Back to resultsUS-guided Thoracic Spinal Epidural Anesthesia VS GA for Abdominal and Breast Surgeries
Primary Purpose
Pain, Postoperative
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
combined thoracic segmental spinal epidural anesthesia
Sponsored by
About this trial
This is an interventional prevention trial for Pain, Postoperative
Eligibility Criteria
Inclusion Criteria:
- All upper abdominal and laparoscopic surgeries
- ASA I-III CLASS
- Age between 18 and 60
Exclusion Criteria:
Contraindication of regional ASA More than III Age less than18 or more than 60 Psychological troubles
Sites / Locations
- South Egypt Cancer Institute, Assiut University, Arab Republic of Egypt
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
ultrasound-guided thoracic segmental spinal group
General anesthesia group
Arm Description
given ultrasound-guided thoracic segmental spinal heavy Marcaine plus 25 ug fentanyl at the level of T10 interlaminar space.
General anesthesia (control)
Outcomes
Primary Outcome Measures
MAP
mean arterial pressure
Secondary Outcome Measures
Full Information
NCT ID
NCT05587608
First Posted
October 14, 2022
Last Updated
October 29, 2022
Sponsor
South Egypt Cancer Institute
Collaborators
Assiut University
1. Study Identification
Unique Protocol Identification Number
NCT05587608
Brief Title
US-guided Thoracic Spinal Epidural Anesthesia VS GA for Abdominal and Breast Surgeries
Official Title
US-guided Combined Segmental Thoracic Spinal Epidural Anesthesia in Comparison With General Anesthesia for Upper Abdominal and Breast Surgeries - A Randomized Control Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
October 14, 2022 (Actual)
Study Completion Date
October 14, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
South Egypt Cancer Institute
Collaborators
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
No
5. Study Description
Brief Summary
Ultrasound-guided combined thoracic segmental spinal epidural anesthesia in comparison with general anesthesia in upper abdominal and breast surgery.
Detailed Description
The first group (S) will be given ultrasound-guided thoracic segmental spinal anesthesia at the level of T10 interlaminar space, patients will be in sitting position, a combined spinal epidural tray will be used. In this group, SonoSite C60x/5-2 MHz M-Turbo Convex Probe ultrasound Transducer to identify the T10 interlaminar space and after complete sterilization, the investigator will introduce the epidural needle in a Paramedian in plan approach till the epidural space. The spinal needle is then introduced through the epidural needle not more than 0.5 cm beyond the Dura matter. 2cc of heavy Marcaine plus 25 ug fentanyl are injected through the spinal needle. The epidural catheter is then threaded through the Touhy needle after withdrawal of the spinal needle to keep only 4cm up in the epidural space.
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ultrasound-guided thoracic segmental spinal group
Arm Type
Active Comparator
Arm Description
given ultrasound-guided thoracic segmental spinal heavy Marcaine plus 25 ug fentanyl at the level of T10 interlaminar space.
Arm Title
General anesthesia group
Arm Type
No Intervention
Arm Description
General anesthesia (control)
Intervention Type
Procedure
Intervention Name(s)
combined thoracic segmental spinal epidural anesthesia
Intervention Description
ultrasound guided thoracic segmental spinal anesthesia at the level of T10 interlaminar space , patients will be in sitting position, spinal needle is then introduced through the epidural needle not more than 0.5 cm beyond the Dura matter. 2cc of heavy Marcaine plus 25 ug fentanyl are injected through the spinal needle.
Primary Outcome Measure Information:
Title
MAP
Description
mean arterial pressure
Time Frame
Change from Baseline Systolic Blood Pressure at one day post operative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All upper abdominal and laparoscopic surgeries
ASA I-III CLASS
Age between 18 and 60
Exclusion Criteria:
Contraindication of regional ASA More than III Age less than18 or more than 60 Psychological troubles
Facility Information:
Facility Name
South Egypt Cancer Institute, Assiut University, Arab Republic of Egypt
City
Assiut
ZIP/Postal Code
0020
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
US-guided Thoracic Spinal Epidural Anesthesia VS GA for Abdominal and Breast Surgeries
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