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

Completed · Phase 3

Conditions studied: Pain, Postoperative

In brief

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.

Key facts

Study ID

NCT03936387

Run by

Boston Children's Hospital

People needed

10

Starts

2019-07-01

Expected to finish

2019-09-12

Last updated by the study team

2021-04-05

Who can join

Age: 3 and older, up to 21. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Scheduled as part of the cardiac surgical ERAS program.
• Scheduled for a primary sternotomy.
• Ages 3-21 years.

You may not qualify if…

• 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.

Where it is running

• Boston Children"S Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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