US-guided Thoracic Spinal Epidural Anesthesia VS GA for Abdominal and Breast Surgeries
US-guided Combined Segmental Thoracic Spinal Epidural Anesthesia in Comparison With General Anesthesia for Upper Abdominal and Breast Surgeries - A Randomized Control Study
1 other identifier
interventional
63
1 country
1
Brief Summary
Ultrasound-guided combined thoracic segmental spinal epidural anesthesia in comparison with general anesthesia in upper abdominal and breast surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2022
CompletedFirst Submitted
Initial submission to the registry
October 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 14, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 14, 2022
CompletedFirst Posted
Study publicly available on registry
October 20, 2022
CompletedNovember 2, 2022
October 1, 2022
8 months
October 14, 2022
October 29, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
MAP
mean arterial pressure
Change from Baseline Systolic Blood Pressure at one day post operative
Study Arms (2)
ultrasound-guided thoracic segmental spinal group
ACTIVE COMPARATORgiven ultrasound-guided thoracic segmental spinal heavy Marcaine plus 25 ug fentanyl at the level of T10 interlaminar space.
General anesthesia group
NO INTERVENTIONGeneral anesthesia (control)
Interventions
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.
Eligibility Criteria
You may qualify if:
- All upper abdominal and laparoscopic surgeries
- ASA I-III CLASS
- Age between 18 and 60
You may not qualify if:
- Contraindication of regional ASA More than III Age less than18 or more than 60 Psychological troubles
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- South Egypt Cancer Institutelead
- Assiut Universitycollaborator
Study Sites (1)
South Egypt Cancer Institute, Assiut University, Arab Republic of Egypt
Asyut, 0020, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- clinical lecturer
Study Record Dates
First Submitted
October 14, 2022
First Posted
October 20, 2022
Study Start
March 1, 2022
Primary Completion
October 14, 2022
Study Completion
October 14, 2022
Last Updated
November 2, 2022
Record last verified: 2022-10