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

Postoperative Pain Clinical Trial

— ESB-Sterno  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05160298
• Other study ID #: ESB-Sterno (RBHP2021ELJEZI)
• Status: Completed
• Phase: Phase 2
• Start date: October 20, 2021
• Est. completion date: December 20, 2022

Study information

• Verified date: July 2023
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: December 20, 2022
• Est. primary completion date: November 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 78 Years

Eligibility

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

Related Conditions & MeSH terms

• Median Sternotomy
• Pain, Postoperative
• Postoperative Pain
• Regional Anesthesia

Intervention

Drug:
• Ropivacaine 0,2% Injectable Solution
Echo-guided bilateral erector spinae block

Other:
• Control group
Sham block

Locations

Country	Name	City	State
France	CHU	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Opioid consumption	Total opioid consumption since the awakening of the patient during 48 postoperative hours.	48 hours after intervention
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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)
Secondary	Postoperative complications	occurrence of postoperative respiratory, cardiac, renal, neurological, and infectious complications	Up to 1 month after surgery