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

Serratus Anterior Plane Block Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05092490
• Other study ID #: 1723038-1
• Status: Completed
• Phase: N/A
• Start date: February 24, 2021
• Est. completion date: June 30, 2023

Study information

• Verified date: November 2023
• Source: New York Presbyterian Brooklyn Methodist Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Serratus Anterior Plane Block

Intervention

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
• 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.

Locations

Country	Name	City	State
United States	New York Methodist Hospital	Brooklyn	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York Presbyterian Brooklyn Methodist Hospital

Country where clinical trial is conducted

United States, 

References & Publications (7)

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, Da — View Citation

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 — View Citation

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: 10.105 — View Citation

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 b — View Citation

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: — View Citation

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 — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain score measured	by Numerical Rating Scale pain (0-10), 0 is no pain, 10 is the worst	1 day
Secondary	Intraoperative pain score measured	by Numerical Rating Scale pain	Intraoperative
Secondary	Intraoperative sedation score	Richmond Agitation Sedation Scale (RASS) (+4 to -5) +4 combative; -5 unarousable	Intraoperative
Secondary	Total local anesthetic volume used	Total local anesthetic volume used	Intraoperative
Secondary	Procedure duration	Procedure duration	Intraoperative
Secondary	Intraoperative hemodynamics	Intraoperative hemodynamics	Intraoperative
Secondary	Time to 1st rescue pain medication	Time to 1st rescue pain medication after surgery	1 day
Secondary	Postoperative opioid consumption	Amount of opioids consumed after surgery	1 day
Secondary	Patient satisfaction	How much is the patient satisfied with the pain management in the perioperative period	1 day
Secondary	Block related complications	Any complications that may happen from either blocks, e.g infection, bleeding	1 day