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Pain, PostoperativeNCT02860091

Blood Ropivacaine Concentrations Following Chest Wall Nerve Block Continuous Infusion

An observational study of Pain, Postoperative, run by Boston Children's Hospital at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages Up to 4 years
Conditions the study is for
Pain, Postoperative
What is being tested?
Ropivacaine infusion
Type of treatment
Injection or infusion
How many people
26 participants
Where
1 siteUnited States
Study dates
1 Oct 2018to 14 May 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 4 years
  • All sexes
  • No healthy volunteers
  • Child

Study population: Patients undergoing surgical esophageal atresia repair and/or related procedures receiving continuous ropivacaine via paravertebral catheter or erector spine catheter.

Who may be able to join

  • 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

Who cannot join

  • Hepatic dysfunction
  • Local anesthetic allergy

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Boston Children"S Hospital

    Boston, Massachusetts, 02118

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Ropivacaine infusion
Keywords
ropivacaine infusion, regional anesthesia, paravertebral block
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ropivacaine infusionDrug

    Also called Naropin

    Delivered via paravertebral nerve block catheter.

Study groups in NCT02860091
Study groupRoleWhat they receive
Ropivacaine infusionPatients receiving continuous ropivacaine infusion for approximately 7 days via paravertebral nerve block or erector spinae catheter managed according to existing institutional protocols.
Receives: Drug: Ropivacaine infusion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Blood ropivacaine concentration

    Plasma ropivacaine concentration

    Measured: 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2016 (estimated)
  2. Study start1 Oct 2018
  3. Primary completion14 May 2026
  4. Study completion14 May 2026

Why it stopped: Sample processing no longer possible.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02860091
Sponsor's protocol ID
IRB-P00022295
Status last verified
May 2026
First submitted
3 Aug 2016
Last updated
18 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Pain, Postoperative, run by Boston Children's Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Sample processing no longer possible.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Blood ropivacaine concentration (time frame: 7 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.

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