COESPINE: Comparison Erect Spine in Cardiac Surgery

Sponsor

Instituto do Coracao (Other)

Overall Status

Recruiting

CT.gov ID

NCT04313959

Collaborator

(none)

Enrollment

Location

Arms

14.9

Anticipated Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Spine Erector Cardiac Surgery Acute Pain Chronic Pain	Drug: Ropivacaine 0.2% Injectable Solution Drug: Ropivacaine 0.2% + Dexamethasone	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

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

Actual Study Start Date :

Jan 20, 2022

Anticipated Primary Completion Date :

Feb 25, 2023

Anticipated Study Completion Date :

Apr 17, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Pain intensity score [Within 7 days after cardiac surgery]
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.

Secondary Outcome Measures

Total opioids consumption [Up to 2 postoperative day]
The total amount of opioids given by patient
Pain intensity score [Up to 90 days]
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
Duration of mechanical ventilation [Within 7 days after cardiac surgery]
Duration in hours from the intraoperative intubation up to postoperative extubation