Clinical trial NCT06559215: Evaluation of Pain Management After Surgery When Using Exparel in the Pediatric Population
Official title: Prospective Evaluation of Post-operative Pain Management Using Exparel in the Pediatric Population
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
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
Lead sponsor: Texas Scottish Rite Hospital for Children
Sponsor class: OTHER
First posted: 2024-08-19
Enrollment: 100
Sex: ALL
Minimum age (years): 12
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: This is a single institution, prospective, single-blinded (participant) randomized controlled trial to investigate the pain-control efficacy and patient reported pain outcomes of Exparel use in youth receiving medial patellofemoral ligament (MPFL) Reconstruction. Participants will be approached pre-operatively for participation, after which the surgical team will be informed. Participants will be offered the choice to participate in the study and randomize their treatment group. If participants do not want their treatment to be randomized, they will not be included in the study.

Participants enrolled in this study will receive either Exparel + Marcaine intraoperatively or Marcaine only intraoperatively during their MPFL reconstruction surgery. At post-operative days 1, 4 and 7, participants will receive and complete questionnaires regarding their pain scores, levels, and outcomes, effective pain treatments, overall pain interference, narcotic use (number of pills taken), and overall pain treatment satisfaction. Additionally, participants may receive and complete secondary outcome measures of functional and psychological outcomes regarding their MPFL reconstruction surgery.

As per the institutional pain management protocol, participants will receive the following anesthesia doses by body weight (BW):

Pre-operatively:

* Regardless of age: 0.5 mg midazolam per kg BW (intravenous, 15 mg maximum)
* If patient has history of post-operative nausea or vomiting (PONV), 0.40 mg Emend per kg BW (pill), and 2 mg midazolam (intravenous)

Intra-operatively:

* 0.5-1.0 mg Lidocaine per kg BW (intravenous, 80 mg maximum)
* 3-4 mg Propofol per kg BW
* 1-2 mcg Fentanyl per kg BW (maximum 100 mcg)
* 0.35 mg Ketamine per kg BW (single dose or titration)
* 0.1 mg Dexamethasone per kg BW (maximum 10 mg)

Optional:

* 10-20 mcg Dexmedetomidine per kg BW (for persistent tachycardia)
* If intubated/ventilated: 0.5-0.6 mg Rocuronium per kg BW, \~2 mg/kg sugammadex for reversal
* If Tranexamic Acid administered: 15 mg per kg BW (10-15 min intravenous, maximum 1 g)
* For maintenance: 1 Minimum Alveolar Concentration (MAC) Sevoflurane and 15 mg Acetaminophen per kg BW (maximum 1 g)
* If necessary during emergence: 0.004-0.005 mg hydromorphone per kg BW, 0.5 mg Ketorolac per kg BW (maximum 30 mg), and 0.1 mg Ondansetron per kg BW (maximum 4 mg)
* If post-anesthesia care unit (PACU) (Phase 1) medication required: 0.004-0.006 mg hydromorphone per kg BW and 0.10-0.15 mg Oxycodone per kg BW
* If PACU (Phase 2) medication required: Metoclopramide, Dexamethasone, Promethazine, or Ondansetron

Exparel + Marcaine Group:

* Local Infiltration:
* 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

Marcaine Only Group:

* Local Infiltration:
* 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

Post-Operatively:

* If ≤ 12 years:
* Alternate weight-adjusted Acetaminophen and Ibuprofen every 3 hours
* Rescue: Weight-adjusted Acetaminophen/Hydrocodone substituted for Acetaminophen for severe pain (every 6 hours, maximum 8 doses)
* If \> 12 years:
* Days 1-3: Alternate weight-adjusted Acetaminophen and 10 mg Ketorolac every 3 hours
* Days 4-7: Alternate weight-adjusted Acetaminophen and Ibuprofen every 3 hours
* Days 1-5: 40 mg Famotidine every 12 hours
* Rescue: Weight-adjusted Tramadol taken with Acetaminophen for severe pain (every 6 hours, maximum 8 doses)

The investigators will enroll 50 participants in each treatment group with 40 in each group needed for a sufficiently powered analysis.

Eligibility criteria: Inclusion Criteria:

* Must be aged 12+ 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 \<12 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

Primary outcomes:
measure: Visual Analog Scale (VAS) Wong-Baker Face Pain Scale
timeFrame: Postoperative days 1, 4, and 7
measure: Visual Analog Scale (VAS) 10-centimeter line 0-10 Numeric Pain Intensity Scale
timeFrame: Postoperative days 1, 4, and 7
measure: Scottish Rite for Children-developed pain questionnaire
timeFrame: Postoperative days 1, 4, and 7
measure: Pain Management Patient Satisfaction questionnaire
timeFrame: Postoperative day 7
Secondary outcomes:
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Scale v1.0 - Global Health 7+2
timeFrame: Preoperatively and within one week postoperatively
Other outcomes:
Locations:
city: Frisco
country: United States
facility: Texas Scottish Rite Hospital for Children
state: Texas
Study officials:
affiliation: Texas Scottish Rite Hospital for Children
name: Philip Wilson, MD
role: PRINCIPAL_INVESTIGATOR
References: