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

March 2, 2022 updated by: Institut Mutualiste Montsouris

Erector Spinae Plane Block Versus Paravertebral Block for Analgesic Outcomes After Cardiac Surgery (PEPS): a Prospective Randomized Comparative Study.

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.

Study Overview

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

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Paris, France, 75014
        • Recruiting
        • Institut Mutualiste Montsouris
        • Contact:
        • Principal Investigator:
          • Fehmi Kattou, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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

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
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)
6 hours from the end of the surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of the block (a)
Time Frame: During the surgery
Based on hemodynamic response to incision and sternotomy (increase in heart rate, measured in beats per minute (bpm)
During the surgery
Efficacy of the block (b)
Time Frame: During the surgery
Based on variations in the ANI (Anti Nociceptive Index) value (scale from 0 (maximum of nociception) to 100 (complete analgesia))
During the surgery
Efficacy of the block (c)
Time Frame: 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.
During the surgery
Intraoperative sufentanil consumption
Time Frame: During the surgery
Intraoperative sufentanil consumption (at the discretion of physicians based on haemodynamic variations and ANI values). Measured in ng/ml.
During the surgery
Postoperative pain assessment
Time Frame: 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 measurment)
3, 6, 12, 24, 48 hours from the end of the surgery
Postoperative Morphine consumption
Time Frame: 3, 6, 12, 24, 48 hours from the end of the surgery
Morphine PCA consumption, measured in mg/h.
3, 6, 12, 24, 48 hours from the end of the surgery
Side effects associated to morphine
Time Frame: 3, 6, 12, 24, 48 hours from the end of the surgery
Incidence of post operative nausea, vomiting and sedation
3, 6, 12, 24, 48 hours from the end of the surgery
Spirometry parameters.
Time Frame: 24 hours from the end of the surgery
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
24 hours from the end of the surgery
Complication(s) associated to the procedure
Time Frame: 48 hours from the end of the surgery
Pneumothorax, major hematoma, sympathetic block
48 hours from the end of the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Fehmi KATTOU, MD, Institut Mutualiste Montsouris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 7, 2021

Primary Completion (Anticipated)

February 4, 2023

Study Completion (Anticipated)

February 4, 2023

Study Registration Dates

First Submitted

July 22, 2020

First Submitted That Met QC Criteria

September 4, 2020

First Posted (Actual)

September 11, 2020

Study Record Updates

Last Update Posted (Actual)

March 3, 2022

Last Update Submitted That Met QC Criteria

March 2, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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