Back to resultsPerioperative Thoracotomy Analgesia; Different Analgesic Modalities
Primary Purpose
Analgesia
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
serratus anterior block
thoracic epidural
erector spinae block
Sponsored by
About this trial
This is an interventional prevention trial for Analgesia
Eligibility Criteria
Inclusion Criteria:
- patients scheduled for thoracotomy age 18-65
Exclusion Criteria:
- patient refusal coagulation defects abnormal kidney or liver functions local infection at site of block bone metastases
Sites / Locations
- Department of anesthesia and pain medicine. National Cancer Institute
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
thoracic epidural
serratus anterior block
erector spinae block
Arm Description
thoracic epidural will be done before induction of general anesthesia
ultrasound guided serratus anterior block will be done after induction of general anesthesia
ultrasound guided erector spinae block will be done after induction of general anesthesia
Outcomes
Primary Outcome Measures
visual analogue score
minimum value 0 and maximum value 10
Secondary Outcome Measures
mean arterial blood pressure
measurement of mean arterial blood pressure
Full Information
NCT ID
NCT04264689
First Posted
February 9, 2020
Last Updated
December 3, 2020
Sponsor
National Cancer Institute, Egypt
1. Study Identification
Unique Protocol Identification Number
NCT04264689
Brief Title
Perioperative Thoracotomy Analgesia; Different Analgesic Modalities
Official Title
Perioperative Thoracotomy Analgesia; Different Analgesic Modalities
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
March 2, 2020 (Actual)
Primary Completion Date
October 28, 2020 (Actual)
Study Completion Date
November 3, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cancer Institute, Egypt
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
the study aim is to compare the analgesic effect of thoracic epidural versus serratus plane block versus erector spinae block in thoracic surgeries
Detailed Description
comparing the analgesic effect of thoracic epidural versus serratus plane block versus erector spinae block in thoracic surgeries regarding pain control and possible side effects
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Analgesia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
thoracic epidural
Arm Type
Active Comparator
Arm Description
thoracic epidural will be done before induction of general anesthesia
Arm Title
serratus anterior block
Arm Type
Experimental
Arm Description
ultrasound guided serratus anterior block will be done after induction of general anesthesia
Arm Title
erector spinae block
Arm Type
Experimental
Arm Description
ultrasound guided erector spinae block will be done after induction of general anesthesia
Intervention Type
Procedure
Intervention Name(s)
serratus anterior block
Intervention Description
ultrasound guided block
Intervention Type
Procedure
Intervention Name(s)
thoracic epidural
Intervention Description
thoracic epidural
Intervention Type
Procedure
Intervention Name(s)
erector spinae block
Intervention Description
ultrasound guided block
Primary Outcome Measure Information:
Title
visual analogue score
Description
minimum value 0 and maximum value 10
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
mean arterial blood pressure
Description
measurement of mean arterial blood pressure
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients scheduled for thoracotomy age 18-65
Exclusion Criteria:
patient refusal coagulation defects abnormal kidney or liver functions local infection at site of block bone metastases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
walaa Y elsabeeny, MD
Organizational Affiliation
Lecturer
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of anesthesia and pain medicine. National Cancer Institute
City
Cairo
ZIP/Postal Code
11796
Country
Egypt
12. IPD Sharing Statement
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Perioperative Thoracotomy Analgesia; Different Analgesic Modalities
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