NCT05092490

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 24, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 13, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 25, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

November 14, 2023

Status Verified

November 1, 2023

Enrollment Period

2.3 years

First QC Date

October 13, 2021

Last Update Submit

November 13, 2023

Conditions

Serratus Anterior Plane BlockTransversus Thoracis Plane BlockSubcutaneous ICD

Keywords

Serratus anterior plane blockTransversus thoracis plane blockSICD

Outcome Measures

Primary Outcomes (1)

  • Postoperative pain score measured

    by Numerical Rating Scale pain (0-10), 0 is no pain, 10 is the worst

    1 day

Secondary Outcomes (9)

  • Intraoperative pain score measured

    Intraoperative

  • Intraoperative sedation score

    Intraoperative

  • Total local anesthetic volume used

    Intraoperative

  • Procedure duration

    Intraoperative

  • Intraoperative hemodynamics

    Intraoperative

  • +4 more secondary outcomes

Study Arms (2)

Combined serratus anterior plane block and transversus thoracis plane block

EXPERIMENTAL

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

Stand local anesthetic infiltration

ACTIVE COMPARATOR

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

Interventions

Combined serratus anterior plane block and transversus thoracis plane blockPROCEDURE

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

Combined serratus anterior plane block and transversus thoracis plane block
Standard local infiltration techniquePROCEDURE

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.

Stand local anesthetic infiltration

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York Methodist Hospital

Brooklyn, New York, 11215, United States

Location

Related Publications (7)

  • 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.

    PMID: 25908064RESULT

  • 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.

    PMID: 23979626RESULT

  • 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.

    PMID: 27640893RESULT

  • 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.

    PMID: 31702059RESULT

  • 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.

    PMID: 31778266RESULT

  • 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.

    PMID: 30230098RESULT

  • 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.

    PMID: 32420626RESULT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants are not informed about which block they are receiving 1 study personnel assess the pain scores and patient satisfaction postoperative
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Program Director, Department of Anesthesiology, Principal Investigator, Clinical Professor

Study Record Dates

First Submitted

October 13, 2021

First Posted

October 25, 2021

Study Start

February 24, 2021

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

November 14, 2023

Record last verified: 2023-11

Locations

US(1)