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

NCT ID: NCT05587608

Last Updated: 2022-11-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2022-10-14

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.

Conditions

Pain, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

combined thoracic segmental spinal epidural anesthesia

Intervention Type: PROCEDURE

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.

General anesthesia group

General anesthesia (control)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: collaborator

South Egypt Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Alaa Ali M. Elzohry

clinical lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Asyut, , Egypt

Countries

Egypt

Other Identifiers

segmental thoracic TEA-spinal

Identifier Type: -

Identifier Source: org_study_id