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Completed

NCT Number: NCT05092490

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

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.

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Key information

Conditions

Serratus Anterior Plane Block Subcutaneous ICD Transversus Thoracis Plane Block

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York Methodist Hospital

Brooklyn, New York, 11215, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Combined serratus anterior plane block and transversus thoracis plane block

Procedure

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

Standard local infiltration technique

Procedure

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.

Primary outcomes

  1. 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

  1. Intraoperative pain score measured

    Time frame: Intraoperative

    by Numerical Rating Scale pain

  2. Intraoperative sedation score

    Time frame: Intraoperative

    Richmond Agitation Sedation Scale (RASS) (+4 to -5) +4 combative

    -5 unarousable

  3. Total local anesthetic volume used

    Time frame: Intraoperative

    Total local anesthetic volume used

  4. Procedure duration

    Time frame: Intraoperative

    Procedure duration

  5. Intraoperative hemodynamics

    Time frame: Intraoperative

    Intraoperative hemodynamics

  6. Time to 1st rescue pain medication

    Time frame: 1 day

    Time to 1st rescue pain medication after surgery

  7. Postoperative opioid consumption

    Time frame: 1 day

    Amount of opioids consumed after surgery

  8. Patient satisfaction

    Time frame: 1 day

    How much is the patient satisfied with the pain management in the perioperative period

  9. Block related complications

    Time frame: 1 day

    Any complications that may happen from either blocks, e.g infection, bleeding

Sponsors and collaborators

Lead sponsor

New York Presbyterian Brooklyn Methodist Hospital

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 25, 2021
Registry last updated
Nov 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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