Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT02860091 |
| Other study ID # |
IRB-P00022295 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2018 |
| Est. completion date |
December 2024 |
Study information
| Verified date |
November 2023 |
| Source |
Boston Children's Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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 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.
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.
