Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04567407 |
Other study ID # |
IRB-P00034302 |
Secondary ID |
|
Status |
Completed |
Phase |
Phase 4
|
First received |
|
Last updated |
|
Start date |
September 22, 2020 |
Est. completion date |
January 22, 2022 |
Study information
Verified date |
September 2023 |
Source |
Boston Children's Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
To evaluate the efficacy of bilateral continuous erector spinae blocks (BESB) for
postoperative analgesia in children and adolescents undergoing cardiac surgical procedures
via sternotomy in the Early Recovery After Surgery (ERAS) program in a single arm, open
label, interventional study.
Description:
Regional anesthesia-and pediatric regional anesthesia in particular-is a rapidly evolving
subfield of anesthesia practice driven with considerable urgency by the growing recognition
that even appropriate perioperative opioid administration can have significant deleterious
long-term effects.
Regional anesthetics can provide targeted, continuous analgesia to select dermatomes with
minimal additional patient risk and as such, have become routine components of opioid-sparing
intraoperative and postoperative pain management plans for non-cardiac surgical patients at a
single institution. In addition to the postulated benefit of reducing overall opioid exposure
(and potentially reducing the risk for long term physiologic and behavioral dependence upon
opioids), regional anesthetics may allow for earlier extubation after selected surgeries,
shorter intensive care unit (ICU) stays, shorter inpatient admissions, earlier mobilization,
fewer gastrointestinal complications, and improved patient and care team satisfaction scores.
Historically, regional anesthetics have been avoided in cardiac surgery as most patients are
pharmacologically anticoagulated during their procedures and are thus at increased risk for
bleeding. This is particularly worrisome in the pediatric cardiac surgical population as many
of these children remain intubated for an extended period of time postoperatively and
therefore may not have reliable neurological exams in the setting of neuraxial regional
anesthetics-potentially resulting in unrecognized hemorrhage-related acquired neurological
deficits.
Recently, the erector spinae block (ESB) has become popular for providing analgesia after a
number of anterior chest and abdominal procedures. This simple interfascial plane block can
reliably provide unilateral chest and/or abdominal wall analgesia. It has been described in
numerous case reports and case series as an effective block for management of unilateral
thoracotomies, unilateral rib fractures, unilateral abdominal incisions and most notably, for
management of post-sternotomy pain when applied bilaterally. New case reports and series
involving the ESB are being published almost weekly with a growing number of manuscripts
specific to cardiac surgical applications. Indeed, numerous randomized controlled trials have
investigated the analgesic efficacy of bilateral erector spinae plane blocks (BESB) compared
with conventional treatment for pain after cardiac surgery in adult patients and have been
published recently (2018-2019) with promising results.
As an interfascial plane block in a compressible anatomical space, the ESB is considered safe
in anticoagulated (or recently anticoagulated) patients. It is fast becoming a preferred
anesthetic option at BCH for anticoagulated patients - as opposed to neuraxial (e.g.
epidural) and paraneuraxial blocks (i.e. paravertebral) nerve blocks, which are largely
contraindicated in this setting. Further, given its relative ease of placement, apparent
efficacy and safety profile, it is increasingly becoming a standard option for patients
undergoing a wide range of thoracic, abdominal and thoraco-abdominal procedures.
The investigators recently investigated the feasibility of performing these blocks
bilaterally in a pediatric cardiac surgical population undergoing sternotomy-based procedures
(IRB-P00031524). At the conclusion of this 10-patient pilot, the investigators found that
performing these blocks was technically feasible, requiring 30 minutes or less of OR time,
resulting in no known complications. Furthermore, the data suggested an approximate 25%
reduction in rescue opioid requirements in the first 48 hours amongst the erector spinae
group (p=0.048).
In order to best evaluate the efficacy of this block in the pediatric cardiac population, a
blinded, randomized and controlled trial would be ideal. However, given that randomization
could be challenging and the fact that blinding would not be feasible, the investigators
believe an observational prospective cohort study is most appropriate at this time.
As such, the investigators propose to evaluate the comparative efficacy of BESB versus
matched historical controls who received standard of care pain management (systemic opioid
therapy) for patients undergoing cardiac surgery via sternotomy by means of a single arm,
open label, interventional study that will compare as the primary outcome rescue analgesic
requirements, rendered as opiate equivalents, at 12, 24 and 48 hours, and the 24 hour period
preceding both 72 and 96 hours postoperatively. 'Efficacy' will be considered as a threshold
of clinical significance being defined as a 15% difference). In addition to the primary
endpoint, we plan to evaluate the duration of intubation, length of ICU stay, median pain
scores, incidence of PONV (postoperative nausea and vomiting; 0-6h, 6-12h and overall), time
to mobilization and adverse events between these groups. Postoperative data collected from
standard clinical follow-up tools, such as return to baseline sleep and activity status as
well as pain medication requirements at home, will also be compared. In addition, the
investigators plan to evaluate the quality of sleep and activity with a smart watch (Fitbit™
) during the perioperative period in the BESB group only.