Transversus Thoracic Plane Block for Perioperative Analgesia in Cardiac Surgery

NCT06546722 | Not Yet Recruiting

• 1 other identifier: CEHDF2392
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Transversus Thoracic Plane Block; Cardiac Surgery; Post Operative Pain

Outcome Measures

Primary Outcomes (1)

• postoperative pain score

  The primary outcome is Postoperative Pain Score: Numeric rating scale (NRS) ratings will be assessed at T1 (= upon patient awakening), T2 (= 12 hours postoperatively), T3 (= 24 hours postoperatively) as well as during various painful moments (coughing, drain removal, mobilization). Numeric rating scale (NRS) is a unidimensional measure of pain intensity. It consists of the patient evaluating his pain out of a series of numbers ranging from 0 to 10, where the 2 respective endpoints are "0 = no pain" and "10 = worst possible pain."

  First 24h postoperatively

Secondary Outcomes (6)

• Perioperative opioid requirement

  First 24h postoperatively

• Time to first opioid administration

  First 24h postoperatively

• Time to extubation

  First 24h postoperatively

• Patient satisfaction at 24 hours post surgery

  First 24h postoperatively

• Length of stay at cardiac intensive care unit and hospital stay

  3 months postoperatively

Study Arms (3)

Placebo

NO INTERVENTION

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

Transversus Thoracic Plane Block pre

ACTIVE COMPARATOR

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

Procedure: Transversus Thoracic Plane Block

Transversus Thoracic Plane Block post

ACTIVE COMPARATOR

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

Procedure: Transversus Thoracic Plane Block

Interventions

Transversus Thoracic Plane Block 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; Transversus Thoracic Plane Block pre

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Saint-Joseph University: lead

Study Sites (1)

Hotel Dieu de France

Beirut, 166830, Lebanon

Location

Related Publications (3)

• 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.

  PMID: 37415221 BACKGROUND

• 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.

  PMID: 38148266 BACKGROUND

• 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.

  PMID: 31360703 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Samia Madi Jebara, MD,PHD

  Saint-Joseph University

  STUDY DIRECTOR

Central Study Contacts

Joanna Tohme, MD

CONTACT

+96170492735; joanna-tohme@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Principal investigator

Study Record Dates

• First Submitted: August 4, 2024
• First Posted: August 9, 2024
• Study Start: September 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: December 30, 2025
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

LE (1)