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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age13-21
SponsorTexas Scottish Rite Hospital for Children

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Exparel

    Drug

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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Exparel + Marcaine GroupActive comparator 1 intervention
Group B: Marcaine Only GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
Postoperative days 1, 4, and 7
2

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

Time frame
Postoperative days 1, 4, and 7
3

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.

Time frame
Postoperative days 1, 4, and 7
4

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.

Time frame
Postoperative day 7

Secondary outcomes

1

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

Questionnaire of outcomes regarding their overall health (scored 20-80, 20 = poor and 80 = good).

Time frame
Preoperatively and within one week postoperatively

Other outcomes

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