Blood Ropivacaine Concentrations Following Chest Wall Nerve Block Continuous Infusion

NCT02860091 | Active Not Recruiting DMC FDA Drug

• 1 other identifier: IRB-P00022295
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative

Keywords

ropivacaine infusion; regional anesthesia; paravertebral block

Outcome Measures

Primary Outcomes (1)

• Blood ropivacaine concentration

  Plasma ropivacaine concentration

  7 days

Study Arms (1)

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

Interventions

Ropivacaine infusion DRUG

Delivered via paravertebral nerve block catheter.

Also known as: Naropin

Ropivacaine infusion

Eligibility Criteria

• Age: Up to 4 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Hepatic dysfunction
• Local anesthetic allergy

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children"S Hospital

Boston, Massachusetts, 02118, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Post-analysis specimens will be frozen and retained for further analysis, if necessary.

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• ROLAND BRUSSEAU

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor

Study Record Dates

• First Submitted: August 3, 2016
• First Posted: August 9, 2016
• Study Start: October 1, 2018
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: September 26, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)