Comparison Erect Spine in Cardiac Surgery (COESPINE)

Comparison of Two Anesthetic Techniques in Blocking the Erector Plane of the Spine Bilateral in Cardiac Surgery: a Prospective Randomized Double-blinded Clinical Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Pain; Acute Pain; Cardiac Surgery; Spine Erector
• Intervention / Treatment: Drug: Ropivacaine 0.2% Injectable Solution; Drug: Ropivacaine 0.2% + Dexamethasone

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

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Luis Alberto Rodriguez Linares, MD; Phone Number: +55 11944450729; Email: luis.linares@usp.br

Study Locations

• Brazil
  • Sao Paulo, Brazil, 05403000
    • Recruiting
    • Incor - Heart Institute - University of Sao Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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	Drug: Ropivacaine 0.2% Injectable Solution; Single-shot ultrasound-guided erector spine plane block of 0.2% ropivacaine; Other Names: Do not have
ACTIVE_COMPARATOR: 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	Drug: Ropivacaine 0.2% Injectable Solution; Single-shot ultrasound-guided erector spine plane block of 0.2% ropivacaine; Other Names: Do not have; Drug: Ropivacaine 0.2% + Dexamethasone; Addiction of 5 mg/ml dexamethasone in 0.2% ropivacaine solution; Other Names: Do not have

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity score	Changes in Numeric Rating Scale (NRS) and visual analogue scale (VAS) will be recorded daily at postoperative 1 to 7 day or until the patient's hospital discharge if this occurs before 7 days.; Numerical rating scales A numerical rating scale (NRS) requires the patient to rate their pain on a defined scale. For example, 0-10 where 0 is no pain and 10 is the worst pain imaginable; VAS have also been utilized in EMA research. VAS are measures of subjective or behavioral experience (e.g., pain, physical exercise). They are typically presented as a 10 cm line with descriptive anchors at each end, such as "completed all prescribed activities today" to "completed none of the prescribed activities today." Respondents place a vertical line through the point on the scale that best fits their experience with that construct at that moment.	Within 7 days after cardiac surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total opioids consumption	The total amount of opioids given by patient	Up to 2 postoperative day
Pain intensity score	Changes inThe Brief Pain Inventory (BPI).will be recorded after discharge at 30 days, 60 days and 90 days after surgery *The Brief Pain Inventory (BPI) rapidly assesses the severity of pain and its impact on functioning; BPI Pain Items, Least pain in last 24 hours, Pain on average, Pain right now, Worst pain in last 24 hours; BPI Interference Items, Mood, Walking ability, Normal work (including housework), General activity, Relations with other people, Sleep, Enjoyment of life	Up to 90 days
Duration of mechanical ventilation	Duration in hours from the intraoperative intubation up to postoperative extubation	Within 7 days after cardiac surgery

Collaborators and Investigators

• Sponsor: Instituto do Coracao
• Investigators: Principal Investigator: Luis Alberto Rodriguez Linares, MD, INCOR FMUSP

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 20, 2022
• Primary Completion (ANTICIPATED): February 25, 2023
• Study Completion (ANTICIPATED): April 17, 2023

Study Registration Dates

• First Submitted: March 17, 2020
• First Submitted That Met QC Criteria: March 17, 2020
• First Posted (ACTUAL): March 18, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 18, 2022
• Last Update Submitted That Met QC Criteria: July 14, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Dexamethasone; Cardiac surgery; Ropivacaine; Acute Pain; Spine erector; Coronary arterial bypass surgery
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain; Acute Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Anesthetics, Local; Dexamethasone; Ropivacaine
• Other Study ID Numbers: 27166919.3.0000.0068

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No