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

Not Applicable

Completed

• Conditions: Transversus Thoracis Plane Block; Serratus Anterior Plane Block; Subcutaneous ICD
• Interventions: Procedure: Combined serratus anterior plane block and transversus thoracis plane block; Procedure: Standard local infiltration technique

• Registration Number: NCT05092490
• Lead Sponsor: New York Presbyterian Brooklyn Methodist Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-24
• Study First Submitted: 2021-10-13
• Study First Submitted QC: 2021-10-13
• Study First Posted: 2021-10-25
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-13
• Last Update Posted: 2023-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combined serratus anterior plane block and transversus thoracis plane block	Combined serratus anterior plane block and transversus thoracis plane block	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
Stand local anesthetic infiltration	Standard local infiltration technique	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.

Primary Outcome Measures

Name	Time	Method
Postoperative pain score measured	1 day	by Numerical Rating Scale pain (0-10), 0 is no pain, 10 is the worst

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction	1 day	How much is the patient satisfied with the pain management in the perioperative period
Intraoperative pain score measured	Intraoperative	by Numerical Rating Scale pain
Intraoperative sedation score	Intraoperative	Richmond Agitation Sedation Scale (RASS) (+4 to -5) +4 combative; -5 unarousable
Total local anesthetic volume used	Intraoperative	Total local anesthetic volume used
Procedure duration	Intraoperative	Procedure duration
Intraoperative hemodynamics	Intraoperative	Intraoperative hemodynamics
Time to 1st rescue pain medication	1 day	Time to 1st rescue pain medication after surgery
Block related complications	1 day	Any complications that may happen from either blocks, e.g infection, bleeding
Postoperative opioid consumption	1 day	Amount of opioids consumed after surgery

Trial Locations

Locations (1)

New York Methodist Hospital; 🇺🇸 Brooklyn, New York, United States