Phase 3
N=10
Bilateral Continuous Erector Spinae Blocks for Post-Sternotomy Pain Management: A Pilot Study
Pain, Postoperative
Bottom Line
View on ClinicalTrials.gov: NCT03936387 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcome: Primary: Number of Participants Who Completed a Successful Intervention With No Major Adverse Events — 10 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ropivacaine (Drug)
- Age
- Pediatric, Adult · 3+ yrs
- Sex
- All
- Sponsor
- Boston Children's Hospital
- Primary completion
- Sep 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Completed a Successful Intervention With No Major Adverse Events |
10 | — |
| SECONDARY Number of Participants Who Completed a Successful Intervention With a Full Data Set |
10 | — |
Summary
Overall Aim: To evaluate the feasibility and potential benefits of investigating bilateral continuous erector spinae blocks (BESB) for postoperative pain management in a small cohort of children undergoing surgical sternotomy prior to planning an appropriately powered, randomized, controlled trial of the same.
Hypothesis: The investigators' primary hypothesis is that utilizing bilateral erector spinae blocks for post-sternotomy pain is a feasible intervention for consideration in a larger trial by demonstrating a 75% or greater successful intervention completion rate without any major adverse outcomes.
Eligibility Criteria
Inclusion Criteria
- Scheduled as part of the cardiac surgical ERAS program.
- Scheduled for a primary sternotomy.
- Ages 3-21 years.
Exclusion Criteria
- Patients undergoing reoperative procedures.
- Significant scoliosis or other anatomic contraindications to ESB.
- History of bleeding or current therapeutic dose anticoagulant use.
- 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 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 (NCT03936387). 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.