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Serratus Anterior Plane BlockNCT05092490

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

A study testing Combined serratus anterior plane block and transversus thoracis plane block and Standard local infiltration technique in people with Serratus Anterior Plane Block and Transversus Thoracis Plane Block, run by New York Presbyterian Brooklyn Methodist Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Combined serratus anterior plane block and transversus thoracis plane block and Standard local infiltration technique
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteUnited States
Study dates
24 Feb 2021to 30 Jun 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • New York Methodist Hospital

    Brooklyn, New York, 11215

Other trials in United States

About this study

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.

Being tested
Combined serratus anterior plane block and transversus thoracis plane block, Standard local infiltration technique
Keywords
Serratus anterior plane block, Transversus thoracis plane block, SICD

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Combined serratus anterior plane block and transversus thoracis plane blockProcedure or surgery

    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 techniqueProcedure or surgery

    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.

Study groups in NCT05092490
Study groupRoleWhat they receive
Combined serratus anterior plane block and transversus thoracis plane blockExperimentalThe 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
Receives: Procedure: Combined serratus anterior plane block and transversus thoracis plane block
Stand local anesthetic infiltrationActive comparatorLocal 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.
Receives: Procedure: Standard local infiltration technique

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postoperative pain score measured

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

    Measured: 1 day

Secondary outcomes (9)

  1. Intraoperative pain score measured

    by Numerical Rating Scale pain

    Measured: Intraoperative

  2. Intraoperative sedation score

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

    -5 unarousable

    Measured: Intraoperative

  3. Total local anesthetic volume used

    Total local anesthetic volume used

    Measured: Intraoperative

  4. Procedure duration

    Procedure duration

    Measured: Intraoperative

  5. Intraoperative hemodynamics

    Intraoperative hemodynamics

    Measured: Intraoperative

  6. Time to 1st rescue pain medication

    Time to 1st rescue pain medication after surgery

    Measured: 1 day

  7. Postoperative opioid consumption

    Amount of opioids consumed after surgery

    Measured: 1 day

  8. Patient satisfaction

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

    Measured: 1 day

  9. Block related complications

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

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Oct 2021
  2. Study start24 Feb 2021
  3. Primary completion30 Jun 2023
  4. Study completion30 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05092490
Sponsor's protocol ID
1723038-1
Status last verified
Nov 2023
First submitted
13 Oct 2021
Last updated
14 Nov 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 25908064

  • 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.

    PubMed 23979626

  • 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.

    PubMed 27640893

  • 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.

    PubMed 31702059

  • 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.

    PubMed 31778266

  • 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.

    PubMed 30230098

  • 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.

    PubMed 32420626

Questions about this trial

What is this clinical trial studying?

A study testing Combined serratus anterior plane block and transversus thoracis plane block and Standard local infiltration technique in people with Serratus Anterior Plane Block and Transversus Thoracis Plane Block, run by New York Presbyterian Brooklyn Methodist Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative pain score measured (time frame: 1 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05092490, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2023.

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