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

NCT04546113 | Completed

• 1 other identifier: ANEST-03-2019
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain Syndrome; Analgesia; Anesthesia, Local

Keywords

Cardiac surgery; Regional analgesia; Pain control

Outcome Measures

Primary Outcomes (1)

• 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 measurement)

  6 hours from the end of the surgery

Secondary Outcomes (8)

• Efficacy of the block (a)

  During the surgery

• Efficacy of the block (b)

  During the surgery

• Efficacy of the block (c)

  During the surgery

• Intraoperative sufentanil consumption

  During the surgery

• Postoperative pain assessment

  3, 6, 12, 24, 48 hours from the end of the surgery

Study Arms (2)

Paravertebral Block

ACTIVE COMPARATOR

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.

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

Erector Spinae Plane Block

EXPERIMENTAL

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.

Procedure: Ultrasound-guided Bilateral Erector Spinae plane Block performed with a 20 ml injection 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 PROCEDURE

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

Paravertebral Block

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

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

Erector Spinae Plane Block

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Institut Mutualiste Montsouris: lead
• Fondation Ophtalmologique Adolphe de Rothschild: collaborator

Study Sites (1)

Institut Mutualiste montsouris

Paris, 75014, France

Location

Related Publications (1)

• Montandrau O, Kattou F, Arana H, Rekik M, Ait Hamou N, Weisslinger SJ, Teil E, Mekaouar S, Bargaoui A, Bouattour K, Bey Boumezrag C, Lacombe JM, Lebatard N, Zannis K, Beaussier M. Ultrasound-guided thoracic paravertebral block versus erector spinae plane block analgesia for cardiac surgery with median sternotomy: a noninferiority randomised controlled trial. Br J Anaesth. 2026 Feb;136(2):687-694. doi: 10.1016/j.bja.2025.10.039. Epub 2025 Nov 24.

  PMID: 41290467 DERIVED

MeSH Terms

Conditions

Somatoform Disorders; Agnosia

Condition Hierarchy (Ancestors)

Mental Disorders; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Olivier MONTANDRAU, MD

  Institut Mutualiste Montsouris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2020
• First Posted: September 11, 2020
• Study Start: January 7, 2021
• Primary Completion: November 2, 2023
• Study Completion: November 2, 2023
• Last Updated: March 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)