Blood Ropivacaine Concentrations Following Nerve Block in Infants and Toddlers Undergoing Esophageal Atresia Repair
| Status: | Recruiting |
|---|---|
| Conditions: | Post-Surgical Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | Any - 4 |
| Updated: | 10/4/2018 |
| Start Date: | October 1, 2018 |
| End Date: | December 2020 |
| Contact: | ROLAND BRUSSEAU, MD |
| Email: | ROLAND.BRUSSEAU@CHILDRENS.HARVARD.EDU |
| Phone: | 617-947-1434 |
Blood Ropivacaine Concentrations Following Paravertebral Nerve Block and Continuous Infusion in Infants and Toddlers Undergoing Staged Esophageal Atresia Repair
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 paravertebral infusion of 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.
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 paravertebral infusion of 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.
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.
Continuous paravertebral nerve blockade (CPVNB) is a regional anesthesia technique that uses
an indwelling catheter, placed under ultrasound guidance, which terminates in the
paravertebral space. 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.
CPVNB 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 CPVNB implementation for infants and toddlers undergoing esophageal atresia 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 CPVNB 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 CPVNB, 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 CPVNB 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 CPVNB.
The investigators expect to describe the pharmacokinetics of ropivacaine via CPVNB for
postoperative pain management of infants and toddlers following esophageal atresia repairs.
Knowledge of the systemic absorption of ropivacaine delivered by CPVNB 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.
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.
Continuous paravertebral nerve blockade (CPVNB) is a regional anesthesia technique that uses
an indwelling catheter, placed under ultrasound guidance, which terminates in the
paravertebral space. 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.
CPVNB 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 CPVNB implementation for infants and toddlers undergoing esophageal atresia 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 CPVNB 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 CPVNB, 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 CPVNB 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 CPVNB.
The investigators expect to describe the pharmacokinetics of ropivacaine via CPVNB for
postoperative pain management of infants and toddlers following esophageal atresia repairs.
Knowledge of the systemic absorption of ropivacaine delivered by CPVNB 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.
Inclusion Criteria:
- Infants and toddlers (0-4) years
- Undergoing s esophageal atresia repair with posterior tracheopexy
- Receiving ropivacaine via continuous paravertebral nerve block catheter
Exclusion Criteria:
- Hepatic dysfunction
- Local anesthetic allergy
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