Evaluation of Pain Management After Surgery When Using Exparel in the Pediatric Population
NCT Number: NCT06559215
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Medial Patellofemoral Ligament (MPFL) Reconstruction|Sports Injuries in Children|Analgesia|Pain, Postoperative
Interventions: DRUG: Exparel
Sponsor: Texas Scottish Rite Hospital for Children
Sex: ALL
Age: CHILD, ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2026-12
Locations: Texas Scottish Rite Hospital for Children, Frisco, Texas, 75034, United States

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

Primary Outcome Measures: 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, Postoperative days 1, 4, and 7|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, Postoperative days 1, 4, and 7|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., Postoperative days 1, 4, and 7|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., Postoperative day 7
Secondary Outcome Measures: 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)., Preoperatively and within one week postoperatively