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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05092490
Enrollment
24
Registered
2021-10-25
Start date
2021-02-24
Completion date
2023-06-30
Last updated
2023-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Serratus Anterior Plane Block, Subcutaneous ICD, Transversus Thoracis Plane Block

Keywords

Serratus anterior plane block, Transversus thoracis plane block, SICD

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.

Interventions

PROCEDURECombined 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

PROCEDUREStandard 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.

Sponsors

New York Presbyterian Brooklyn Methodist Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, 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

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative pain score measured1 dayby Numerical Rating Scale pain (0-10), 0 is no pain, 10 is the worst

Secondary

MeasureTime frameDescription
Intraoperative sedation scoreIntraoperativeRichmond Agitation Sedation Scale (RASS) (+4 to -5) +4 combative -5 unarousable
Total local anesthetic volume usedIntraoperativeTotal local anesthetic volume used
Procedure durationIntraoperativeProcedure duration
Intraoperative hemodynamicsIntraoperativeIntraoperative hemodynamics
Intraoperative pain score measuredIntraoperativeby Numerical Rating Scale pain
Postoperative opioid consumption1 dayAmount of opioids consumed after surgery
Patient satisfaction1 dayHow much is the patient satisfied with the pain management in the perioperative period
Block related complications1 dayAny complications that may happen from either blocks, e.g infection, bleeding
Time to 1st rescue pain medication1 dayTime to 1st rescue pain medication after surgery

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026