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Completed

NCT Number: NCT05160298

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

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Key information

Age range

18 year–78 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CHU

Clermont-Ferrand, 63000, France

About this study

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:

  • 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.
  • The control group (42 patients): a sham block will be performed bilaterally in the same conditions.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Ropivacaine 0,2% Injectable Solution

Drug

Echo-guided bilateral erector spinae block

Control Group

Other

Sham block

Primary outcomes

  1. Change of pain score during cough

    Time frame: From patient awakening to 48 hours later (one evalution every 4 hours)

    Pain evaluation by a nurse with Numeric Rating Scale (with 0 = no pain; 10= maximum pain) during cough

Secondary outcomes

  1. Change of pain score during patient tourn in the bed (lateralization) for nursing

    Time frame: From patient awakening to 48 hours later (one evalution every 4 hours)

    Pain score evaluation by a nurse with Numeric Rating Scale (with 0 = no pain; 10= maximum pain) during patient lateralization

  2. Change of pain score during central venous pressure measuring

    Time frame: From patient awakening to 48 hours later (one evalution every 4 hours)

    Pain score evaluation by a nurse with Numeric Rating Scale (with 0 = no pain; 10= maximum pain) during patient lateralization

  3. Change of sternal pain score at rest

    Time frame: From patient awakening to 48 hours later (one evalution every 4 hours)

    Pain score evaluation by a nurse with Numeric Rating Scale (with 0 = no pain; 10= maximum pain) during patient lateralization

  4. Change of dorsal pain evaluation at rest

    Time frame: From patient awakening to 48 hours later (one evalution every 4 hours)

    Pain score evaluation by a nurse with Numeric Rating Scale (with 0 = no pain; 10= maximum pain) during patient lateralization

  5. Opioid consumption

    Time frame: 48 hours after intervention

    Total opioid consumption since the awakening of the patient during 48 postoperative hours.

  6. Satisfaction assessed by the Likert scale

    Time frame: 48 hours after intervention

    Subjective Assessment of pain management by the patient on a Likert scale going from 0 to 4 where 4 is excellent

  7. Spirometry measure of forced vital capacity (FVC)

    Time frame: The day before surgery, the first or second day after surgery and the seventh day after surgery

    Assessment of the change of FVC by repeating spirometry during the hospital stay

  8. Spirometry measure of forced expiratory volume in one second (FEV1)

    Time frame: The day before surgery, the first or second day after surgery and the seventh day after surgery

    Assessment of the change of FEV1 by repeating spirometry during the hospital stay

  9. Spirometry measure of FEV1/FVC

    Time frame: The day before surgery, the first or second day after surgery and the seventh day after surgery

    Assessment of the change of FEV1/FVC by repeating spirometry during the hospital stay

  10. Spirometry measure of peak expiratory flow (PEF)

    Time frame: The day before surgery, the first or second day after surgery and the seventh day after surgery

    Assessment of the change of PEF by repeating spirometry during the hospital stay

  11. Spirometry measure of force expiratory flow 25% (FEF 25%), FEF 50%, FEF 75%, FEF 25-75%

    Time frame: The day before surgery, the first or second day after surgery and the seventh day after surgery

    Assessment of the change of FEF 25%, FEF 50%, FEF 75%, FEF 25-75% by repeating spirometry during the hospital stay

  12. Diaphragmatic excursion

    Time frame: The day before surgery, the first or second day after surgery and the seventh day after surgery

    Assessment of the diaphragmatic excursion by repeating diaphragm echography during the hospital stay

  13. Diaphragm thickness

    Time frame: The day before surgery, the first or second day after surgery and the seventh day after surgery

    Assessment of the diaphragmatic thickness by repeating diaphragm echography during the hospital stay

  14. Diaphragm thickening fraction

    Time frame: Up to 6 months after surgery (end of Hospital stay)

    Assessment of the diaphragmatic thickening fraction (%) by repeating diaphragm echography during the hospital stay

  15. Digestive function

    Time frame: The day before surgery, the first or second day after surgery and the seventh day after surgery

    Time of recovery of normal bowel function. Beginning of oral feeding

  16. Digestive function

    Time frame: Up to 6 months after surgery (end of Hospital stay)

    Time of recovery of normal bowel function.. Incidence of postoperative nausea and vomiting

  17. Time of drain removal

    Time frame: Up to 6 months after surgery (end of Hospital stay)

    Time when the drain are removed of the patient

    Time when the drain are removed of the patient

  18. Postoperative complications

    Time frame: Up to 1 month after surgery

    occurrence of postoperative respiratory, cardiac, renal, neurological, and infectious complications

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Official study title

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

Acronym: ESB-Sterno

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 16, 2021
Registry last updated
Jul 6, 2023

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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