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Clinical Trials/NCT05092490
NCT05092490CompletedNot Applicable

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

New York Presbyterian Brooklyn Methodist Hospital2 sites in 1 country24 target enrollmentStarted: February 24, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
24
Locations
2
Primary Endpoint
Postoperative pain score measured

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Masking Description

Participants are not informed about which block they are receiving

1 study personnel assess the pain scores and patient satisfaction postoperative

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

Postoperative pain score measured

Time Frame: 1 day

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

Secondary Outcomes

  • Patient satisfaction(1 day)
  • Intraoperative pain score measured(Intraoperative)
  • Intraoperative sedation score(Intraoperative)
  • Total local anesthetic volume used(Intraoperative)
  • Procedure duration(Intraoperative)
  • Intraoperative hemodynamics(Intraoperative)
  • Time to 1st rescue pain medication(1 day)
  • Block related complications(1 day)
  • Postoperative opioid consumption(1 day)

Investigators

Sponsor
New York Presbyterian Brooklyn Methodist Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Joel Yarmush

Program Director, Department of Anesthesiology, Principal Investigator, Clinical Professor

New York Presbyterian Brooklyn Methodist Hospital

Study Sites (2)

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