Erector Spinae Plane Block Versus Paravertebral Block for Analgesia After Cardiac Surgery (PEPS)
- Conditions
- Pain SyndromeAnalgesiaAnesthesia, Local
- Interventions
- Procedure: Ultrasound-guided Bilateral Paravertebral Block performed with a 20 ml injection of ropivacapine 3,75 mg/ml/sideProcedure: Ultrasound-guided Bilateral Erector Spinae plane Block performed with a 20 ml injection ropivacaine 3,75 mg/ml/side
- Registration Number
- NCT04546113
- Lead Sponsor
- Institut Mutualiste Montsouris
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 96
- 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
- Emergency cardiac surgery
- Exclusion criteria related to cardiac surgery with thoracotomy, occurrence of aortic dissection, redo surgery.
- Aortic counterpulsation
- Preoperative cardiogenic shock
- LVEF< 30%
- Severe preoperative chronic or acute renal failure with creatinine clearance less than 30 mL / min according to the MDRD formula
- Pre-existing psychiatric pathology, including addiction to opioids
- Physical or intellectual incapacity to use a PCA
- Known allergy or hypersensitivity to any of the study drugs or analgesia protocol (ropivacaine, paracetamol, opioids)
- Contraindication for performing the paravertebral block and Erector of the spine (ESP): Infection at the site of injection, severe hemostasis disorder, thoracic spinal pathology making the procedure difficult or dangerous to operate
- Obese patient (BMI> 30kg / m2) with poorly perceived thoracic spinous processes.
- vulnerable patients(Pregnant or breastfeeding women, persons benefiting from enhanced protection, namely persons deprived of their liberty by a judicial or administrative decision, adults under legal protection).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Paravertebral Block Ultrasound-guided Bilateral Paravertebral Block performed with a 20 ml injection of ropivacapine 3,75 mg/ml/side If the patient is randomized to group Paravertebral Block, the anesthesiologist performs TPVB before induction of general anesthesia. The patient is positioned in lateral décubitus position. The anesthetist performs the bilateral paravertebral block with ultrasound identification of the paravertebral space at the T4-T5 level. Slow injection of 0.3 to 0.35 ml / kg of ropivacaine on each side (diluted to 3.75 mg / ml = dilution in a 20 ml syringe with 10 ml of ropivacaine 7.5 mg / ml and 10 ml of NaCl 0.9%) after aspiration test. Erector Spinae Plane Block Ultrasound-guided Bilateral Erector Spinae plane Block performed with a 20 ml injection ropivacaine 3,75 mg/ml/side If the patient is randomized to group "Erector Spinae Plane Block", the anesthesiologist performs the ESPb block before induction of general anesthesia. The patient is positioned in a right lateral decubitus position. The anesthesiologist performs the erector block of the spine ESP with ultrasound identification at the T4-T5 level (identify the 1st rib on ultrasound then the space T4 to T5). Slow injection of 20 ml of ropivacaine on each side (diluted to 3.75 mg / ml = dilution in a 20 ml syringe with 10 ml of ropivacaine 7.5 mg / ml and 10 ml of 0.9% NaCl) after aspiration test. The patient is then turned in left lateral decubitus position and the contralateral block is performed according to the same procedure.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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)
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.
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)
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
Trial Locations
- Locations (1)
Institut Mutualiste montsouris
🇫🇷Paris, France