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Completed

NCT Number: NCT06546722

Transversus Thoracic Plane Block for Perioperative Analgesia in Cardiac Surgery

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?

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Key information

Conditions

Transversus Thoracic Plane Block Cardiac Surgery Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Post Operative Pain Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hotel Dieu de France

Beirut, 166830, Lebanon

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

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.

Primary outcomes

  1. postoperative pain score

    Time frame: First 24h postoperatively

    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."

Secondary outcomes

  1. Perioperative opioid requirement

    Time frame: First 24h postoperatively

    Total dose of opioids required during surgery and 24h postoperatively

  2. Time to first opioid administration

    Time frame: First 24h postoperatively

    Time to first opioid administration after surgery

  3. Time to extubation

    Time frame: First 24h postoperatively

    Time between arrival to cardiac intensive care unit and extubation

  4. Patient satisfaction at 24 hours post surgery

    Time frame: First 24h postoperatively

    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? "

  5. Length of stay at cardiac intensive care unit and hospital stay

    Time frame: 3 months postoperatively

    Length of stay at cardiac intensive care unit and hospital stay

  6. Incidence of postoperative pneumonia and pneumothorax in cardiac intensive care unit

    Time frame: First 24h postoperatively

    Incidence of postoperative pneumonia and pneumothorax in cardiac intensive care unit

Sponsors and collaborators

Lead sponsor

Saint-Joseph University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 9, 2024
Registry last updated
Jul 14, 2026

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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