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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04313959
Other study ID # 27166919.3.0000.0068
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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