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

NCT05160298 | Completed Phase 2

• 1 other identifier: ESB-Sterno (RBHP2021ELJEZI)
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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

Conditions

Cadiac Surgery; Median Sternotomy; Regional Anesthesia; Postoperative Pain

Keywords

Postoperative analgesia; Erector spinae plane block; Local anesthetics; Ropivacaine; Sternotomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (18)

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

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

• Change of pain score during central venous pressure measuring

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

• Change of sternal pain score at rest

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

• Change of dorsal pain evaluation at rest

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

• Opioid consumption

  48 hours after intervention

Study Arms (2)

Ropivacaine group

EXPERIMENTAL

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

Control group

SHAM COMPARATOR

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

Other: Control group

Interventions

Ropivacaine 0,2% Injectable Solution DRUG

Echo-guided bilateral erector spinae block

Ropivacaine group

Control group OTHER

Sham block

Control group

Eligibility Criteria

• Age: 18 Years - 78 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU

Clermont-Ferrand, 63000, France

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Vedat Eljezi

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: * 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.

Study Record Dates

• First Submitted: October 18, 2021
• First Posted: December 16, 2021
• Study Start: October 20, 2021
• Primary Completion: November 20, 2022
• Study Completion: December 20, 2022
• Last Updated: July 6, 2023

Record last verified: 2023-07

Locations

FR (1)