Phase 4
N=45
Bilateral Continuous Erector Spinae Blocks for Post-Sternotomy Pain Management
Postoperative Pain
Bottom Line
View on ClinicalTrials.gov: NCT04567407 ↗Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Oct 2023
Primary outcome: Primary: Analgesic Requirement — 0.60 (mg/kg)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Bilateral erector spinae blocks using ropivacaine (Drug)
- Age
- Pediatric · 2+ yrs
- Sex
- All
- Sponsor
- Boston Children's Hospital
- Primary completion
- Jan 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Analgesic Requirement |
1.34 | — |
| PRIMARY Analgesic Requirement |
1.34 | — |
| PRIMARY Analgesic Requirement |
1.34 | — |
| SECONDARY Duration of Mechanical Ventilation/Intubation |
0.7 | — |
| SECONDARY Length of Postoperative ICU Stay |
23.3 | — |
| SECONDARY Length of Hospital Stay |
4.10 | — |
| SECONDARY Median Pain Scores |
2.92 | — |
| SECONDARY Median Pain Scores |
2.92 | — |
| SECONDARY Median Pain Scores |
2.92 | — |
| SECONDARY Median Pain Scores |
2.92 | — |
| SECONDARY Time to First Mobilization |
6.75 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04567407). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.