Comparison Erect Spine in Cardiac Surgery (COESPINE)

Instituto do Coracao

Status and phase: Enrolling; Phase 3

Conditions: Cardiac Surgery; Spine Erector; Chronic Pain; Acute Pain

Treatments: Drug: Ropivacaine 0.2% Injectable Solution; Drug: Ropivacaine 0.2% + Dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT04313959

27166919.3.0000.0068

Details and patient eligibility

About

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.

Full 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

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups

Local anesthetic

Active Comparator group

Description:

Patients assigned for local anesthetic group will receive a single-shot ultrasound-guided erector spine plane block with 25 mL of 0.2% of ropivacaine

Treatment:

Drug: Ropivacaine 0.2% Injectable Solution

Local anesthetic + steroid

Active Comparator group

Description:

Patients assigned for local anesthetic + steroid group will receive a single-shot ultrasound-guided erector spine block plane with 25 mL of 0.2% of ropivacaine with 5 mg dexamethasone

Treatment:

Drug: Ropivacaine 0.2% + Dexamethasone

Drug: Ropivacaine 0.2% Injectable Solution