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

NCT ID: NCT04546113

Last Updated: 2025-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-07
• Study Completion Date: 2023-11-02

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.

Conditions

Pain Syndrome; Analgesia; Anesthesia, Local

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Paravertebral Block

If the patient is randomized to group Paravertebral Block, the anesthesiologist performs TPVB after induction of general anesthesia. The patient is positioned in lateral decubitus 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.

Group Type: ACTIVE_COMPARATOR

Ultrasound-guided Bilateral Paravertebral Block performed with a 20 ml injection of Ropivacaine 3,75 mg/ml/side

Intervention Type: PROCEDURE

Bilateral injection of 20 ml of Ropivacaine 3,75 mg/ml/side

Erector Spinae Plane Block

If the patient is randomized to group "Erector Spinae Plane Block", the anesthesiologist performs the ESPb block after 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.

Group Type: EXPERIMENTAL

Ultrasound-guided Bilateral Erector Spinae plane Block performed with a 20 ml injection ropivacaine 3,75 mg/ml/side

Intervention Type: PROCEDURE

Bilateral injection of 20 ml of Ropivacaine 3,75 mg/ml/side

Interventions

Ultrasound-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

Intervention Type: PROCEDURE

Ultrasound-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

Intervention Type: PROCEDURE

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
• 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondation Ophtalmologique Adolphe de Rothschild

NETWORK

Sponsor Role: collaborator

Institut Mutualiste Montsouris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Olivier MONTANDRAU, MD

Role: PRINCIPAL_INVESTIGATOR

Institut Mutualiste Montsouris

Locations

Institut Mutualiste montsouris

Paris, , France

Countries

France

Other Identifiers

ANEST-03-2019

Identifier Type: -

Identifier Source: org_study_id