Transversus Thoracic Plane Block for Perioperative Analgesia in Cardiac Surgery

NCT ID: NCT06546722

Last Updated: 2024-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-01

Study Completion Date

2025-12-30

Brief Summary

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The goal of this clinical trial is to learn if perioperative Transversus Thoracic Plane Block (TTPB) decrease perioperative pain after cardiac surgery. The main questions it aims to answer are:

1. does Transversus Thoracic Plane Block decrease perioperative pain after cardiac surgery more than the standard analgesic treatment?
2. Are the results different if the investigators perform Transversus Thoracic Plane Block before surgery or at the end of surgery?

Detailed Description

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Conditions

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Transversus Thoracic Plane Block Cardiac Surgery Post Operative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Placebo

This group receives standard analgesic treatment and no Transversus Thoracic Plane Block is performed

Group Type NO_INTERVENTION

No interventions assigned to this group

Transversus Thoracic Plane Block pre

This group receives standard analgesic treatment and Transversus Thoracic Plane Block is performed before surgery

Group Type ACTIVE_COMPARATOR

Transversus Thoracic Plane Block

Intervention Type PROCEDURE

The Transversus Thoracic Plane Block is a recent regional anesthesia technique. It provides analgesia for the anterior cutaneous branches of the intercostal nerves T2-6 to the medial anterior chest wall via a single injection of local anesthesia between the internal intercostal muscle and the transversus thoracic muscle located between the third and fourth (or fourth and fifth) intercostal space. It is noteworthy that the TTPB can consequently reduce pulmonary morbidity and the need for high-dose opioids.

Transversus Thoracic Plane Block post

This group receives standard analgesic treatment and Transversus Thoracic Plane Block is performed at the end of surgery

Group Type ACTIVE_COMPARATOR

Transversus Thoracic Plane Block

Intervention Type PROCEDURE

The Transversus Thoracic Plane Block is a recent regional anesthesia technique. It provides analgesia for the anterior cutaneous branches of the intercostal nerves T2-6 to the medial anterior chest wall via a single injection of local anesthesia between the internal intercostal muscle and the transversus thoracic muscle located between the third and fourth (or fourth and fifth) intercostal space. It is noteworthy that the TTPB can consequently reduce pulmonary morbidity and the need for high-dose opioids.

Interventions

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Transversus Thoracic Plane Block

The Transversus Thoracic Plane Block is a recent regional anesthesia technique. It provides analgesia for the anterior cutaneous branches of the intercostal nerves T2-6 to the medial anterior chest wall via a single injection of local anesthesia between the internal intercostal muscle and the transversus thoracic muscle located between the third and fourth (or fourth and fifth) intercostal space. It is noteworthy that the TTPB can consequently reduce pulmonary morbidity and the need for high-dose opioids.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

\- All patients scheduled for cardiac surgery via sternotomy under cardiopulmonary bypass

Exclusion Criteria

* Previous cardiac surgery
* Urgent surgery
* Pregnant women
* Allergy to local anesthetics
* Opioid dependence
* Low ejection fraction \< 30%
* Presence or onset of cognitive or neurological disorders preventing pain assessment
* Infection at injection sites
* Coagulopathy
* Patients on dual antiplatelet therapy
* Renal insufficiency with Glomerular filtration rate (GFR) \< 30 mL/min
* History of thoracic radiotherapy
* History of mastectomy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Saint-Joseph University

OTHER

Sponsor Role lead

Responsible Party

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Joanna Tohme

Medical Doctor, Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Samia Madi Jebara, MD,PHD

Role: STUDY_DIRECTOR

Saint-Joseph University

Locations

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Hotel Dieu de France

Beirut, , Lebanon

Site Status

Countries

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Lebanon

Central Contacts

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Joanna Tohme, MD

Role: CONTACT

+96170492735

References

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Jeanneteau A, Demarquette A, Blanchard-Daguet A, Fouquet O, Lasocki S, Riou J, Rineau E, Leger M. Effect of superficial and deep parasternal blocks on recovery after cardiac surgery: study protocol for a randomized controlled trial. Trials. 2023 Jul 6;24(1):444. doi: 10.1186/s13063-023-07446-2.

Reference Type BACKGROUND
PMID: 37415221 (View on PubMed)

Wong HMK, Chen PY, Tang GCC, Chiu SLC, Mok LYH, Au SSW, Wong RHL. Deep Parasternal Intercostal Plane Block for Intraoperative Pain Control in Cardiac Surgical Patients for Sternotomy: A Prospective Randomized Controlled Trial. J Cardiothorac Vasc Anesth. 2024 Mar;38(3):683-690. doi: 10.1053/j.jvca.2023.11.038. Epub 2023 Nov 30.

Reference Type BACKGROUND
PMID: 38148266 (View on PubMed)

Fujii S, Bairagi R, Roche M, Zhou JR. Transversus Thoracis Muscle Plane Block. Biomed Res Int. 2019 Jul 7;2019:1716365. doi: 10.1155/2019/1716365. eCollection 2019.

Reference Type BACKGROUND
PMID: 31360703 (View on PubMed)

Other Identifiers

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CEHDF2392

Identifier Type: -

Identifier Source: org_study_id

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