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Local Anesthetic

Exparel for Postoperative Pain

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

Be younger than 65 years old

Must not have

Patients <10 years old

Any MPFL Reconstruction that requires the use of arthrotomy or a tibial tubercle osteotomy (TTO)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up preoperatively and within one week postoperatively

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if using Exparel during knee surgery in children can help reduce pain and the need for painkillers after the operation. They will compare patients who receive Exparel and

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

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I am over 10 years old and need surgery for a specific knee injury.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am under 10 years old.

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I need or had a specific knee ligament surgery involving bone work.

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I need surgery for a leg injury that isn't just an MPFL repair.

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I need surgery for a fracture or another specific injury.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ postoperative days 1, 4, and 7

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 5Eligibility criteria met