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

Pain, Postoperative Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05587608
• Other study ID #: segmental thoracic TEA-spinal
• Status: Completed
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: October 14, 2022

Study information

• Verified date: October 2022
• Source: South Egypt Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: October 14, 2022
• Est. primary completion date: October 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

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.

Locations

Country	Name	City	State
Egypt	South Egypt Cancer Institute, Assiut University, Arab Republic of Egypt	Assiut

Sponsors (2)

Lead Sponsor	Collaborator
South Egypt Cancer Institute	Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MAP	mean arterial pressure	Change from Baseline Systolic Blood Pressure at one day post operative