Phase 4 N=4 Supportive Care

Ropivacaine Plasma Concentrations and Pharmacokinetics Following Erector Spinae Plane Block in the Pediatric Population

Anesthesia, Local

Bottom Line

View on ClinicalTrials.gov: NCT04298099 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2024

Primary outcome: Primary: Ropivacaine Concentrations — 0; 0; 1232.25; 850.25 ng/mL

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Ropivacaine (Drug)
Age: Pediatric, Adult · 0+ yrs
Sex: All
Sponsor: Baylor College of Medicine
Primary completion: Jan 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Ropivacaine Concentrations	0; 0; 1232.25; 850.25; 776.25; 518	—
SECONDARY Post-anesthesia Care Unit Pain Scores Using FLACC Scale	—	—
SECONDARY Post-anesthesia Care Unit Pain Scores Using FACES Pain Rating Scale	—	—
SECONDARY Post-anesthesia Care Unit Pain Scores Using VAS	5; 1.68; 6	—
SECONDARY Morphine Equivalents	5; 1.68; 0; 6	—

Summary

The primary aim of this study is to evaluate the pharmacokinetics of serum ropivacaine concentrations following erector spinae plane peripheral nerve blocks in the pediatric population. Secondary outcomes will assess the efficacy of the block with perioperative morphine equivalent consumption and pain scores.

Eligibility Criteria

Inclusion Criteria

Age: 6 months - 95% percentile

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04298099). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.