Serratus Anterior Plane Block Combined With Transversus Thoracic Muscle Plane Block Versus Conventional Local Anesthetic Infiltration for SICD Implantation: A Randomized Controlled Trial

New York Presbyterian Brooklyn Methodist Hospital

Status: Completed

Conditions: Transversus Thoracis Plane Block; Serratus Anterior Plane Block; Subcutaneous ICD

Treatments: Procedure: Standard local infiltration technique; Procedure: Combined serratus anterior plane block and transversus thoracis plane block

Study type: Interventional

Funder types: Other

Identifiers

NCT05092490

1723038-1

Details and patient eligibility

About

This is a prospective randomized study. The aim is to investigate the efficacy of a combined SAPB with TTPB for perioperative pain control compared to the standard local anesthetic infiltration technique in adult patients undergoing SICD implantation. The hypothesis is that the combined plane block provides better pain control compared to the standard local infiltration technique.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patient is able to provide a written informed consent.
• Patient is scheduled to have an elective SICD implantation procedure.
• Patient has none of the exclusion criteria

Exclusion criteria

• Patient is unable to provide a written informed consent.
• Patient is younger than 18 years old.
• Patients with prior thoracotomy or other thoracic surgery altering anatomy.
• Patients with neurological deficits.
• Patients with impaired coagulation (Platelet count < 50,000 cells/mcl and/or INR > 1.4).
• Patient on anticoagulation therapy.
• Patient's weight below 50 kg

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 2 patient groups

Combined serratus anterior plane block and transversus thoracis plane block

Experimental group

Description:

The study group will receive a combined plane block by a dedicated anesthesia team prior to their procedure. 20 mL of local anesthetic (0.25% bupivacaine) will be injected for the Serratus anterior plane block and another 20 mL of local anesthetic (0.25% bupivacaine) will be injected in transversus thoracis plane block

Treatment:

Procedure: Combined serratus anterior plane block and transversus thoracis plane block

Stand local anesthetic infiltration

Active Comparator group

Description:

Local anesthetic infiltration of the incision sites will be performed by the cardiologist prior to, and as, necessary during the procedure. The amount of local anesthetic used will be determined intraoperatively by the cardiologist according to the patients' requirements.

Treatment:

Procedure: Standard local infiltration technique