US-guided Thoracic Spinal Epidural Anesthesia VS GA for Abdominal and Breast Surgeries

October 29, 2022 updated by: Alaa Ali M. Elzohry, South Egypt Cancer Institute

US-guided Combined Segmental Thoracic Spinal Epidural Anesthesia in Comparison With General Anesthesia for Upper Abdominal and Breast Surgeries - A Randomized Control Study

Ultrasound-guided combined thoracic segmental spinal epidural anesthesia in comparison with general anesthesia in upper abdominal and breast surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt, 0020
        • South Egypt Cancer Institute, Assiut University, Arab Republic of Egypt

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ultrasound-guided thoracic segmental spinal group
given ultrasound-guided thoracic segmental spinal heavy Marcaine plus 25 ug fentanyl at the level of T10 interlaminar space.
Procedure: combined thoracic segmental spinal epidural anesthesia
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.
No Intervention: General anesthesia group
General anesthesia (control)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MAP
Time Frame: Change from Baseline Systolic Blood Pressure at one day post operative
mean arterial pressure
Change from Baseline Systolic Blood Pressure at one day post operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

South Egypt Cancer Institute

Collaborators

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2022

Primary Completion (Actual)

October 14, 2022

Study Completion (Actual)

October 14, 2022

Study Registration Dates

First Submitted

October 14, 2022

First Submitted That Met QC Criteria

October 17, 2022

First Posted (Actual)

October 20, 2022

Study Record Updates

Last Update Posted (Actual)

November 2, 2022

Last Update Submitted That Met QC Criteria

October 29, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • segmental thoracic TEA-spinal

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain, Postoperative

Clinical Trials on combined thoracic segmental spinal epidural anesthesia

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United Arab Emirates

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe