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Blood Ropivacaine Concentrations Following Unilateral Chest Wall Nerve Block and Continuous Infusion in Infants and Toddlers Undergoing Thoracotomies

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ClinicalTrials.gov Identifier: NCT02860091
Recruitment Status : Recruiting
First Posted : August 9, 2016
Last Update Posted : October 14, 2020
Sponsor:
Information provided by (Responsible Party):
Roland Brusseau, Boston Children's Hospital

Brief Summary:

The main objective of this proposed investigation is to evaluate blood ropivacaine concentrations in infants and toddlers following the initiation of, and over the course of, continuous paravertebral nerve blockade using ropivacaine infusion for postoperative pain control following esophageal atresia repair procedures that include posterior tracheopexy.

Continuous unilateral chest wall nerve blockade (CUCWNB) using ropivacaine is the current standard of practice for this surgical population at the investigators' institution and, as such, this study does not aim to alter the current standard clinical care received by participants but rather evaluate the blood concentrations of ropivacaine as it is routinely used.


Condition or disease Intervention/treatment
Pain, Postoperative Drug: Ropivacaine infusion

Detailed Description:

Post-surgical pain management is often suboptimal in pediatric patients, especially in those with complex past medical and past surgical histories. Physicians generally, and physicians at Boston Children's Hospital (BCH), in particular, are employing regional anesthetic techniques as either primary or adjunct measures for perioperative pain control. One of the benefits of regional anesthesia is the avoidance, or at least limitation of, opioid and benzodiazepine exposure.

CUCWNB is a regional anesthesia technique that uses an indwelling catheter, placed under ultrasound guidance, which terminates in the paravertebral space for a paravertebral nerve block or at the base of the erector spinae muscle complex immediately lateral to the paravertebral space for an erector spinae nerve block. Introduction of local anesthetic through this catheter produces ipsilateral somatic and sympathetic nerve blockade in multiple contiguous dermatomes. The technique provides effective analgesia for unilateral thoracic and abdominal surgical procedures.

CUCWNB using ropivacaine is used regularly at this institution for patients of all ages as a part of various multimodal intra- and post-operative pain management strategies. The success of CUCWNB implementation for infants and toddlers undergoing thoracotomies has been so marked that this technique has become essentially a de facto standard of care for this population at BCH.

Unfortunately, even as of today, studies demonstrating the pharmacokinetic profile of ropivacaine CUCWNB in infants and toddlers are not available. A few studies have examined plasma levels of ropivacaine after single injection paravertebral nerve blocks in adult patients. For example, a single bolus injection of 2mg/kg was well tolerated, not exceeding peak plasma concentrations of 2.5 µg/ml, well below the concentration considered a threshold for ropivacaine local anesthetic systemic toxicity (LAST). However, it is unclear how applicable this data is to our complex pediatric surgical patients at BCH.

In order to more fully understand plasma ropivacaine concentrations during CUCWNB, and particularly how these concentrations relate to known thresholds for ropivacaine-induced systemic local anesthetic toxicity, the investigators plan to measure plasma concentrations of ropivacaine at various time points following initiation of CUCWNB in infant and toddler patients having just undergone esophageal atresia repair with posterior tracheopexy.

This study does not aim to alter the current standard clinical care received by participants. No additional treatments will be provided as part of the study. Continuous ropivacaine infusion via paravertebral nerve block catheter, the standard practice for this surgical population at the investigators' institution, will be administered to enrolled (and non-enrolled) patients undergoing esophageal atresia repair with posterior tracheopexy. Paravertebral ropivacaine infusion is directed by BCH Pain Treatment Service, using existing dosage and management protocols.

The investigators' goal is to better understand plasma ropivacaine levels during continuous infusion and how they relate to currently understood thresholds for induced systemic local anesthetic toxicity in infants and toddlers, so as to develop evidence-based safety guidelines for ropivacaine infusion in infants and toddlers undergoing CUCWNB.

The investigators expect to describe the pharmacokinetics of ropivacaine via CUCWNB for postoperative pain management of infants and toddlers following thoracotomies. Knowledge of the systemic absorption of ropivacaine delivered by CUCWNB may provide new insights into appropriate dosing in order to prevent LAST. This is of particular interest in the subgroup of infants for whom rates of metabolism and elimination of local anesthetic drugs are poorly understood.

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Blood Ropivacaine Concentrations Following Unilateral Chest Wall Nerve Block and Continuous Infusion in Infants and Toddlers Undergoing Thoracotomies
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Ropivacaine infusion
Patients receiving continuous ropivacaine infusion for approximately 7 days via paravertebral nerve block or erector spinae catheter managed according to existing institutional protocols.
Drug: Ropivacaine infusion
Delivered via paravertebral nerve block catheter.
Other Name: Naropin




Primary Outcome Measures :
  1. Blood ropivacaine concentration [ Time Frame: 7 days ]
    Plasma ropivacaine concentration


Biospecimen Retention:   Samples Without DNA
Post-analysis specimens will be frozen and retained for further analysis, if necessary.


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 4 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing surgical esophageal atresia repair and/or related procedures receiving continuous ropivacaine via paravertebral catheter or erector spine catheter.
Criteria

Inclusion Criteria:

  • Infants and toddlers (0-4) years
  • Undergoing a procedure that requires a thoracotomy for esophageal atresia repair and related procedures
  • Receiving ropivacaine via continuous paravertebral nerve block catheter or erector spinae catheter

Exclusion Criteria:

  • Hepatic dysfunction
  • Local anesthetic allergy

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): NCT02860091


Contacts
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Contact: ROLAND BRUSSEAU, MD 617-947-1434 ROLAND.BRUSSEAU@CHILDRENS.HARVARD.EDU

Locations
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United States, Massachusetts
Boston Children"S Hospital Recruiting
Boston, Massachusetts, United States, 02118
Contact: ROLAND BRUSSEAU, MD    857-218-4814    roland.brusseau@childrens.harvard.du   
Contact: WALID ALRAYASHI, MD    617-355-2604    walid.alrayashi@childrens.harvard.edu   
Sponsors and Collaborators
Boston Children's Hospital
Investigators
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Principal Investigator: ROLAND BRUSSEAU Boston Children's Hospital
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Responsible Party: Roland Brusseau, Instructor, Boston Children's Hospital
ClinicalTrials.gov Identifier: NCT02860091    
Other Study ID Numbers: IRB-P00022295
First Posted: August 9, 2016    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Roland Brusseau, Boston Children's Hospital:
ropivacaine infusion
regional anesthesia
paravertebral block
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents