RecruitingPhase 2NCT06559215

Evaluation of Pain Management After Surgery When Using Exparel in the Pediatric Population

Prospective Evaluation of Post-operative Pain Management Using Exparel in the Pediatric Population


Sponsor

Texas Scottish Rite Hospital for Children

Enrollment

100 participants

Start Date

Dec 1, 2025

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 13 YearsMax Age: 21 Years

Inclusion Criteria3

  • 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 Criteria8

  • 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 to provide informed consent
  • Prior history of hypersensitivity to Exparel or any local anesthesia
  • BMI ≥ 40

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Interventions

DRUGExparel

Patients will be randomized to receive Exparel intraoperatively via local infiltration.


Locations(1)

Texas Scottish Rite Hospital for Children

Frisco, Texas, United States

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NCT06559215


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