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

February 28, 2022 updated by: Karla Elizabeth Wyatt, Baylor College of Medicine

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Karla Wyatt, MD, MS
  • Phone Number: 832-824-5800
  • Email: kewyatt@bcm.edu

Study Contact Backup

  • Name: Margaret Owens-Stuberfield, RN
  • Phone Number: 832-824-5800
  • Email: owensstu@bcm.edu

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Texas Children's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ropivacaine Concentrations
Time Frame: 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
Prior to administration and at 30, 60, 90-minutes and 2, 4, 6-hours following intravenous access in situ

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-anesthesia Care Unit Pain Scores using FLACC Scale
Time Frame: 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.
Every 4 hours (up to 12 hours after arrival in PACU)
Post-anesthesia Care Unit Pain Scores using FACES Pain Rating Scale
Time Frame: 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.
Every 4 hours (up to 12 hours after arrival in PACU)
Post-anesthesia Care Unit Pain Scores using VAS
Time Frame: 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.
Every 4 hours (up to 12 hours after arrival in PACU)
Morphine Equivalents
Time Frame: 12 hours
Consumption of morphine post operatively
12 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baylor College of Medicine

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 17, 2020

Primary Completion (Anticipated)

November 1, 2022

Study Completion (Anticipated)

March 1, 2023

Study Registration Dates

First Submitted

March 3, 2020

First Submitted That Met QC Criteria

March 4, 2020

First Posted (Actual)

March 6, 2020

Study Record Updates

Last Update Posted (Actual)

March 2, 2022

Last Update Submitted That Met QC Criteria

February 28, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-46638

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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