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

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ClinicalTrials.gov Identifier: NCT04298099
Recruitment Status : Not yet recruiting
First Posted : March 6, 2020
Last Update Posted : March 6, 2020
Sponsor:
Information provided by (Responsible Party):
Karla Elizabeth Wyatt, Baylor College of Medicine

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
Anesthesia, Local Drug: Ropivacaine 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 at 10, 20, 30, 45, 60, 90-minutes and 2, 4, 6 and 12-hours from intravenous access in situ. 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).

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Study Type : Interventional  (Clinical Trial)
Estimated 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 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
Estimated Study Start Date : April 1, 2020
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Ropivacaine Concentrations [ Time Frame: 10, 20, 30, 45, 60, 90-minutes and 2, 4, 6 and 12-hours from 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 [ 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.

  2. 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.

  3. 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.

  4. Morphine Equivalents [ Time Frame: 12 hours ]
    Consumption of morphine post operatively



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Ages Eligible for Study:   6 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04298099


Contacts
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Contact: Karla Wyatt, MD, MS 832-824-5800 kewyatt@bcm.edu
Contact: Margaret Owens-Stuberfield, RN 832-824-5800 owensstu@bcm.edu

Locations
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United States, Texas
Texas Children's Hospital
Houston, Texas, United States, 77030
Contact: Karla Wyatt, MD    832-824-5800    karla.wyatt@bcm.edu   
Sponsors and Collaborators
Baylor College of Medicine
Investigators
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Principal Investigator: Karla Wyatt, MD, MS Baylor College of Medicine
Publications:
Walker BJ, Long JB, Sathyamoorthy M, Birstler J, Wolf C, Bosenberg AT, Flack SH, Krane EJ, Sethna NF, Suresh S, Taenzer AH, Polaner DM, Martin L, Anderson C, Sunder R, Adams T, Martin L, Pankovich M, Sawardekar A, Birmingham P, Marcelino R, Ramarmurthi RJ, Szmuk P, Ungar GK, Lozano S, Boretsky K, Jain R, Matuszczak M, Petersen TR, Dillow J, Power R, Nguyen K, Lee BH, Chan L, Pineda J, Hutchins J, Mendoza K, Spisak K, Shah A, DelPizzo K, Dong N, Yalamanchili V, Venable C, Williams CA, Chaudahari R, Ohkawa S, Usljebrka H, Bhalla T, Vanzillotta PP, Apiliogullari S, Franklin AD, Ando A, Pestieau SR, Wright C, Rosenbloom J, Anderson T; Pediatric Regional Anesthesia Network Investigators. Complications in Pediatric Regional Anesthesia: An Analysis of More than 100,000 Blocks from the Pediatric Regional Anesthesia Network. Anesthesiology. 2018 Oct;129(4):721-732. doi: 10.1097/ALN.0000000000002372.

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Responsible Party: Karla Elizabeth Wyatt, Assistant Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT04298099    
Other Study ID Numbers: H-46638
First Posted: March 6, 2020    Key Record Dates
Last Update Posted: March 6, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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, Baylor College of Medicine:
Ropivacaine
Erector spinae plane block
Pediatric
Additional relevant MeSH terms:
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Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents