- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04546113
Erector Spinae Plane Block Versus Paravertebral Block for Analgesia After Cardiac Surgery (PEPS) (PEPS)
Erector Spinae Plane Block Versus Paravertebral Block for Analgesic Outcomes After Cardiac Surgery (PEPS): a Prospective Randomized Comparative Study.
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Fehmi KATTOU, MD
- Phone Number: 33 0156616263
- Email: fehmi.kattou@imm.fr
Study Contact Backup
- Name: Chahrazad Bey Boumezrag
- Phone Number: 33 0156616983
- Email: chahrazad.beyboumezrag@imm.fr
Study Locations
-
-
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Paris, France, 75014
- Recruiting
- Institut Mutualiste Montsouris
-
Contact:
- Chahrazad Bey Boumezrag
- Phone Number: 33 0156616983
- Email: chahrazad.beyboumezrag@imm.fr
-
Principal Investigator:
- Fehmi Kattou, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
- 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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Paravertebral Block
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.
|
Bilateral injection of 20 ml of Ropivacaïne 3,75 mg/ml/side
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Experimental: Erector Spinae Plane Block
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. |
Bilateral injection of 20 ml of Ropivacaïne 3,75 mg/ml/side
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain assessment
Time Frame: 6 hours from the end of the surgery
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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 measurment)
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6 hours from the end of the surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy of the block (a)
Time Frame: During the surgery
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Based on hemodynamic response to incision and sternotomy (increase in heart rate, measured in beats per minute (bpm)
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During the surgery
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Efficacy of the block (b)
Time Frame: During the surgery
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Based on variations in the ANI (Anti Nociceptive Index) value (scale from 0 (maximum of nociception) to 100 (complete analgesia))
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During the surgery
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Efficacy of the block (c)
Time Frame: During the surgery
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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.
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During the surgery
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Intraoperative sufentanil consumption
Time Frame: During the surgery
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Intraoperative sufentanil consumption (at the discretion of physicians based on haemodynamic variations and ANI values).
Measured in ng/ml.
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During the surgery
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Postoperative pain assessment
Time Frame: 3, 6, 12, 24, 48 hours from the end of the surgery
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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 measurment)
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3, 6, 12, 24, 48 hours from the end of the surgery
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Postoperative Morphine consumption
Time Frame: 3, 6, 12, 24, 48 hours from the end of the surgery
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Morphine PCA consumption, measured in mg/h.
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3, 6, 12, 24, 48 hours from the end of the surgery
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Side effects associated to morphine
Time Frame: 3, 6, 12, 24, 48 hours from the end of the surgery
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Incidence of post operative nausea, vomiting and sedation
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3, 6, 12, 24, 48 hours from the end of the surgery
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Spirometry parameters.
Time Frame: 24 hours from the end of the surgery
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Spirometry measures two key factors: expiratory forced vital capacity (FVC) and forced expiratory volume in one second (FEV1).
We will look at these as a combined number known as the FEV1/FVC ratio.The higher the percentage derived from your FEV1/FVC ratio, in the absence of restrictive lung disease that causes a normal or elevated FEV1/FVC ratio, the healthier your lungs are.
A low ratio suggests that something is blocking your airways
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24 hours from the end of the surgery
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Complication(s) associated to the procedure
Time Frame: 48 hours from the end of the surgery
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Pneumothorax, major hematoma, sympathetic block
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48 hours from the end of the surgery
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Fehmi KATTOU, MD, Institut Mutualiste Montsouris
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ANEST-03-2019
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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