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Erector Spinae Plane Block Versus Paravertebral Block for Analgesia After Cardiac Surgery (PEPS) (PEPS)

Primary Purpose

Pain Syndrome, Analgesia, Anesthesia, Local

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Ultrasound-guided Bilateral Paravertebral Block performed with a 20 ml injection of ropivacapine 3,75 mg/ml/side
Ultrasound-guided Bilateral Erector Spinae plane Block performed with a 20 ml injection ropivacaine 3,75 mg/ml/side
Sponsored by
Institut Mutualiste Montsouris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain Syndrome focused on measuring Cardiac surgery, Regional analgesia, Pain control

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Institut Mutualiste montsourisRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Paravertebral Block

Erector Spinae Plane Block

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Pain assessment
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)

Secondary Outcome Measures

Efficacy of the block (a)
Based on hemodynamic response to incision and sternotomy (increase in heart rate, measured in beats per minute (bpm)
Efficacy of the block (b)
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)
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
Intraoperative sufentanil consumption (at the discretion of physicians based on haemodynamic variations and ANI values). Measured in ng/ml.
Postoperative pain assessment
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)
Postoperative Morphine consumption
Morphine PCA consumption, measured in mg/h.
Side effects associated to morphine
Incidence of post operative nausea, vomiting and sedation
Spirometry parameters.
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
Complication(s) associated to the procedure
Pneumothorax, major hematoma, sympathetic block

Full Information

First Posted
July 22, 2020
Last Updated
March 2, 2022
Sponsor
Institut Mutualiste Montsouris
Collaborators
Fondation Ophtalmologique Adolphe de Rothschild
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1. Study Identification

Unique Protocol Identification Number
NCT04546113
Brief Title
Erector Spinae Plane Block Versus Paravertebral Block for Analgesia After Cardiac Surgery (PEPS)
Acronym
PEPS
Official Title
Erector Spinae Plane Block Versus Paravertebral Block for Analgesic Outcomes After Cardiac Surgery (PEPS): a Prospective Randomized Comparative Study.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 7, 2021 (Actual)
Primary Completion Date
February 4, 2023 (Anticipated)
Study Completion Date
February 4, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Mutualiste Montsouris
Collaborators
Fondation Ophtalmologique Adolphe de Rothschild

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain Syndrome, Analgesia, Anesthesia, Local
Keywords
Cardiac surgery, Regional analgesia, Pain control

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Paravertebral Block
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Erector Spinae Plane Block
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Ultrasound-guided Bilateral Paravertebral Block performed with a 20 ml injection of ropivacapine 3,75 mg/ml/side
Intervention Description
Bilateral injection of 20 ml of Ropivacaïne 3,75 mg/ml/side
Intervention Type
Procedure
Intervention Name(s)
Ultrasound-guided Bilateral Erector Spinae plane Block performed with a 20 ml injection ropivacaine 3,75 mg/ml/side
Intervention Description
Bilateral injection of 20 ml of Ropivacaïne 3,75 mg/ml/side
Primary Outcome Measure Information:
Title
Pain assessment
Description
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)
Time Frame
6 hours from the end of the surgery
Secondary Outcome Measure Information:
Title
Efficacy of the block (a)
Description
Based on hemodynamic response to incision and sternotomy (increase in heart rate, measured in beats per minute (bpm)
Time Frame
During the surgery
Title
Efficacy of the block (b)
Description
Based on variations in the ANI (Anti Nociceptive Index) value (scale from 0 (maximum of nociception) to 100 (complete analgesia))
Time Frame
During the surgery
Title
Efficacy of the block (c)
Description
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.
Time Frame
During the surgery
Title
Intraoperative sufentanil consumption
Description
Intraoperative sufentanil consumption (at the discretion of physicians based on haemodynamic variations and ANI values). Measured in ng/ml.
Time Frame
During the surgery
Title
Postoperative pain assessment
Description
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)
Time Frame
3, 6, 12, 24, 48 hours from the end of the surgery
Title
Postoperative Morphine consumption
Description
Morphine PCA consumption, measured in mg/h.
Time Frame
3, 6, 12, 24, 48 hours from the end of the surgery
Title
Side effects associated to morphine
Description
Incidence of post operative nausea, vomiting and sedation
Time Frame
3, 6, 12, 24, 48 hours from the end of the surgery
Title
Spirometry parameters.
Description
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
Time Frame
24 hours from the end of the surgery
Title
Complication(s) associated to the procedure
Description
Pneumothorax, major hematoma, sympathetic block
Time Frame
48 hours from the end of the surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fehmi KATTOU, MD
Phone
0156616263
Ext
33
Email
fehmi.kattou@imm.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Chahrazad BEY BOUMEZRAG
Phone
0156616983
Ext
33
Email
chahrazad.beyboumezrag@imm.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fehmi KATTOU, MD
Organizational Affiliation
Institut Mutualiste Montsouris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Mutualiste montsouris
City
Paris
ZIP/Postal Code
75014
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chahrazad Bey Boumezrag
Phone
0156616983
Ext
33
Email
chahrazad.beyboumezrag@imm.fr
First Name & Middle Initial & Last Name & Degree
Fehmi Kattou, MD

12. IPD Sharing Statement

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Erector Spinae Plane Block Versus Paravertebral Block for Analgesia After Cardiac Surgery (PEPS)

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