Recruiting
Phase 2

Exparel & Marcaine

Sponsor:

Texas Scottish Rite Hospital for Children

Code:

NCT06559215

Conditions

Medial Patellofemoral Ligament (MPFL) Reconstruction

Sports Injuries in Children

Analgesia

Pain, Postoperative

Eligibility Criteria

Sex: All

Age: 13 - 21

Healthy Volunteers: Not accepted

Interventions

Exparel

Study Details

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 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

Conditions

Medial Patellofemoral Ligament (MPFL) Reconstruction

Sports Injuries in Children

Analgesia

Pain, Postoperative

Study ID

NCT06559215

Start date

Dec 1, 2025

Status verified date

Mar, 2026

Completion date

Sep, 2028

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13 - 21

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Exparel

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

Primary outcome measure

  • Visual Analog Scale (VAS) Wong-Baker Face Pain Scale [ Time Frame: Postoperative days 1, 4, and 7 ]
  • Visual Analog Scale (VAS) 10-centimeter line 0-10 Numeric Pain Intensity Scale [ Time Frame: Postoperative days 1, 4, and 7 ]
  • Scottish Rite for Children-developed pain questionnaire [ Time Frame: Postoperative days 1, 4, and 7 ]
  • Pain Management Patient Satisfaction questionnaire [ Time Frame: Postoperative day 7 ]

Central Contacts and Locations

Central contacts

Robert Van Pelt, MPH

2145597456bobby.vanpelt@tsrh.org

Anna Wilhelmy, MS

469-857-2109anna.wilhelmy@tsrh.org

Locations

Texas Scottish Rite Hospital for Children

Recruiting

Frisco, Texas, United States, 75034

Contacts

Robert Van Pelt, MPH

214-559-7456bobby.vanpelt@tsrh.org

Anna Wilhelmy, MS

469-857-2109anna.wilhelmy@tsrh.org

Principal Investigator:

Philip Wilson, MD

More Information

Sponsor

Texas Scottish Rite Hospital for Children

Last update posted

Mar 9, 2026

Last verified

Mar, 2026

Keywords

  • Narcotic use
  • Postoperative pain management
  • MPFL reconstruction
  • Visual Analog Scale (VAS) pain scores
  • Multimodal pain management protocol

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Texas Scottish Rite Hospital for Children on 2026-03-09.