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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-24

Study Completion Date

2023-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Serratus Anterior Plane Block Transversus Thoracis Plane Block Subcutaneous ICD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Participants are not informed about which block they are receiving

1 study personnel assess the pain scores and patient satisfaction postoperative

Study Groups

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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

Group Type EXPERIMENTAL

Combined serratus anterior plane block and transversus thoracis plane block

Intervention Type PROCEDURE

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

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.

Group Type ACTIVE_COMPARATOR

Standard local infiltration technique

Intervention Type PROCEDURE

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.

Interventions

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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

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patient is able to provide a written informed consent.
* Patient is scheduled to have an elective SICD implantation procedure.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes