- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04567407
Bilateral Continuous Erector Spinae Blocks for Post-Sternotomy Pain Management
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Massachusetts
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Boston, Massachusetts, United States, 02118
- Boston Children"S Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Scheduled as part of the cardiac surgical ERAS program: Patients scheduled for elective surgeries for the following congenital anomalies, or similar: atrial septal defects (all types), partial anomalous pulmonary venous connection (non-obstructed), cor-triatriatum, VSD, partial AV canal, sub-aortic membrane resection, anomalous aortic origin of the coronary arteries, and pulmonary valve/conduit implantation
- Scheduled for a primary sternotomy.
- Ages 2 years through 17 years.
Exclusion Criteria:
- Single ventricle physiology.
- Significant scoliosis or other anatomic contraindications to ESB.
- Significant intraoperative hemodynamic instability or bleeding, as ascertained by clinicians taking care of the patient.
- Patients with severe neurodevelopmental delays.
- Patients with previous chronic pain syndromes.
- Patients with a history of greater than 24 hours of postoperative or post-procedural opioid treatment at any point in the 2 months prior to surgery.
- Lack of parental consent and/or child assent.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Bilateral erector spinae blocks
All enrolled patients will have bilateral erector spinae blocks (with catheters for postoperative local anesthetic infusion) placed by the by a member of the clinical regional anesthesia team (under the supervision of a member of the research team) in a sterile fashion after the cardiac surgical procedure is completed.
Postoperative continuous infusion of local anesthetic (ropivacaine) via the nerve block catheter is initiated and managed by the Acute Pain Service (per standardized, clinical weight-based protocols).
|
Bilateral chest wall nerve blocks using ropivacaine.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Analgesic Requirement
Time Frame: 24hours postop
|
Total opiate equivalents
|
24hours postop
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Analgesic Requirement
Time Frame: 48hours postop
|
Total opiate equivalents
|
48hours postop
|
Analgesic Requirement
Time Frame: 96hours postop
|
Total opiate equivalents
|
96hours postop
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration of Mechanical Ventilation/Intubation
Time Frame: 48hrs
|
Length of postoperative mechanical ventilation/intubation following OR exit
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48hrs
|
Length of Postoperative ICU Stay
Time Frame: 72Hours
|
Duration of ICU stay following OR exit
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72Hours
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Length of Hospital Stay
Time Frame: 5 Days
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Duration of Inpatient hospital admission
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5 Days
|
Median Pain Scores
Time Frame: day of surgery (POD 0) 7:00am - 18:59pm
|
Patient reported pain scores using either NRS score (numeric rating scale of 1-10, with 10 being the worst pain), the INRS score (individualized numeric rating scale of 1-10, with 10 being the worst pain) or FLACC scale (face, legs, activity, cry, consolability scale of 0-10 with 10 being the worst pain).
Patients were assessed multiple times (variably - per routine clinical practice, every few hours during the Time Frame) in order to derive a median for each participant per 12h period.
Median pain scores were used rather than time specific pain scores to compare patients in the single arm cohort study to controls from the ERAS controls.
Median pain scores were averaged across all participants in the intervention arm as well as the controls.
Outcomes are reported as mean with the standard error.
|
day of surgery (POD 0) 7:00am - 18:59pm
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Median Pain Scores
Time Frame: night of surgery (PON 0) 19:00pm-6:59am
|
Patient reported pain scores using either NRS score (numeric rating scale of 1-10, with 10 being the worst pain), the INRS score (individualized numeric rating scale of 1-10, with 10 being the worst pain) or FLACC scale (face, legs, activity, cry, consolability scale of 0-10 with 10 being the worst pain).
Patients were assessed multiple times (variably - per routine clinical practice, every few hours during the Time Frame) in order to derive a median for each participant per 12h period.
Median pain scores were used rather than time specific pain scores to compare patients in the single arm cohort study to controls from the ERAS controls.
Median pain scores were averaged across all participants in the intervention arm as well as the controls.
Outcomes are reported as mean with the standard error.
|
night of surgery (PON 0) 19:00pm-6:59am
|
Median Pain Scores
Time Frame: Post-Op Day 1 (7:00am-18:59pm)
|
Patient reported pain scores using either NRS score (numeric rating scale of 1-10, with 10 being the worst pain), the INRS score (individualized numeric rating scale of 1-10, with 10 being the worst pain) or FLACC scale (face, legs, activity, cry, consolability scale of 0-10 with 10 being the worst pain).
Patients were assessed multiple times (variably - per routine clinical practice, every few hours during the Time Frame) in order to derive a median for each participant per 12h period.
Median pain scores were used rather than time specific pain scores to compare patients in the single arm cohort study to controls from the ERAS controls.
Median pain scores were averaged across all participants in the intervention arm as well as the controls.
Outcomes are reported as mean with the standard error.
|
Post-Op Day 1 (7:00am-18:59pm)
|
Median Pain Scores
Time Frame: Post-Op Night 1 (19:00pm-6:59am)
|
Patient reported pain scores using either NRS score (numeric rating scale of 1-10, with 10 being the worst pain), the INRS score (individualized numeric rating scale of 1-10, with 10 being the worst pain) or FLACC scale (face, legs, activity, cry, consolability scale of 0-10 with 10 being the worst pain).
Patients were assessed multiple times (variably - per routine clinical practice, every few hours during the Time Frame) in order to derive a median for each participant per 12h period.
Median pain scores were used rather than time specific pain scores to compare patients in the single arm cohort study to controls from the ERAS controls.
Median pain scores were averaged across all participants in the intervention arm as well as the controls.
Outcomes are reported as mean with the standard error.
|
Post-Op Night 1 (19:00pm-6:59am)
|
Time to First Mobilization
Time Frame: 48 hours
|
Time to out of bed activity (e.g., up to chair, ambulation)
|
48 hours
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: ROLAND BRUSSEAU, MD, Boston Children's Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-P00034302
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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