Clinical trial NCT04313959: Comparison Erect Spine in Cardiac Surgery
Official title: Comparison of Two Anesthetic Techniques in Blocking the Erector Plane of the Spine Bilateral in Cardiac Surgery: a Prospective Randomized Double-blinded Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Spine Erector
Cardiac Surgery
Acute Pain
Chronic Pain
Keywords: Spine erector
Cardiac surgery
Coronary arterial bypass surgery
Acute Pain
Ropivacaine
Dexamethasone
Lead sponsor: Instituto do Coracao
Sponsor class: OTHER_GOV
First posted: 2020-03-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Open cardiac surgeries are characterized by the increased use of opioids and longer extubation times, being post-sternotomy pain one of the causes of greater patient discomfort, plexus blockages have been used more frequently given the good results of anatomical studies and case series that are just beginning to be published. however, there is not enough data to convince the scientific community of its advantages, continuing to carry out its performance due to lack of evidence. Dexamethasone also shows an excellent result blocking the inflammatory chain and it was evidenced that it prolongs the time of blockages when used perineurally in the plexus blockages. This study wants to show the improvement of pain in patients who undergo this type of surgery and also show the advantages of a longer blockage, which can reduce use of analgesic and opioids, as well as decrease the time of hospitalization This is a double-blinded, randomized, clinical trial designed to determine the efficacy of spine erector whit dexamethasone gives more duration of the blockage and less pain after cardiac surgery.

Detailed description: Evaluation of acute pain pos cardiac surgery in patients that who were subjected at myocardial revascularization. We offer Espine erector block (ESP) with linear array Transducer and needle 100mm bilateral as a technique that offer results more hopeful and less invasive in patients with open cardiac surgery. Favoring the implementation of Fastrack anesthesia techniques in cardiac surgery and minimizing complications in this group of patients

Eligibility criteria: Inclusion Criteria:

* Coronary artery bypass graft with cardiopulmonary bypass
* Left ventricular ejection fraction ≥ 45%

Exclusion Criteria:

* Reoperation
* Low cardiac output syndrome
* Preoperative coagulopathy
* Presence of ventricular assist device other than intraaortic ballon pump
* Emergency procedures
* Bacterial or fungal infection in the preceding 30 days
* Active neoplasia
* Allergy or intolerance to steroids
* Allergy to ropivacaine
* Patient refusal
* Participation in other study

Primary outcomes:
measure: Pain intensity score
timeFrame: Within 7 days after cardiac surgery
Secondary outcomes:
measure: Total opioids consumption
timeFrame: Up to 2 postoperative day
measure: Pain intensity score
timeFrame: Up to 90 days
measure: Duration of mechanical ventilation
timeFrame: Within 7 days after cardiac surgery
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Incor - Heart Institute - University of Sao Paulo
Study officials:
affiliation: INCOR FMUSP
name: Luis Alberto Rodriguez Linares, MD
role: PRINCIPAL_INVESTIGATOR
References: