Serratus Anterior Plane Block Combined With Transversus Thoracic Muscle Plane Block Versus Conventional Local Anesthetic Infiltration for SICD Implantation: A Randomized Controlled Trial
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
Joel Yarmush
Program Director, Department of Anesthesiology, Principal Investigator, Clinical Professor
New York Presbyterian Brooklyn Methodist Hospital