Transversus Thoracic Plane Block for Perioperative Analgesia in Cardiac Surgery

Transversus Thoracic Plane Block for Perioperative Analgesia in Cardiac Surgery: a Randomized Controlled Prospective Study

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?

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiac Surgery; Post Operative Pain; Transversus Thoracic Plane Block
• Intervention / Treatment: Procedure: Transversus Thoracic Plane Block

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joanna Tohme, MD; Phone Number: +96170492735; Email: joanna-tohme@hotmail.com

Study Locations

• Lebanon
  • Beirut, Lebanon, 166830
    • Hotel Dieu de France

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Placebo; This group receives standard analgesic treatment and no Transversus Thoracic Plane Block is performed
Active Comparator: Transversus Thoracic Plane Block pre; This group receives standard analgesic treatment and Transversus Thoracic Plane Block is performed before surgery	Procedure: 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.
Active Comparator: Transversus Thoracic Plane Block post; This group receives standard analgesic treatment and Transversus Thoracic Plane Block is performed at the end of surgery	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perioperative opioid requirement	Total dose of opioids required during surgery and 24h postoperatively	First 24h postoperatively
Time to first opioid administration	Time to first opioid administration after surgery	First 24h postoperatively
Time to extubation	Time between arrival to cardiac intensive care unit and extubation	First 24h postoperatively
Patient satisfaction at 24 hours post surgery	Patient satisfaction is measured by asking patients one question at 24 hours post surgery: "On a scale from 0 to 10, 0 = not satisfied at all, 10 = extremely satisfied, how satisfied do you feel concerning pain management during the first 24 hours after surgery? "	First 24h postoperatively
Length of stay at cardiac intensive care unit and hospital stay	Length of stay at cardiac intensive care unit and hospital stay	3 months postoperatively
Incidence of postoperative pneumonia and pneumothorax in cardiac intensive care unit	Incidence of postoperative pneumonia and pneumothorax in cardiac intensive care unit	First 24h postoperatively

Collaborators and Investigators

• Sponsor: Saint-Joseph University
• Investigators: Study Director: Samia Madi Jebara, MD,PHD, Saint-Joseph University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: August 4, 2024
• First Submitted That Met QC Criteria: August 7, 2024
• First Posted (Actual): August 9, 2024

Study Record Updates

• Last Update Posted (Actual): August 9, 2024
• Last Update Submitted That Met QC Criteria: August 7, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: CEHDF2392

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No