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

Sponsor
Baylor College of Medicine (Other)
Overall Status
Recruiting
CT.gov ID
NCT04298099
Collaborator
(none)
24
Enrollment
1
Location
2
Arms
26.4
Anticipated Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
24 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
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 basisParticipants 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
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Ropivacaine Plasma Concentrations and Pharmacokinetics Following Erector Spinae Plane Block in the Pediatric Population
Actual Study Start Date :
Dec 17, 2020
Anticipated Primary Completion Date :
Nov 1, 2022
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Ropivacaine 0.2% at 0.3ml/kg

Ropivacaine 0.2% at 0.3ml/kg

Drug: Ropivacaine
Given the reproducible efficacy of the erector spinae plane block for thoracic procedures, this pilot study will recruit patients scheduled to undergo thoracic surgery with the adjunct of an erector spinae plane block for perioperative pain. Participants will be assigned sequentially to either ropivacaine 0.2% at 0.3ml/kg or ropivacaine 0.5% at 0.3ml/kg.
Active Comparator: Ropivacaine 0.5% at 0.3ml/kg

Ropivacaine 0.5% at 0.3ml/kg

Drug: Ropivacaine
Given the reproducible efficacy of the erector spinae plane block for thoracic procedures, this pilot study will recruit patients scheduled to undergo thoracic surgery with the adjunct of an erector spinae plane block for perioperative pain. Participants will be assigned sequentially to either ropivacaine 0.2% at 0.3ml/kg or ropivacaine 0.5% at 0.3ml/kg.

Outcome Measures

Primary Outcome Measures

  1. Ropivacaine Concentrations [Prior to administration and at 30, 60, 90-minutes and 2, 4, 6-hours following intravenous access in situ]

    Pharmacokinetics of free and total serum ropivacaine concentrations following erector spinae plane peripheral nerve block

Secondary Outcome Measures

  1. Post-anesthesia Care Unit Pain Scores using FLACC Scale [Every 4 hours (up to 12 hours after arrival in PACU)]

    The Face, Legs, Activity, Cry, Consolability Scale (FLACC) is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2. Scores will be tracked from nursing inputs.

  2. Post-anesthesia Care Unit Pain Scores using FACES Pain Rating Scale [Every 4 hours (up to 12 hours after arrival in PACU)]

    The FACES Pain Rating Scale is a tool originally created for children to help them communicate their pain. Now the scale is used around the world with people ages 3 and older. The scale uses 6 faces scored 0-10 with 0 representing no pain. Each facial criteria increases by a score of 2. Scores will be tracked from nursing inputs.

  3. Post-anesthesia Care Unit Pain Scores using VAS [Every 4 hours (up to 12 hours after arrival in PACU)]

    The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." A score of 0 represents no pain. Scores will be tracked from nursing inputs.

  4. Morphine Equivalents [12 hours]

    Consumption of morphine post operatively

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Months to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Texas Children's Hospital Houston Texas United States 77030

Sponsors and Collaborators

  • Baylor College of Medicine

Investigators

  • Principal Investigator: Karla Wyatt, MD, MS, Baylor College of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Karla Elizabeth Wyatt, Assistant Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT04298099
Other Study ID Numbers:
  • H-46638
First Posted:
Mar 6, 2020
Last Update Posted:
Mar 2, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Karla Elizabeth Wyatt, Assistant Professor, Baylor College of Medicine
Ropivacaine
Erector spinae plane block
Pediatric
Additional relevant MeSH terms:
Ropivacaine

Study Results

No Results Posted as of Mar 2, 2022