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

Analgesia Clinical Trial

— PEPS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04546113
• Other study ID #: ANEST-03-2019
• Status: Recruiting
• Phase: N/A
• Start date: January 7, 2021
• Est. completion date: February 4, 2023

Study information

• Verified date: March 2022
• Source: Institut Mutualiste Montsouris
• Contact: Fehmi KATTOU, MD
• Phone: 0156616263
• Email: fehmi.kattou[@]imm.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: February 4, 2023
• Est. primary completion date: February 4, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Analgesia
• Anesthesia, Local
• Pain Syndrome

Intervention

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

Locations

Country	Name	City	State
France	Institut Mutualiste montsouris	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Institut Mutualiste Montsouris	Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	6 hours from the end of the surgery
Secondary	Efficacy of the block (a)	Based on hemodynamic response to incision and sternotomy (increase in heart rate, measured in beats per minute (bpm)	During the surgery
Secondary	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))	During the surgery
Secondary	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.	During the surgery
Secondary	Intraoperative sufentanil consumption	Intraoperative sufentanil consumption (at the discretion of physicians based on haemodynamic variations and ANI values). Measured in ng/ml.	During the surgery
Secondary	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)	3, 6, 12, 24, 48 hours from the end of the surgery
Secondary	Postoperative Morphine consumption	Morphine PCA consumption, measured in mg/h.	3, 6, 12, 24, 48 hours from the end of the surgery
Secondary	Side effects associated to morphine	Incidence of post operative nausea, vomiting and sedation	3, 6, 12, 24, 48 hours from the end of the surgery
Secondary	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	24 hours from the end of the surgery
Secondary	Complication(s) associated to the procedure	Pneumothorax, major hematoma, sympathetic block	48 hours from the end of the surgery