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NCT06559215 · ClinicalTrials.gov registry record · Phase 2
Evaluation of Pain Management After Surgery When Using Exparel in the Pediatric Population
A Phase 2 study of Pain, Postoperative and Analgesia, sponsored by Texas Scottish Rite Hospital for Children.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT06559215 is a Phase 2 study of Pain, Postoperative and Analgesia that is actively recruiting participants, run by Texas Scottish Rite Hospital for Children. The registered enrollment target is 100 participants, below the 272-participant average among 108 other Pain, Postoperative trials with a reported enrollment target (63% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06559215, a Phase 2 study of Pain, Postoperative and Analgesia, is actively recruiting participants, sponsored by Texas Scottish Rite Hospital for Children.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- DRUG Exparel
Study Locations (1)
Texas
- Texas Scottish Rite Hospital for Children - Frisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2025-12-01 |
| Est. Completion | 2028-09 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06559215
The ClinicalTrials.gov registry entry for NCT06559215 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 272-participant average among 108 other Pain, Postoperative trials with a reported enrollment target (63% lower). The listed sponsor is Texas Scottish Rite Hospital for Children, which has 15 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Pain, Postoperative appearing as the primary indexed condition, and to 1 intervention - of which Exparel is the first listed.
NCT06559215 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT06559215 about?
NCT06559215 is a clinical study titled "Evaluation of Pain Management After Surgery When Using Exparel in the Pediatric Population". 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 q...
What is the current status of trial NCT06559215?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2025-12-01. Estimated completion is 2028-09.
What conditions does trial NCT06559215 study?
This clinical trial studies the following conditions: Pain, Postoperative, Analgesia, Medial Patellofemoral Ligament (MPFL) Reconstruction, Sports Injuries in Children.
What interventions are being tested in trial NCT06559215?
The interventions under investigation include: Exparel (DRUG).
Who is sponsoring clinical trial NCT06559215?
This trial is sponsored by Texas Scottish Rite Hospital for Children, which has 15 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06559215 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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