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 Hospital24 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Serratus Anterior Plane Block Transversus Thoracis Plane Block Subcutaneous ICD

Interventions

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

Standard local infiltration techniquePROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Postoperative pain score measured

by Numerical Rating Scale pain (0-10), 0 is no pain, 10 is the worst

Time frame: 1 day

Secondary Outcomes

Intraoperative pain score measured

by Numerical Rating Scale pain

Time frame: Intraoperative

Intraoperative sedation score

Richmond Agitation Sedation Scale (RASS) (+4 to -5) +4 combative -5 unarousable

Time frame: Intraoperative

Total local anesthetic volume used

Time frame: Intraoperative

Procedure duration

Time frame: Intraoperative

Intraoperative hemodynamics

Time frame: Intraoperative

Time to 1st rescue pain medication

Time to 1st rescue pain medication after surgery

Time frame: 1 day

Postoperative opioid consumption

Amount of opioids consumed after surgery

Time frame: 1 day

Patient satisfaction

How much is the patient satisfied with the pain management in the perioperative period

Time frame: 1 day

Block related complications

Any complications that may happen from either blocks, e.g infection, bleeding

Time frame: 1 day

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes