← Back to Search

Local Anesthetic

Exparel + Marcaine Group for Pain relief

Phase 2
Waitlist Available
Led By Philip Wilson, MD
Research Sponsored by Texas Scottish Rite Hospital for Children
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Patients 10+ years old
* Presenting with an injury that requires an isolated MPFL reconstruction
Timeline
Screening 3 weeks
Treatment Varies
Follow Up postoperative days 1, 4, and 7
Awards & highlights

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

Who is the study for?
This trial is for pediatric patients undergoing surgery to reconstruct the medial patellofemoral ligament (MPFL) due to kneecap dislocations or sports injuries. Participants should not have used any other pain management drugs that could affect the study's results.
What is being tested?
The trial tests if Exparel, when used with Marcaine during MPFL reconstruction surgery, provides better pain relief and reduces narcotic use compared to using Marcaine alone. Pain levels and narcotic consumption are monitored up to one week post-surgery.
What are the potential side effects?
Possible side effects of Exparel may include local reactions at the injection site, nausea, vomiting, constipation, itching, or fever. These are common side effects associated with medications used for pain management.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~postoperative days 1, 4, and 7
This trial's timeline: 3 weeks for screening, Varies for treatment, and postoperative days 1, 4, and 7 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Pain Management Patient Satisfaction questionnaire
Scottish Rite for Children-developed pain questionnaire
Visual Analog Scale (VAS) 10-centimeter line 0-10 Numeric Pain Intensity Scale
+1 more
Secondary study objectives
Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Scale v1.0 - Global Health 7+2

Trial Design

2Treatment groups
Active Control
Group I: Exparel + Marcaine GroupActive Control1 Intervention
* If \< 40 kg: 4 mg Exparel per kg BW and 30 mL 0.9% normal saline * If 40-70 kg: 10 mL Exparel, 10 mL 0.25% Marcaine, and 10 mL 0.9% normal saline * If \> 70 kg: 20 mL Exparel and 10 mL 0.25% Marcaine
Group II: Marcaine Only GroupActive Control1 Intervention
* If ≤ 20 kg: 1 mL/kg 0.25% Marcaine * If \> 20 - 70 kg: 20 mL 0.25% Marcaine and 10 mL 0.9% normal saline * If \> 70 kg: 30 mL 0.25% Marcaine and 20 mL 0.9% normal saline

Find a Location

Who is running the clinical trial?

Texas Scottish Rite Hospital for ChildrenLead Sponsor
20 Previous Clinical Trials
8,998 Total Patients Enrolled
Philip Wilson, MDPrincipal InvestigatorTexas Scottish Rite Hospital for Children
1 Previous Clinical Trials
160 Total Patients Enrolled
~67 spots leftby Dec 2026