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

NCT06559215 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: STU-2024-0773
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Visual Analog Scale (VAS) Wong-Baker Face Pain Scale

  Scale with evocative faces from 0-10 (0 = No Pain, 10 = Worst Pain Possible) that assists children in communicating about their pain

  Postoperative days 1, 4, and 7

• Visual Analog Scale (VAS) 10-centimeter line 0-10 Numeric Pain Intensity Scale

  Sliding scale from 0-10 (0 = No Pain, 10 = Pain as bad as it could possibly be) that enables a more accurate estimate of pain score

  Postoperative days 1, 4, and 7

• Scottish Rite for Children-developed pain questionnaire

  Institutional questionnaire that asks how many narcotic pills the patient has taken (0 - 12 pills), if their pain is controlled, treatments that lessens their pain, term that best describes their pain, how much their pain has interfered with daily tasks and overall mood, and sleep interference due to pain.

  Postoperative days 1, 4, and 7

• Pain Management Patient Satisfaction questionnaire

  Questionnaire that asks how satisfied patients are with their pain treatment (0 = Not Satisfied, 10 = Extremely Satisfied), if they contacted their physician due to ineffective pain treatment, how helpful the information provided for pain treatment was (0 = Not Helpful, 10 = Extremely Helpful), and a free response section to explain why they were not satisfied with their pain treatment and if they have any additional comments or suggestions based on their pain treatment.

  Postoperative day 7

Secondary Outcomes (1)

• Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Scale v1.0 - Global Health 7+2

  Preoperatively and within one week postoperatively

Study Arms (2)

Exparel + Marcaine Group

ACTIVE COMPARATOR

Local Infiltration: Regardless of weight: 10 mL Exparel and 10 mL 0.25% Marcaine

Drug: Exparel

Marcaine Only Group

NO INTERVENTION

Local Infiltration: Regardless of weight: 20 mL 0.25% Marcaine

Interventions

Exparel DRUG

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

Also known as: Liposomal bupivacaine

Exparel + Marcaine Group

Eligibility Criteria

• Age: 13 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Texas Scottish Rite Hospital for Children: lead

Study Sites (1)

Texas Scottish Rite Hospital for Children

Frisco, Texas, 75034, United States

RECRUITING

MeSH Terms

Conditions

Agnosia; Pain, Postoperative

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain

Study Officials

• Philip Wilson, MD

  Texas Scottish Rite Hospital for Children

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert Van Pelt, MPH

CONTACT

2145597456; bobby.vanpelt@tsrh.org

Anna Wilhelmy, MS

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients will be randomized after consent is obtained and will not know if they receive Exparel intraoperatively.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2024
• First Posted: August 19, 2024
• Study Start: December 1, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: March 9, 2026

Record last verified: 2026-03

Locations

US (1)