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

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 Overview

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

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Brooklyn, New York, United States, 11215
      • New York Methodist Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Procedure: 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
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain score measured	by Numerical Rating Scale pain (0-10), 0 is no pain, 10 is the worst	1 day

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: New York Presbyterian Brooklyn Methodist Hospital

Publications and helpful links

General Publications

• Burke MC, Gold MR, Knight BP, Barr CS, Theuns DAMJ, Boersma LVA, Knops RE, Weiss R, Leon AR, Herre JM, Husby M, Stein KM, Lambiase PD. Safety and Efficacy of the Totally Subcutaneous Implantable Defibrillator: 2-Year Results From a Pooled Analysis of the IDE Study and EFFORTLESS Registry. J Am Coll Cardiol. 2015 Apr 28;65(16):1605-1615. doi: 10.1016/j.jacc.2015.02.047.
• Weiss R, Knight BP, Gold MR, Leon AR, Herre JM, Hood M, Rashtian M, Kremers M, Crozier I, Lee KL, Smith W, Burke MC. Safety and efficacy of a totally subcutaneous implantable-cardioverter defibrillator. Circulation. 2013 Aug 27;128(9):944-53. doi: 10.1161/CIRCULATIONAHA.113.003042.
• Essandoh MK, Otey AJ, Abdel-Rasoul M, Stein EJ, Turner KR, Joseph NC, Daoud EG. Monitored Anesthesia Care for Subcutaneous Cardioverter-Defibrillator Implantation: A Single-Center Experience. J Cardiothorac Vasc Anesth. 2016 Oct;30(5):1228-33. doi: 10.1053/j.jvca.2016.06.007. Epub 2016 Jun 8.
• Afzal MR, Okabe T, Koppert T, Tyler J, Houmsse M, Augostini RS, Hummel JD, Kalbfleisch SJ, Iyer MH, Flores AS, Bhandary S, Dimitrova G, Elsayed-Awad H, Fiorini K, Gorelik L, Perez W, Saklayen S, Stein E, Turner K, Franklin NP, Ryu JN, Bhatt A, Weiss R, Daoud EG, Essandoh M. Implantation of subcutaneous defibrillator is feasible and safe with monitored anesthesia care. Pacing Clin Electrophysiol. 2019 Dec;42(12):1552-1557. doi: 10.1111/pace.13838. Epub 2019 Nov 18.
• Ziacchi M, Bisignani G, Palmisano P, Scalone A, Martignani C, Elvira Mocavero P, Caravati F, Della Cioppa N, Mazzuero A, Pecora D, Vicentini A, Landolina ME, Debonis S, Scimia P, Lovecchio M, Valsecchi S, Diemberger I, Droghetti A. Serratus anterior plane block in subcutaneous implantable cardioverter defibrillator implantation: A case-control analysis. J Cardiovasc Electrophysiol. 2020 Jan;31(1):144-149. doi: 10.1111/jce.14293. Epub 2019 Dec 3.
• Miller MA, Garg J, Salter B, Brouwer TF, Mittnacht AJ, Montgomery ML, Honikman R, Arkonac DE, Choudry S, Dukkipati SR, Reddy VY, Weiner MM. Feasibility of subcutaneous implantable cardioverter-defibrillator implantation with opioid sparing truncal plane blocks and deep sedation. J Cardiovasc Electrophysiol. 2019 Jan;30(1):141-148. doi: 10.1111/jce.13750. Epub 2018 Oct 22.
• Uran C, Giojelli A, Borgogna DA, Morello G, Marullo F, Iodice P, Greco A, Accogli M, Guido A, Palmisano P. Ultrasound-guided serratus anterior plane block combined with parasternal block in subcutaneous implantable cardioverter defibrillator implantation: Results of a pilot study. Pacing Clin Electrophysiol. 2020 Jul;43(7):705-712. doi: 10.1111/pace.13944. Epub 2020 Jun 3.

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2021
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: October 13, 2021
• First Submitted That Met QC Criteria: October 13, 2021
• First Posted (Actual): October 25, 2021

Study Record Updates

• Last Update Posted (Estimated): November 14, 2023
• Last Update Submitted That Met QC Criteria: November 13, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Serratus anterior plane block; Transversus thoracis plane block; SICD
• Other Study ID Numbers: 1723038-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No