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Comparison Erect Spine in Cardiac Surgery (COESPINE)

Primary Purpose

Spine Erector, Cardiac Surgery, Acute Pain

Status
Recruiting
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Ropivacaine 0.2% Injectable Solution
Ropivacaine 0.2% + Dexamethasone
Sponsored by
Instituto do Coracao
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Spine Erector focused on measuring Spine erector, Cardiac surgery, Coronary arterial bypass surgery, Acute Pain, Ropivacaine, Dexamethasone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Incor - Heart Institute - University of Sao PauloRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Local anesthetic

Local anesthetic + steroid

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Total opioids consumption
The total amount of opioids given by patient
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
Duration of mechanical ventilation
Duration in hours from the intraoperative intubation up to postoperative extubation

Full Information

First Posted
March 17, 2020
Last Updated
July 14, 2022
Sponsor
Instituto do Coracao
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1. Study Identification

Unique Protocol Identification Number
NCT04313959
Brief Title
Comparison Erect Spine in Cardiac Surgery
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 20, 2022 (Actual)
Primary Completion Date
February 25, 2023 (Anticipated)
Study Completion Date
April 17, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto do Coracao

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spine Erector, Cardiac Surgery, Acute Pain, Chronic Pain
Keywords
Spine erector, Cardiac surgery, Coronary arterial bypass surgery, Acute Pain, Ropivacaine, Dexamethasone

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Local anesthetic
Arm Type
Active Comparator
Arm Description
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
Arm Title
Local anesthetic + steroid
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Ropivacaine 0.2% Injectable Solution
Other Intervention Name(s)
Do not have
Intervention Description
Single-shot ultrasound-guided erector spine plane block of 0.2% ropivacaine
Intervention Type
Drug
Intervention Name(s)
Ropivacaine 0.2% + Dexamethasone
Other Intervention Name(s)
Do not have
Intervention Description
Addiction of 5 mg/ml dexamethasone in 0.2% ropivacaine solution
Primary Outcome Measure Information:
Title
Pain intensity score
Description
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.
Time Frame
Within 7 days after cardiac surgery
Secondary Outcome Measure Information:
Title
Total opioids consumption
Description
The total amount of opioids given by patient
Time Frame
Up to 2 postoperative day
Title
Pain intensity score
Description
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
Time Frame
Up to 90 days
Title
Duration of mechanical ventilation
Description
Duration in hours from the intraoperative intubation up to postoperative extubation
Time Frame
Within 7 days after cardiac surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luis Alberto Rodriguez Linares, MD
Phone
+55 11944450729
Email
luis.linares@usp.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luis Alberto Rodriguez Linares, MD
Organizational Affiliation
INCOR FMUSP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Incor - Heart Institute - University of Sao Paulo
City
Sao Paulo
ZIP/Postal Code
05403000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Filomena RG Galas
Phone
+551126615232
Email
filomenagalas@hotmail.com

12. IPD Sharing Statement

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Comparison Erect Spine in Cardiac Surgery

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