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

Part of paid clinical trials in Frisco, Texas.

Sponsor
Texas Scottish Rite Hospital for Children
Study ID
NCT06559215
Phase
PHASE2
Status
Recruiting
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Conditions

  • Analgesia
  • Medial Patellofemoral Ligament (MPFL) Reconstruction
  • Pain, Postoperative
  • Sports Injuries in Children

Eligibility Criteria

Sex
ALL
Age
13 Years - 21 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

Start date
Dec 1, 2025
Status verified
Mar 2026
Primary completion
Sep 30, 2027
Completion
Sep 30, 2028

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Exparel + Marcaine Group
    Local Infiltration: Regardless of weight: 10 mL Exparel and 10 mL 0.25% Marcaine
  • No Intervention: Marcaine Only Group
    Local Infiltration: Regardless of weight: 20 mL 0.25% Marcaine

Primary Outcome Measure

Visual Analog Scale (VAS) Wong-Baker Face Pain Scale [ Time Frame: Postoperative days 1, 4, and 7 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Texas Scottish Rite Hospital for ChildrenFriscoTexas75034
Robert Van Pelt, MPH
[email protected]
214-559-7456
Anna Wilhelmy, MS
[email protected]
469-857-2109
Philip Wilson, MD (PRINCIPAL_INVESTIGATOR)
Henry Ellis, MD (SUB_INVESTIGATOR)
John Arvesen, MD (SUB_INVESTIGATOR)
Cody Todesco, PA (SUB_INVESTIGATOR)
Benjamin Johnson, PA (SUB_INVESTIGATOR)
Charles Wyatt, CPNP (SUB_INVESTIGATOR)
Stephanie Stutz, MS (SUB_INVESTIGATOR)

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Texas Scottish Rite Hospital for Children· Frisco, TX

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