Continuous Erector Spinae Block Versus Continuous Paravertebral Block

NCT03768440 | Terminated Phase 3 Results FDA Drug

• 1 other identifier: IRB-P00030317
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Overall Aim: To evaluate the efficacy of continuous erector spinae block (ESB) versus continuous paravertebral block (PVB) for postoperative analgesia in children and adolescents undergoing surgical procedures via unilateral thoracotomy. Hypothesis: The investigators hypothesize that ESP block efficacy is not inferior to that of PVB with respect to pain control and consumed opiate equivalents at 24 hours postoperatively.

Conditions

Pain, Postoperative

Keywords

ropivacaine infusion; regional anesthesia; paravertebral block; erector spinae block

Outcome Measures

Primary Outcomes (1)

• Rescue Analgesic Consumption

  rescue opiates (rendered as morphine equivalents/kg) given by blinded providers using standard PCA/NCA demand protocols

  24 hours

Study Arms (2)

continuous erector spinae block

EXPERIMENTAL

An erector spinae block is placed at end of the thoracotomy 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. Rescue analgesic consumption will be tabulated at 24, 48 and 72 hours, rendered as total opiate equivalents.

Procedure: continuous erector spinae block (ESB); Drug: Ropivacaine

continuous paravertebral block

ACTIVE COMPARATOR

A paravertebral block is placed at end of the thoracotomy 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. Rescue analgesic consumption will be tabulated at 24, 48 and 72 hours, rendered as total opiate equivalents.

Procedure: continuous paravertebral block (PVB); Drug: Ropivacaine

Interventions

continuous erector spinae block (ESB) PROCEDURE

Erector spinae block: 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.

Also known as: ESB with ropivacaine, Naropin

continuous erector spinae block

continuous paravertebral block (PVB) PROCEDURE

The paravertebral space (bound medially by the bodies of the vertebrae, intervertebral discs, and intervertebral foraminae; anterolaterally by the parietal pleura and the innermost intercostal membrane; posteriorly by the transverse processes of the thoracic vertebrae, heads of the ribs, and the superior costotransverse ligament) laying between T4/5 is identified using the ultrasound transducer in a transverse orientation; the needle tip is advanced until it is seen passing under the transverse process, immediately superior to the pleura; the pleura is seen to deflect downward 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.

Also known as: PVB with ropivacaine, Naropin

continuous paravertebral block

Ropivacaine DRUG

Ropivacaine 0.2% will be the drug used for each group (ESB group and PVB group)

Also known as: Naropin

continuous erector spinae block; continuous paravertebral block

Eligibility Criteria

• Age: 1 Month - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• ASA I - III status, undergoing unilateral thoracotomy for either esophageal atresia related intrathoracic procedures or other non-cardiac general surgical intrathoracic procedures.

You may not qualify if:

• Patients undergoing procedures including pleurodesis, pleural stripping, and decortication or other procedures with widely distributed pleural disruption.
• 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; PVB protocol

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 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate in Perioperative Anesthesia, Department of Anesthesiology, Perioperative and Pain Medicine Instructor in Anaesthesia, Havard Medical School

Study Record Dates

• First Submitted: November 16, 2018
• First Posted: December 7, 2018
• Study Start: April 16, 2019
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: May 13, 2026
• Results First Posted: May 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)