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

Primary Purpose

Cadiac Surgery, Median Sternotomy, Regional Anesthesia

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Ropivacaine 0,2% Injectable Solution
Control group
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cadiac Surgery focused on measuring Postoperative analgesia, Erector spinae plane block, Local anesthetics, Ropivacaine, Sternotomy

Eligibility Criteria

18 Years - 78 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Ropivacaine group

Control group

Arm Description

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.

Performance of a sham block at the arrival in the intensive care unit with no drugs administration

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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
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
Opioid consumption
Total opioid consumption since the awakening of the patient during 48 postoperative hours.
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
Spirometry measure of forced vital capacity (FVC)
Assessment of the change of FVC by repeating spirometry during the hospital stay
Spirometry measure of forced expiratory volume in one second (FEV1)
Assessment of the change of FEV1 by repeating spirometry during the hospital stay
Spirometry measure of FEV1/FVC
Assessment of the change of FEV1/FVC by repeating spirometry during the hospital stay
Spirometry measure of peak expiratory flow (PEF)
Assessment of the change of PEF by repeating spirometry during the hospital stay
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
Diaphragmatic excursion
Assessment of the diaphragmatic excursion by repeating diaphragm echography during the hospital stay
Diaphragm thickness
Assessment of the diaphragmatic thickness by repeating diaphragm echography during the hospital stay
Diaphragm thickening fraction
Assessment of the diaphragmatic thickening fraction (%) by repeating diaphragm echography during the hospital stay
Digestive function
Time of recovery of normal bowel function. Beginning of oral feeding
Digestive function
Time of recovery of normal bowel function.. Incidence of postoperative nausea and vomiting
Time of drain removal
Time when the drain are removed of the patient Time when the drain are removed of the patient
Postoperative complications
occurrence of postoperative respiratory, cardiac, renal, neurological, and infectious complications

Full Information

First Posted
October 18, 2021
Last Updated
July 4, 2023
Sponsor
University Hospital, Clermont-Ferrand
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1. Study Identification

Unique Protocol Identification Number
NCT05160298
Brief Title
Analgesic Effect of Bilateral Erector Spinae Plane Block With Ropivacaine After Sternotomy for Cardiac Surgery
Acronym
ESB-Sterno
Official Title
Analgesic Effect of Bilateral Erector Spinae Plane Block With Ropivacaine After Sternotomy in Cardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
October 20, 2021 (Actual)
Primary Completion Date
November 20, 2022 (Actual)
Study Completion Date
December 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cadiac Surgery, Median Sternotomy, Regional Anesthesia, Postoperative Pain
Keywords
Postoperative analgesia, Erector spinae plane block, Local anesthetics, Ropivacaine, Sternotomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
The patient will be under sedation during the block performance. Th nurse in charge to the patient will be absent during the block performance and the block will be realized by the practitioner who will not take care of the patient during his hospitalization
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ropivacaine group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
Performance of a sham block at the arrival in the intensive care unit with no drugs administration
Intervention Type
Drug
Intervention Name(s)
Ropivacaine 0,2% Injectable Solution
Intervention Description
Echo-guided bilateral erector spinae block
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
Sham block
Primary Outcome Measure Information:
Title
Change of pain score during cough
Description
Pain evaluation by a nurse with Numeric Rating Scale (with 0 = no pain; 10= maximum pain) during cough
Time Frame
From patient awakening to 48 hours later (one evalution every 4 hours)
Secondary Outcome Measure Information:
Title
Change of pain score during patient tourn in the bed (lateralization) for nursing
Description
Pain score evaluation by a nurse with Numeric Rating Scale (with 0 = no pain; 10= maximum pain) during patient lateralization
Time Frame
From patient awakening to 48 hours later (one evalution every 4 hours)
Title
Change of pain score during central venous pressure measuring
Description
Pain score evaluation by a nurse with Numeric Rating Scale (with 0 = no pain; 10= maximum pain) during patient lateralization
Time Frame
From patient awakening to 48 hours later (one evalution every 4 hours)
Title
Change of sternal pain score at rest
Description
Pain score evaluation by a nurse with Numeric Rating Scale (with 0 = no pain; 10= maximum pain) during patient lateralization
Time Frame
From patient awakening to 48 hours later (one evalution every 4 hours)
Title
Change of dorsal pain evaluation at rest
Description
Pain score evaluation by a nurse with Numeric Rating Scale (with 0 = no pain; 10= maximum pain) during patient lateralization
Time Frame
From patient awakening to 48 hours later (one evalution every 4 hours)
Title
Opioid consumption
Description
Total opioid consumption since the awakening of the patient during 48 postoperative hours.
Time Frame
48 hours after intervention
Title
Satisfaction assessed by the Likert scale
Description
Subjective Assessment of pain management by the patient on a Likert scale going from 0 to 4 where 4 is excellent
Time Frame
48 hours after intervention
Title
Spirometry measure of forced vital capacity (FVC)
Description
Assessment of the change of FVC by repeating spirometry during the hospital stay
Time Frame
The day before surgery, the first or second day after surgery and the seventh day after surgery
Title
Spirometry measure of forced expiratory volume in one second (FEV1)
Description
Assessment of the change of FEV1 by repeating spirometry during the hospital stay
Time Frame
The day before surgery, the first or second day after surgery and the seventh day after surgery
Title
Spirometry measure of FEV1/FVC
Description
Assessment of the change of FEV1/FVC by repeating spirometry during the hospital stay
Time Frame
The day before surgery, the first or second day after surgery and the seventh day after surgery
Title
Spirometry measure of peak expiratory flow (PEF)
Description
Assessment of the change of PEF by repeating spirometry during the hospital stay
Time Frame
The day before surgery, the first or second day after surgery and the seventh day after surgery
Title
Spirometry measure of force expiratory flow 25% (FEF 25%), FEF 50%, FEF 75%, FEF 25-75%
Description
Assessment of the change of FEF 25%, FEF 50%, FEF 75%, FEF 25-75% by repeating spirometry during the hospital stay
Time Frame
The day before surgery, the first or second day after surgery and the seventh day after surgery
Title
Diaphragmatic excursion
Description
Assessment of the diaphragmatic excursion by repeating diaphragm echography during the hospital stay
Time Frame
The day before surgery, the first or second day after surgery and the seventh day after surgery
Title
Diaphragm thickness
Description
Assessment of the diaphragmatic thickness by repeating diaphragm echography during the hospital stay
Time Frame
The day before surgery, the first or second day after surgery and the seventh day after surgery
Title
Diaphragm thickening fraction
Description
Assessment of the diaphragmatic thickening fraction (%) by repeating diaphragm echography during the hospital stay
Time Frame
Up to 6 months after surgery (end of Hospital stay)
Title
Digestive function
Description
Time of recovery of normal bowel function. Beginning of oral feeding
Time Frame
The day before surgery, the first or second day after surgery and the seventh day after surgery
Title
Digestive function
Description
Time of recovery of normal bowel function.. Incidence of postoperative nausea and vomiting
Time Frame
Up to 6 months after surgery (end of Hospital stay)
Title
Time of drain removal
Description
Time when the drain are removed of the patient Time when the drain are removed of the patient
Time Frame
Up to 6 months after surgery (end of Hospital stay)
Title
Postoperative complications
Description
occurrence of postoperative respiratory, cardiac, renal, neurological, and infectious complications
Time Frame
Up to 1 month after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
78 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vedat Eljezi
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France

12. IPD Sharing Statement

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

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