Clinical trial NCT05092490: Serratus Anterior Plane Block Combined With Transversus Thoracic Muscle Plane Block Versus Conventional Local Anesthetic Infiltration for SICD Implantation: A Randomized Controlled 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Serratus Anterior Plane Block
Transversus Thoracis Plane Block
Subcutaneous ICD
Keywords: Serratus anterior plane block
Transversus thoracis plane block
SICD
Lead sponsor: New York Presbyterian Brooklyn Methodist Hospital
Sponsor class: OTHER
First posted: 2021-10-25
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Postoperative pain score measured
timeFrame: 1 day
Secondary outcomes:
measure: Intraoperative pain score measured
timeFrame: Intraoperative
measure: Intraoperative sedation score
timeFrame: Intraoperative
measure: Total local anesthetic volume used
timeFrame: Intraoperative
measure: Procedure duration
timeFrame: Intraoperative
measure: Intraoperative hemodynamics
timeFrame: Intraoperative
measure: Time to 1st rescue pain medication
timeFrame: 1 day
measure: Postoperative opioid consumption
timeFrame: 1 day
measure: Patient satisfaction
timeFrame: 1 day
measure: Block related complications
timeFrame: 1 day
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: New York Methodist Hospital
state: New York
Study officials:
References:
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 IDE Study and EFFORTLESS Registry. J Am Coll Cardiol. 2015 Apr 28;65(16):1605-1615. doi: 10.1016/j.jacc.2015.02.047.
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/CIRCULATIONAHA.113.003042.
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: 10.1053/j.jvca.2016.06.007. Epub 2016 Jun 8.
citation: 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.
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 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.
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 blocks and deep sedation. J Cardiovasc Electrophysiol. 2019 Jan;30(1):141-148. doi: 10.1111/jce.13750. Epub 2018 Oct 22.
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: Results of a pilot study. Pacing Clin Electrophysiol. 2020 Jul;43(7):705-712. doi: 10.1111/pace.13944. Epub 2020 Jun 3.