TrialReader


Transversus Thoracic Plane Block for Perioperative Analgesia in Cardiac Surgery

NCT06546722 — Not applicable, Completed, 150 participants, Saint-Joseph University

ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  

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

RegistryNCT06546722
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: double, supportive care
Enrollment150 (Actual)
SponsorSaint-Joseph University (Other)
ConditionsTransversus Thoracic Plane Block, Cardiac Surgery, Post Operative Pain
InterventionsTransversus Thoracic Plane Block (Procedure)
Datesstart 2024-09-01, primary completion 2025-07-01, completion 2025-07-20, first posted 2024-08-09, last updated 2026-07-14
Locations1 site in Lebanon

Related Papers Related Patents Related Grants Related Experts
AI Assistant Save
All trials for Transversus Thoracic Plane Block All trials for Cardiac Surgery All trials of Transversus Thoracic Plane Block

-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. 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?

Expand all sections  ·  Collapse all

+Arms and interventions

ArmTypeInterventionsDescription
PlaceboNo interventionThis group receives standard analgesic treatment and no Transversus Thoracic Plane Block is performed
Transversus Thoracic Plane Block preActive comparatorProcedure: Transversus Thoracic Plane BlockThis group receives standard analgesic treatment and Transversus Thoracic Plane Block is performed before surgery
Transversus Thoracic Plane Block postActive comparatorProcedure: Transversus Thoracic Plane BlockThis group receives standard analgesic treatment and Transversus Thoracic Plane Block is performed at the end of surgery
  • 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.

+Outcome measures

Primary outcomes

  • postoperative pain score [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

  • Perioperative opioid requirement [First 24h postoperatively]: Total dose of opioids required during surgery and 24h postoperatively
  • Time to first opioid administration [First 24h postoperatively]: Time to first opioid administration after surgery
  • Time to extubation [First 24h postoperatively]: Time between arrival to cardiac intensive care unit and extubation
  • Patient satisfaction at 24 hours post surgery [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? "
  • Length of stay at cardiac intensive care unit and hospital stay [3 months postoperatively]: Length of stay at cardiac intensive care unit and hospital stay
  • Incidence of postoperative pneumonia and pneumothorax in cardiac intensive care unit [First 24h postoperatively]: Incidence of postoperative pneumonia and pneumothorax in cardiac intensive care unit

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

FacilityCityCountryStatus
Hotel Dieu de FranceBeirutLebanon

+Publications

  • 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
  • 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
  • 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

+Investigators

My Notes