy
Any lower extremity procedure that is not an isolated MPFL Reconstruction
Trial design
Parallel
Treatments tested in this trial
Exparel
DrugPatients will be randomized to receive Exparel intraoperatively via local infiltration.
Treatment groups
Trial outcomes
Primary outcomes
Visual Analog Scale (VAS) Wong-Baker Face Pain Scale
Scale with evocative faces from 0-10 (0 = No Pain, 10 = Worst Pain Possible) that assists children in communicating about their pain
Visual Analog Scale (VAS) 10-centimeter line 0-10 Numeric Pain Intensity Scale
Sliding scale from 0-10 (0 = No Pain, 10 = Pain as bad as it could possibly be) that enables a more accurate estimate of pain score
Scottish Rite for Children-developed pain questionnaire
Institutional questionnaire that asks how many narcotic pills the patient has taken (0 - 12 pills), if their pain is controlled, treatments that lessens their pain, term that best describes their pain, how much their pain has interfered with daily tasks and overall mood, and sleep interference due to pain.
Pain Management Patient Satisfaction questionnaire
Questionnaire that asks how satisfied patients are with their pain treatment (0 = Not Satisfied, 10 = Extremely Satisfied), if they contacted their physician due to ineffective pain treatment, how helpful the information provided for pain treatment was (0 = Not Helpful, 10 = Extremely Helpful), and a free response section to explain why they were not satisfied with their pain treatment and if they have any additional comments or suggestions based on their pain treatment.
Secondary outcomes
Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Scale v1.0 - Global Health 7+2
Questionnaire of outcomes regarding their overall health (scored 20-80, 20 = poor and 80 = good).
Sponsors and contacts
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