Clinical trial NCT06546722: Transversus Thoracic Plane Block for Perioperative Analgesia in Cardiac Surgery
Official title: Transversus Thoracic Plane Block for Perioperative Analgesia in Cardiac Surgery: a Randomized Controlled Prospective Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Transversus Thoracic Plane Block
Cardiac Surgery
Post Operative Pain
Lead sponsor: Saint-Joseph University
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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. 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?


Eligibility criteria: 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

Primary outcomes:
measure: postoperative pain score
timeFrame: First 24h postoperatively
Secondary outcomes:
measure: Perioperative opioid requirement
timeFrame: First 24h postoperatively
measure: Time to first opioid administration
timeFrame: First 24h postoperatively
measure: Time to extubation
timeFrame: First 24h postoperatively
measure: Patient satisfaction at 24 hours post surgery
timeFrame: First 24h postoperatively
measure: Length of stay at cardiac intensive care unit and hospital stay
timeFrame: 3 months postoperatively
measure: Incidence of postoperative pneumonia and pneumothorax in cardiac intensive care unit
timeFrame: First 24h postoperatively
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: Hotel Dieu de France
Study officials:
affiliation: Saint-Joseph University
name: Samia Madi Jebara, MD,PHD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.