Analgesic Effect of Bilateral Erector Spinae Plane Block With Ropivacaine After Sternotomy for Cardiac Surgery (ESB-Sterno)

Analgesic Effect of Bilateral Erector Spinae Plane Block With Ropivacaine After Sternotomy in Cardiac Surgery

The sternotomy site is the most painful area after cardiac surgery. Erector spinae plane block is effective in thoracic and abdominal surgery, but literature is lacking in cardiac surgery. The bilateral erector spinae plane block could reduce pain at rest and during mobilization, reduce opioids consumption, decrease postoperative complications, improve respiratory outcomes and improve patient comfort and satisfaction. The research hypothesis is that a single shot bilateral erector spinae plane block could reduce pain during mobilization during the first 48 hours after cardiac surgery performed with sternotomy

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Regional Anesthesia; Median Sternotomy; Cadiac Surgery
• Intervention / Treatment: Drug: Ropivacaine 0,2% Injectable Solution; Other: Control group

Detailed Description

Background:

Pain after cardiac surgery is mostly localized at the sternotomy site. To improve postoperative pain management a number of technics involving loco-regional anesthesia have been developed. The epidural analgesia is the gold standard but the risk of epidural hematoma with heparinization in this surgery avoids its utilization in clinical practice. The paravertebral block can be used equally but there is a risk of pneumothorax. The erector spinae plane block could be a solution as it is a more superficial block. It's efficacity was proven in thoracic and abdominal surgery, but literature is lacking in cardiac surgery. A bilateral erector spinae plane block after cardiac surgery could significantly reduce pain at rest and during mobilization, reduce opioids consumption, decrease postoperative complications, improve respiratory outcomes and improve patient comfort and satisfaction.

The main objective of this to study is to examine the efficacity of a single-shot bilateral erector spinae plane block on pain reduction during mobilization during the first 48 hours after cardiac surgery compared to a control group.

The primary outcome:

Pain scale at patient mobilization during the first postoperative 48 hours measured by numerical pain scale.

Study design:

Prospective, randomized, doubled-blinded, single-center controlled trial with two groups:

1. The ropivacaine group (42 patients): a bilateral erector spinae block will be performed after patient arrival in the intensive care unit before wake up from anesthesia with 20ml of Ropivacaine 2mg/ml bilaterally.
2. The control group (42 patients): a sham block will be performed bilaterally in the same conditions.

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63000
    • CHU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients who undergo scheduled cardiac surgery with sternotomy for aortic or mitral valve replacement either by biological or mechanical prothesis, coronary arterial bypass surgery (CABG).
• Body Mass Index between 18,5 and 33kg/m² (extremity excluded)
• Patients who have given their consent according to the methods described in Title II of the book of the first Public Health Code
• Possession of Social Security insurance

Exclusion Criteria:

• Emergency surgery
• Approach by thoracotomy
• Heart transplant
• Aortic dissection or chirurgical act on ascending thoracic Aorta
• Redo surgery.
• Pregnant women
• Protected minors or adults
• Pre-existing psychiatric pathology including known states of opioid addiction
• Long-term opioid medication (>1month)
• Physical or intellectual inability to use a PCA
• Severe heart failure (ejection fraction less than 40% or PAH > 50 mmHg)
• Preoperative cardiogenic shock
• Severe preoperative chronic or acute renal failure with a creatinine clearance of less than 30 mL / min according to Cockroft's formula
• Known allergy or hypersensitivity to any of the study drugs or analgesia protocol (ropivacaine, paracetamol, opiates).
• Known allergy or hypersensitivity to any of excipients of the study drugs or analgesia protocol
• Refusal of the protocol

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ropivacaine group; Performance of an echo-guided bilateral erector spinae block at the arrival in the intensive care unit with 20ml of Ropivacaine 2mg/ml in each side.	Drug: Ropivacaine 0,2% Injectable Solution; Echo-guided bilateral erector spinae block
Sham Comparator: Control group; Performance of a sham block at the arrival in the intensive care unit with no drugs administration	Other: Control group; Sham block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of pain score during cough	Pain evaluation by a nurse with Numeric Rating Scale (with 0 = no pain; 10= maximum pain) during cough	From patient awakening to 48 hours later (one evalution every 4 hours)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of pain score during patient tourn in the bed (lateralization) for nursing	Pain score evaluation by a nurse with Numeric Rating Scale (with 0 = no pain; 10= maximum pain) during patient lateralization	From patient awakening to 48 hours later (one evalution every 4 hours)
Change of pain score during central venous pressure measuring	Pain score evaluation by a nurse with Numeric Rating Scale (with 0 = no pain; 10= maximum pain) during patient lateralization	From patient awakening to 48 hours later (one evalution every 4 hours)
Change of sternal pain score at rest	Pain score evaluation by a nurse with Numeric Rating Scale (with 0 = no pain; 10= maximum pain) during patient lateralization	From patient awakening to 48 hours later (one evalution every 4 hours)
Change of dorsal pain evaluation at rest	Pain score evaluation by a nurse with Numeric Rating Scale (with 0 = no pain; 10= maximum pain) during patient lateralization	From patient awakening to 48 hours later (one evalution every 4 hours)
Opioid consumption	Total opioid consumption since the awakening of the patient during 48 postoperative hours.	48 hours after intervention
Satisfaction assessed by the Likert scale	Subjective Assessment of pain management by the patient on a Likert scale going from 0 to 4 where 4 is excellent	48 hours after intervention
Spirometry measure of forced vital capacity (FVC)	Assessment of the change of FVC by repeating spirometry during the hospital stay	The day before surgery, the first or second day after surgery and the seventh day after surgery
Spirometry measure of forced expiratory volume in one second (FEV1)	Assessment of the change of FEV1 by repeating spirometry during the hospital stay	The day before surgery, the first or second day after surgery and the seventh day after surgery
Spirometry measure of FEV1/FVC	Assessment of the change of FEV1/FVC by repeating spirometry during the hospital stay	The day before surgery, the first or second day after surgery and the seventh day after surgery
Spirometry measure of peak expiratory flow (PEF)	Assessment of the change of PEF by repeating spirometry during the hospital stay	The day before surgery, the first or second day after surgery and the seventh day after surgery
Spirometry measure of force expiratory flow 25% (FEF 25%), FEF 50%, FEF 75%, FEF 25-75%	Assessment of the change of FEF 25%, FEF 50%, FEF 75%, FEF 25-75% by repeating spirometry during the hospital stay	The day before surgery, the first or second day after surgery and the seventh day after surgery
Diaphragmatic excursion	Assessment of the diaphragmatic excursion by repeating diaphragm echography during the hospital stay	The day before surgery, the first or second day after surgery and the seventh day after surgery
Diaphragm thickness	Assessment of the diaphragmatic thickness by repeating diaphragm echography during the hospital stay	The day before surgery, the first or second day after surgery and the seventh day after surgery
Diaphragm thickening fraction	Assessment of the diaphragmatic thickening fraction (%) by repeating diaphragm echography during the hospital stay	Up to 6 months after surgery (end of Hospital stay)
Digestive function	Time of recovery of normal bowel function. Beginning of oral feeding	The day before surgery, the first or second day after surgery and the seventh day after surgery
Digestive function	Time of recovery of normal bowel function.. Incidence of postoperative nausea and vomiting	Up to 6 months after surgery (end of Hospital stay)
Time of drain removal	Time when the drain are removed of the patient Time when the drain are removed of the patient	Up to 6 months after surgery (end of Hospital stay)
Postoperative complications	occurrence of postoperative respiratory, cardiac, renal, neurological, and infectious complications	Up to 1 month after surgery

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Investigators: Principal Investigator: Vedat Eljezi, University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2021
• Primary Completion (Actual): November 20, 2022
• Study Completion (Actual): December 20, 2022

Study Registration Dates

• First Submitted: October 18, 2021
• First Submitted That Met QC Criteria: December 2, 2021
• First Posted (Actual): December 16, 2021

Study Record Updates

• Last Update Posted (Actual): July 6, 2023
• Last Update Submitted That Met QC Criteria: July 4, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Ropivacaine; Erector spinae plane block; Postoperative analgesia; Sternotomy; Local anesthetics
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: ESB-Sterno (RBHP2021ELJEZI)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No