Clinical trial NCT05160298: Analgesic Effect of Bilateral Erector Spinae Plane Block With Ropivacaine After Sternotomy for Cardiac Surgery
Official title: Analgesic Effect of Bilateral Erector Spinae Plane Block With Ropivacaine After Sternotomy in Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cadiac Surgery
Median Sternotomy
Regional Anesthesia
Postoperative Pain
Keywords: Postoperative analgesia
Erector spinae plane block
Local anesthetics
Ropivacaine
Sternotomy
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2021-12-16
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: * The ropivacaine group (42 patients): Echo-guided bilateral erector spinae block at the arrival in the intensive care unit. 20ml of Ropivacaine 2mg/ml for each side.
* The control group (42 patients): Sham block bilaterally.
Primary purpose: TREATMENT

Brief 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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of pain score during cough
timeFrame: From patient awakening to 48 hours later (one evalution every 4 hours)
Secondary outcomes:
measure: Change of pain score during patient tourn in the bed (lateralization) for nursing
timeFrame: From patient awakening to 48 hours later (one evalution every 4 hours)
measure: Change of pain score during central venous pressure measuring
timeFrame: From patient awakening to 48 hours later (one evalution every 4 hours)
measure: Change of sternal pain score at rest
timeFrame: From patient awakening to 48 hours later (one evalution every 4 hours)
measure: Change of dorsal pain evaluation at rest
timeFrame: From patient awakening to 48 hours later (one evalution every 4 hours)
measure: Opioid consumption
timeFrame: 48 hours after intervention
measure: Satisfaction assessed by the Likert scale
timeFrame: 48 hours after intervention
measure: Spirometry measure of forced vital capacity (FVC)
timeFrame: The day before surgery, the first or second day after surgery and the seventh day after surgery
measure: Spirometry measure of forced expiratory volume in one second (FEV1)
timeFrame: The day before surgery, the first or second day after surgery and the seventh day after surgery
measure: Spirometry measure of FEV1/FVC
timeFrame: The day before surgery, the first or second day after surgery and the seventh day after surgery
measure: Spirometry measure of peak expiratory flow (PEF)
timeFrame: The day before surgery, the first or second day after surgery and the seventh day after surgery
measure: Spirometry measure of force expiratory flow 25% (FEF 25%), FEF 50%, FEF 75%, FEF 25-75%
timeFrame: The day before surgery, the first or second day after surgery and the seventh day after surgery
measure: Diaphragmatic excursion
timeFrame: The day before surgery, the first or second day after surgery and the seventh day after surgery
measure: Diaphragm thickness
timeFrame: The day before surgery, the first or second day after surgery and the seventh day after surgery
measure: Diaphragm thickening fraction
timeFrame: Up to 6 months after surgery (end of Hospital stay)
measure: Digestive function
timeFrame: The day before surgery, the first or second day after surgery and the seventh day after surgery
measure: Digestive function
timeFrame: Up to 6 months after surgery (end of Hospital stay)
measure: Time of drain removal
timeFrame: Up to 6 months after surgery (end of Hospital stay)
measure: Postoperative complications
timeFrame: Up to 1 month after surgery
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Vedat Eljezi
role: PRINCIPAL_INVESTIGATOR
References: