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

NCT03936387 | Completed Phase 3 Results FDA Drug

• 1 other identifier: IRB-P00031524
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain, Postoperative

Keywords

erector spinae block; regional anesthesia; sternotomy; ropivacaine

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Completed a Successful Intervention With No Major Adverse Events

  For this study, 'feasibility' will be defined primarily as a successful intervention completion rate of 75% or greater of all subjects with no major adverse outcomes.

  48 hours

Secondary Outcomes (1)

• Number of Participants Who Completed a Successful Intervention With a Full Data Set

  48 hours

Study Arms (1)

Bilateral erector spinae blocks

EXPERIMENTAL

Bilateral erector spinae block catheters are placed at end of the sternotomy procedure, bolused with 1ml/kg 0.2% ropivacaine, then started on a 0.2ml/kg/hour continuous infusion of 0.2% ropivacaine. Patients will have access to rescue opiates as needed by means of the standard PCA/NCA demand protocols utilized at BCH.

Drug: Ropivacaine

Interventions

Ropivacaine DRUG

Erector spinae blocks: T4/5 transverse process is identified with the ultrasound transducer in a parasagittal orientation; the needle tip is advanced until it contacts the transverse process, just below the erector spinae muscle complex; the erector spinae muscle is visualized to be elevated up off of the transverse process with normal saline injection. Following a bolus injection of 2ml/kg of 0.2% ropivacaine, a catheter is threaded into the space occupied by the local anesthetic bolus. Repeated on contralateral side.

Also known as: Naropin

Bilateral erector spinae blocks

Eligibility Criteria

• Age: 3 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

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.

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children"S Hospital

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: ROLAND BRUSSEAU MD
• Organization: BOSTON CHILDREN'S HOSPITAL

roland.brusseau@childrens.harvard.edu

6173557737

Study Officials

• ROLAND BRUSSEAU, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: SeniorAssociate in Perioperative Anesthesia, Department of Anesthesiology, Perioperative and Pain Medicine Instructor in Anaesthesia, Harvard Medical School

Model Details: Single intervention group, bilateral erector spinae blocks with 0.2% ropivacaine, to assess the feasibility of this technique for postoperative pain control following surgeries involving sternotomies in children.

Study Record Dates

• First Submitted: May 1, 2019
• First Posted: May 3, 2019
• Study Start: July 1, 2019
• Primary Completion: September 1, 2019
• Study Completion: September 12, 2019
• Last Updated: April 5, 2021
• Results First Posted: April 5, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)