Analgesia, Anesthesia, Local, Pain Syndrome
Conditions
Keywords
Cardiac surgery, Regional analgesia, Pain control
Brief summary
The purpose of this randomized double-blind study is to compare the analgesic efficacy of the bilateral Erector Spinae Plane (ESP) block versus the bilateral Thoracic Paravertebral block (TPVB), by ultrasound-guided single injection in patients who underwent sternotomy for cardiac surgery.
Detailed description
Cardiac surgery causes moderate to severe postoperative pain during the first 24 - 48 post-operative hours. This pain is greatly increased by mobilization (respiratory physiotherapy) and leads to the consumption of morphine. Appropriate analgesia, along with a reduction in morphine consumption are important factors in reducing morbidity after cardiac surgery and allow better postoperative rehabilitation. Recently, the concept of multimodal analgesia has become established, which corresponds to ensuring optimal analgesia through the use of non-morphine drugs associated with locoregional analgesia. During cardiac surgery, Paravertebral block (TPVB) technique is the first line of reference in our establishment. Lately, a new approach of blocking the intercostal nerves called Erector Spinae Plane block (ESP) has been discovered. It is a technique that seems simpler and safer than TPVB. Until now, the analgesic efficacy of the ESP block compared to TPVB after cardiac surgery by sternotomy has never been studied.
Interventions
PROCEDUREUltrasound-guided Bilateral Paravertebral Block performed with a 20 ml injection of Ropivacaine 3,75 mg/ml/side
Bilateral injection of 20 ml of Ropivacaine 3,75 mg/ml/side
PROCEDUREUltrasound-guided Bilateral Erector Spinae plane Block performed with a 20 ml injection ropivacaine 3,75 mg/ml/side
Bilateral injection of 20 ml of Ropivacaine 3,75 mg/ml/side
Sponsors
Fondation Ophtalmologique Adolphe de Rothschild
Institut Mutualiste Montsouris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Undergoing any (scheduled) surgery of the heart (valve or coronary surgery) via a median sternotomy * Physical status classification (ASA) ≤3 * Patients benefiting from a Social Security scheme or benefiting from it through a third party
Exclusion criteria
* Emergency cardiac surgery *
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain assessment | 6 hours from the end of the surgery | Pain assessment measured with Visual Analogue Scale (VAS) between 0 (no pain, best outcome) and 10 (worst possible pain, worst outcome) at mobility, (respiratory effort during peak flow meter measurement) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of the block (b) | During the surgery | Based on variations in the ANI (Anti Nociceptive Index) value (scale from 0 (maximum of nociception) to 100 (complete analgesia)) |
| Efficacy of the block (c) | During the surgery | Based on hemodynamic response to incision and sternotomy (increase in blood pressure, measured in mmHg). Blood pressure numbers of less than 120/80 mm Hg are considered within the normal range. |
| Intraoperative sufentanil consumption | During the surgery | Intraoperative sufentanil consumption (at the discretion of physicians based on haemodynamic variations and ANI values). Measured in ng/ml. |
| Efficacy of the block (a) | During the surgery | Based on hemodynamic response to incision and sternotomy (increase in heart rate, measured in beats per minute (bpm) |
| Postoperative Morphine consumption | 3, 6, 12, 24, 48 hours from the end of the surgery | Morphine PCA consumption, measured in mg/h. |
| Side effects associated to morphine | 3, 6, 12, 24, 48 hours from the end of the surgery | Incidence of post operative nausea, vomiting and sedation |
| Complication(s) associated to the procedure | 48 hours from the end of the surgery | Pneumothorax, major hematoma, sympathetic block |
| Postoperative pain assessment | 3, 6, 12, 24, 48 hours from the end of the surgery | Pain assessment measured with Visual Analogue Scale between 0 (no pain, best outcome) and 10 (worst possible pain and and worst outcome) at mobility, (respiratory effort during peak flow meter measurement) |
Countries
France
Outcome results
None listed