Phase 3
Completed N=10
Bilateral Continuous Erector Spinae Blocks for Post-Sternotomy Pain Management: A Pilot Study
Pain, Postoperative
Source: ClinicalTrials.gov NCT03936387 ↗
Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcomePrimary: Number of Participants Who Completed a Successful Intervention With No Major Adverse Events — 10 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
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 | — |
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. Informational only — not medical advice.