Prospective Evaluation of Post-operative Pain Management Using Exparel in the Pediatric Population
Texas Scottish Rite Hospital for Children
Summary
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
Description
This is a single institution, prospective, single-blinded (patient) randomized controlled trial to investigate the pain-control efficacy and patient reported pain outcomes of Exparel use in youth receiving MPFL Reconstruction. Participants will be randomized into two groups, Exparel + Marcaine or Marcaine-only. To be included, participants must be aged 10+ years at the time of surgery and present with an injury requiring an isolated MPFL reconstruction. Data will be collected from the patient's electronic medical record and from Oberd. Data collected will include age, height, weight, surgical…
Eligibility
- Age range
- 13–21 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Patient pregnancy * Inability to provide assent or legally appointed representative t…
Interventions
- DrugExparel
Patients will be randomized to receive Exparel intraoperatively via local infiltration.
Location
- Texas Scottish Rite Hospital for ChildrenFrisco, Texas