Low-Thoracic Epidural Anesthesia For Laparoscopic Nephrectomy.

NCT ID: NCT04546230

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-19
• Study Completion Date: 2026-12-31

Brief Summary

Laparoscopic nephrectomy is a surgical technique to excise a diseased kidney. It's a minimally invasive technique, so when compared to open surgery, it can mean significantly less post-operative pain, shorter hospital stay, earlier return to work and daily life activities, a more favourable cosmetic result and outcomes similar to that of open surgery.

Recently, advanced laparoscopic surgery has targeted older and high risk patients for general anesthesia; in these patients, regional anesthesia offers several advantages with improved patient satisfaction. Compared with alternative anesthetic techniques, epidural anesthesia may reduce the risks of venous thromboembolism, myocardial infarction, bleeding complications, pneumonia, respiratory depression and renal failure.

The aim of this study is to compare the conventional general anesthetic technique to the regional anesthesia for laparoscopic nephrectomy, in modified lateral decubitus position using low-pressure pneumoperitoneum.

Conditions

Laparoscopic; Nephrectomy; Anesthesia; Epidural

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

E group

Low-Thoracic Epidural Anesthesia

Group Type: EXPERIMENTAL

Low-Thoracic Epidural Anesthesia

Intervention Type: PROCEDURE

Under aseptic conditions and local anesthesia, an epidural catheter will be inserted using the "Prefix Epidural Anesthesia Tray" with an 18 G Tuohy needle & a 20 G catheter at the T7-8 or T8-9 intervertebral space. The epidural catheter will be threaded leaving 3 cm within the epidural space and tapped in place.

Using a mixed preparation of isobaric Bupivacaine 0.5% with Fentanyl 2 μg per ml volume, a bolus dose of 5-10 ml will then be given via the epidural catheter, followed by 5-10 ml/hr as a continuous infusion to be started 1 hour later & continued throughout the procedure.

G group

General Anesthesia

Group Type: ACTIVE_COMPARATOR

General Anesthesia

Intervention Type: PROCEDURE

General anaesthesia will be induced with intra-venous administration of Fentanyl (2 μg/kg), Propofol (2 mg/kg), Atracurium (0.5 mg/kg) and Lidocaine (1 mg/kg). After tracheal intubation, balanced anaesthesia will be maintained with isoflurane in oxygen \& infusion of atracurium at a rate of 0.5 mg/kg/hr; and mechanical ventilation will be provided.

Interventions

Low-Thoracic Epidural Anesthesia

Under aseptic conditions and local anesthesia, an epidural catheter will be inserted using the "Prefix Epidural Anesthesia Tray" with an 18 G Tuohy needle & a 20 G catheter at the T7-8 or T8-9 intervertebral space. The epidural catheter will be threaded leaving 3 cm within the epidural space and tapped in place.

Using a mixed preparation of isobaric Bupivacaine 0.5% with Fentanyl 2 μg per ml volume, a bolus dose of 5-10 ml will then be given via the epidural catheter, followed by 5-10 ml/hr as a continuous infusion to be started 1 hour later & continued throughout the procedure.

Intervention Type: PROCEDURE

General Anesthesia

General anaesthesia will be induced with intra-venous administration of Fentanyl (2 μg/kg), Propofol (2 mg/kg), Atracurium (0.5 mg/kg) and Lidocaine (1 mg/kg). After tracheal intubation, balanced anaesthesia will be maintained with isoflurane in oxygen \& infusion of atracurium at a rate of 0.5 mg/kg/hr; and mechanical ventilation will be provided.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• ASA I - II.
• Adult patients scheduled for laparoscopic nephrectomy.

Exclusion Criteria

• Patient refusal.
• Contraindication to regional anesthesia (e.g., coagulopathy, site infection).
• Allergy to local anesthetics.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nazmy Edward Seif

OTHER

Sponsor Role: lead

Responsible Party

Nazmy Edward Seif

Clinical Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Nazmy S Michael, MD

Role: PRINCIPAL_INVESTIGATOR

Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University

Atef K Salama, MD

Role: STUDY_DIRECTOR

Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University

Locations

Cairo University Hospitals

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Nazmy S Michael, MD

Role: CONTACT

nazmy.seif@gmail.com

01227400808 ext. +2

Atef K Salama, MD

Role: CONTACT

atef.kamel@kasralainy.edu.eg

01001155851 ext. +2

Facility Contacts

Nazmy S Michael, MD

Role: primary

nazmy.seif@gmail.com

01227400808 ext. +2

Atef K Salama, MD

Role: backup

atef.kamel@kasralainy.edu.eg

01001155851 ext. +2

Other Identifiers

LTEALN

Identifier Type: -

Identifier Source: org_study_id