Back to resultsErector Spinae Plane Block in Minimal Invasive Cardiac Surgery
Primary Purpose
Pain, Postoperative
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
ESP Block
general anesthetic
Sponsored by
About this trial
This is an interventional prevention trial for Pain, Postoperative
Eligibility Criteria
Inclusion Criteria:
- elective valve replacement
Exclusion Criteria:
- chroic renal failure
- chronic liver failure
Sites / Locations
- Assiut universityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
ESP block group
control group
Arm Description
patients receive ESP Bock with local anaesthetics
general anaestesia
Outcomes
Primary Outcome Measures
VAS
PAIN SCORES OF PATIENTS
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03825068
Brief Title
Erector Spinae Plane Block in Minimal Invasive Cardiac Surgery
Official Title
Erector Spinae Plane Block in Minimal Invasive Cardiac Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 15, 2018 (Actual)
Primary Completion Date
November 30, 2020 (Anticipated)
Study Completion Date
November 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Studying the effect of erector spinae plane block in patients undergoing minimal invasive cardiac surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ESP block group
Arm Type
Active Comparator
Arm Description
patients receive ESP Bock with local anaesthetics
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
general anaestesia
Intervention Type
Procedure
Intervention Name(s)
ESP Block
Intervention Description
20 ml of lacal anaesthetics will be placed below the erector spinae muscle under ultrasound guide
Intervention Type
Drug
Intervention Name(s)
general anesthetic
Intervention Description
patient receive general anaesthetic only
Primary Outcome Measure Information:
Title
VAS
Description
PAIN SCORES OF PATIENTS
Time Frame
48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
elective valve replacement
Exclusion Criteria:
chroic renal failure
chronic liver failure
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
rasha hamed, lecturer
Phone
01000440773
Email
rashaahmed11@yahoo.com
Facility Information:
Facility Name
Assiut university
City
Assiut
ZIP/Postal Code
71111
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
mohammed Ali Ahmed, MD
Email
amira_salem2015@yahoo.com
12. IPD Sharing Statement
Learn more about this trial
Erector Spinae Plane Block in Minimal Invasive Cardiac Surgery
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