Status:
NOT_YET_RECRUITING
Evaluation of Pain Management After Surgery When Using Exparel in the Pediatric Population
Lead Sponsor:
Texas Scottish Rite Hospital for Children
Conditions:
Medial Patellofemoral Ligament (MPFL) Reconstruction
Sports Injuries in Children
Eligibility:
All Genders
13-21 years
Phase:
PHASE2
Brief 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 orthopae...
Detailed 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 rece...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2028
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06559215
Start Date
September 1 2025
End Date
September 1 2028
Last Update
September 22 2025
Active Locations (1)
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1
Texas Scottish Rite Hospital for Children
Frisco, Texas, United States, 75034