Comparison Erect Spine in Cardiac Surgery

NCT ID: NCT04313959

Last Updated: 2022-07-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-20
• Study Completion Date: 2023-04-17

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

Conditions

Spine Erector; Cardiac Surgery; Acute Pain; Chronic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Local anesthetic

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

Group Type: ACTIVE_COMPARATOR

Ropivacaine 0.2% Injectable Solution

Intervention Type: DRUG

Single-shot ultrasound-guided erector spine plane block of 0.2% ropivacaine

Local anesthetic + steroid

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

Group Type: ACTIVE_COMPARATOR

Ropivacaine 0.2% Injectable Solution

Intervention Type: DRUG

Single-shot ultrasound-guided erector spine plane block of 0.2% ropivacaine

Ropivacaine 0.2% + Dexamethasone

Intervention Type: DRUG

Addiction of 5 mg/ml dexamethasone in 0.2% ropivacaine solution

Interventions

Ropivacaine 0.2% Injectable Solution

Single-shot ultrasound-guided erector spine plane block of 0.2% ropivacaine

Intervention Type: DRUG

Ropivacaine 0.2% + Dexamethasone

Addiction of 5 mg/ml dexamethasone in 0.2% ropivacaine solution

Intervention Type: DRUG

Other Intervention Names

Do not have; Do not have

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto do Coracao

OTHER_GOV

Sponsor Role: lead

Responsible Party

Filomena R B G Galas

Associate Professor of Anesthesiology at University São Paulo Medical School

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Luis Alberto Rodriguez Linares, MD

Role: PRINCIPAL_INVESTIGATOR

INCOR FMUSP

Locations

Incor - Heart Institute - University of Sao Paulo

São Paulo, , Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Luis Alberto Rodriguez Linares, MD

Role: CONTACT

luis.linares@usp.br

+55 11944450729

Facility Contacts

Filomena RG Galas

Role: primary

filomenagalas@hotmail.com

+551126615232

Other Identifiers

27166919.3.0000.0068

Identifier Type: -

Identifier Source: org_study_id