Cardiac Surgery, Post Operative Pain, Transversus Thoracic Plane Block
Conditions
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?
Interventions
PROCEDURETransversus 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.
Sponsors
Saint-Joseph University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Lebanon
Contacts
STUDY_DIRECTORSamia Madi Jebara, MD,PHD
Saint-Joseph University
Outcome results
None listed