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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
- All patients scheduled for cardiac surgery via sternotomy under cardiopulmonary bypass
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joanna Tohme, MD | Contact | +96170492735 | joanna-tohme@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Samia Madi Jebara, MD,PHD | Saint-Joseph University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hotel Dieu de France | Beirut | 166830 | Lebanon |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37415221 | Background | 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. | |
| 38148266 | Background |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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|
| 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 |
| 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. |
| 31360703 | 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. |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |