Bilateral Continuous Erector Spinae Blocks for Post-Sternotomy Pain Management: A Pilot Study

• Status: Completed
• Trial end date: 2019-09-12
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Boston Children's Hospital; Boston Children’s Hospital
• Treatments: Ropivacaine

Criteria

Inclusion Criteria:

1. Scheduled as part of the cardiac surgical ERAS program.

2. Scheduled for a primary sternotomy.

3. Ages 3-21 years.

Exclusion Criteria:

1. Patients undergoing reoperative procedures.

2. Significant scoliosis or other anatomic contraindications to ESB.

3. History of bleeding or current therapeutic dose anticoagulant use.

4. Significant intraoperative hemodynamic instability or bleeding, as ascertained by clinicians taking care of the patient.

5. Patients with severe neurodevelopmental delays.

6. Patients with previous chronic pain syndromes.

7. Patients with a history of opioid treatment at any point in the 2 months prior to surgery.

8. Lack of parental consent and/or child assent.