Bilateral Continuous Erector Spinae Blocks for Post-Sternotomy Pain Management

NCT04567407 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: IRB-P00034302
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the efficacy of bilateral continuous erector spinae blocks (BESB) for postoperative analgesia in children and adolescents undergoing cardiac surgical procedures via sternotomy in the Early Recovery After Surgery (ERAS) program in a single arm, open label, interventional study.

Conditions

Postoperative Pain

Keywords

regional anesthesia; cardiac surgery; erector spinae

Outcome Measures

Primary Outcomes (3)

• Analgesic Requirement

  Total opiate equivalents

  24hours postop

• Analgesic Requirement

  Total opiate equivalents

  48hours postop

• Analgesic Requirement

  Total opiate equivalents

  96hours postop

Secondary Outcomes (8)

• Duration of Mechanical Ventilation/Intubation

  48hrs

• Length of Postoperative ICU Stay

  72Hours

• Length of Hospital Stay

  5 Days

• Median Pain Scores

  day of surgery (POD 0) 7:00am - 18:59pm

• Median Pain Scores

  night of surgery (PON 0) 19:00pm-6:59am

Study Arms (1)

Bilateral erector spinae blocks

EXPERIMENTAL

All enrolled patients will have bilateral erector spinae blocks (with catheters for postoperative local anesthetic infusion) placed by the by a member of the clinical regional anesthesia team (under the supervision of a member of the research team) in a sterile fashion after the cardiac surgical procedure is completed. Postoperative continuous infusion of local anesthetic (ropivacaine) via the nerve block catheter is initiated and managed by the Acute Pain Service (per standardized, clinical weight-based protocols).

Drug: Bilateral erector spinae blocks using ropivacaine

Interventions

Bilateral erector spinae blocks using ropivacaine DRUG

Bilateral chest wall nerve blocks using ropivacaine.

Also known as: Naropin

Bilateral erector spinae blocks

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Scheduled as part of the cardiac surgical ERAS program: Patients scheduled for elective surgeries for the following congenital anomalies, or similar: atrial septal defects (all types), partial anomalous pulmonary venous connection (non-obstructed), cor-triatriatum, VSD, partial AV canal, sub-aortic membrane resection, anomalous aortic origin of the coronary arteries, and pulmonary valve/conduit implantation
• Scheduled for a primary sternotomy.
• Ages 2 years through 17 years.

You may not qualify if:

• Single ventricle physiology.
• Significant scoliosis or other anatomic contraindications to ESB.
• 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 greater than 24 hours of postoperative or post-procedural 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

857-218-4814

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 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Regional Anesthesia Program

Model Details: Prospective single-arm intervention trial

Study Record Dates

• First Submitted: September 18, 2020
• First Posted: September 28, 2020
• Study Start: September 22, 2020
• Primary Completion: January 22, 2022
• Study Completion: January 22, 2022
• Last Updated: October 17, 2023
• Results First Posted: October 17, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)