Clinical trial NCT04298099: Ropivacaine Plasma Concentrations and Pharmacokinetics Following Erector Spinae Plane Block in the Pediatric Population
Official title: Ropivacaine Plasma Concentrations and Pharmacokinetics Following Erector Spinae Plane Block in the Pediatric Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anesthesia, Local
Keywords: Ropivacaine
Erector spinae plane block
Pediatric
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2020-03-06
Enrollment: 4
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be assigned to either ropivacaine 0.2% at 0.3ml/kg or ropivacaine 0.5% at 0.3ml/kg on an odd/even basis
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: This pilot study will enroll patients at Texas Children's Hospital, aged 6 months to \<18 years scheduled to undergo a clinically indicated thoracic surgery with the adjunct of an erector spinae plane block for perioperative pain. A single shot erector spinae plane block is commonly offered for unilateral video-assisted thoracoscopic surgery (VATS) and unilateral chest tube insertions. Following parental consent and child assent to the block, participants will be assigned sequentially to either ropivacaine 0.2% at 0.3ml/kg or ropivacaine 0.5% at 0.3ml/kg. This pilot study poses no additional risk to the patient and the thoracic surgical procedures outlined are those for which an erector spinae plane block would be offered. Furthermore, the block dosing of 0.3ml/kg volumes with ropivacaine 0.2% or 0.5% are not outside of the standard of care or accepted dosages for peripheral nerve blocks.

Venous sample serum ropivacaine levels will be collected prior to ESP block and at 30, 60, 90-minutes and 2, 4, 6 -hours from intravenous access in situ. A baseline alpha-1 acid glycoprotein (AGP) test will be collected and processed by TCH Pathology. Amide local anesthetics are predominantly protein bound to AGP. It is the unbound form that is active. While this study seeks to understand the pharmacokinetics of ropivacaine following a single shot erector spinae plane block, correlate of the AGP will simultaneously ascertain the free vs bound portion.

Samples will be analyzed for the total and free serum ropivacaine concentrations. Pain scores will be collected from nursing records starting from arrival in the Post-Anesthesia Care Unit every 4 hours (up to 12 hours after arrival in PACU). Pain will be measured using The Face, Legs, Activity, Cry, Consolability scale (FLACC), the Wong-Baker FACES Pain Rating Scale (FACES), and the Visual Analogue Scale (VAS).

Eligibility criteria: Inclusion Criteria:

* Age: 6 months - \< 18 years old;
* Chest tubes or minimally invasive video assisted thoracic surgery;
* Surgery scheduled between 7AM and 5PM
* Weight greater than 4kg

Exclusion Criteria:

* Renal dysfunction;
* Liver dysfunction;
* Hypoalbuminemia;
* Allergy to local anesthetic;
* Spinal hardware or instrumentation;
* Scoliosis;
* Obesity defined as a BMI \>95% percentile

Primary outcomes:
measure: Ropivacaine Concentrations
timeFrame: Prior to administration and at 30, 60, 90-minutes and 2, 4, 6-hours following intravenous access in situ
Secondary outcomes:
measure: Post-anesthesia Care Unit Pain Scores Using FLACC Scale
timeFrame: Every 4 hours (up to 12 hours after arrival in PACU)
measure: Post-anesthesia Care Unit Pain Scores Using FACES Pain Rating Scale
timeFrame: Every 4 hours (up to 12 hours after arrival in PACU)
measure: Post-anesthesia Care Unit Pain Scores Using VAS
timeFrame: Every 4 hours (up to 12 hours after arrival in PACU)
measure: Morphine Equivalents
timeFrame: 12 hours
Other outcomes:
measure: Serum Alpha Acid Glycoprotein(AAG) Level
timeFrame: Pre-op
Locations:
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Karla Wyatt, MD, MS
role: PRINCIPAL_INVESTIGATOR
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