Comparison Erect Spine in Cardiac Surgery

Chronic Pain Clinical Trial

— COESPINE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04313959
• Other study ID #: 27166919.3.0000.0068
• Status: Recruiting
• Phase: Phase 3
• Start date: January 20, 2022
• Est. completion date: April 17, 2023

Study information

• Verified date: July 2022
• Source: Instituto do Coracao
• Contact: Luis Alberto Rodriguez Linares, MD
• Phone: +55 11944450729
• Email: luis.linares[@]usp.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 17, 2023
• Est. primary completion date: February 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Cardiac Surgery
• Chronic Pain
• Spine Erector

Intervention

Drug:
• Ropivacaine 0.2% Injectable Solution
Single-shot ultrasound-guided erector spine plane block of 0.2% ropivacaine
• Ropivacaine 0.2% + Dexamethasone
Addiction of 5 mg/ml dexamethasone in 0.2% ropivacaine solution

Locations

Country	Name	City	State
Brazil	Incor - Heart Institute - University of Sao Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Instituto do Coracao

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Total opioids consumption	The total amount of opioids given by patient	Up to 2 postoperative day
Secondary	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
Secondary	Duration of mechanical ventilation	Duration in hours from the intraoperative intubation up to postoperative extubation	Within 7 days after cardiac surgery