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Completed

NCT Number: NCT04546113

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut Mutualiste montsouris

Paris, 75014, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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

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

Primary outcomes

  1. 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 measurement)

Secondary outcomes

  1. 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)

  2. 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))

  3. 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.

  4. 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.

  5. 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 measurement)

  6. Postoperative Morphine consumption

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

    Morphine PCA consumption, measured in mg/h.

  7. 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

  8. Complication(s) associated to the procedure

    Time frame: 48 hours from the end of the surgery

    Pneumothorax, major hematoma, sympathetic block

Sponsors and collaborators

Lead sponsor

Institut Mutualiste Montsouris

Other

Collaborators

  • Fondation Ophtalmologique Adolphe de Rothschild

Registry information

Official study title

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

Acronym: PEPS

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Sep 11, 2020
Registry last updated
Mar 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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