Low-Thoracic Epidural Anesthesia For Laparoscopic Nephrectomy.

Low-Thoracic Epidural Anesthesia For Laparoscopic Nephrectomy In Adult Patients.

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.

Study Overview

• Status: Recruiting
• Conditions: Anesthesia; Nephrectomy; Epidural; Laparoscopic
• Intervention / Treatment: Procedure: Low-Thoracic Epidural Anesthesia; Procedure: General Anesthesia

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nazmy S Michael, MD; Phone Number: +2 01227400808; Email: nazmy.seif@gmail.com
• Study Contact Backup: Name: Atef K Salama, MD; Phone Number: +2 01001155851; Email: atef.kamel@kasralainy.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Cairo University hospitals
    • Contact: Nazmy S Michael, MD; Phone Number: +2 01227400808; Email: nazmy.seif@gmail.com
    • Contact: Atef K Salama, MD; Phone Number: +2 01001155851; Email: atef.kamel@kasralainy.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: E group; Low-Thoracic Epidural Anesthesia	Procedure: 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.
Active Comparator: G group; General Anesthesia	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall patient satisfaction.	The overall degree of patients' satisfaction will be assessed using a "5-point patient satisfaction rating scale" according to Likert scale [where: very unsatisfied=1/5, unsatisfied=2/5, neutral=3/5, satisfied=4/5, and very satisfied=5/5].	24 hours

Collaborators and Investigators

• Sponsor: Nazmy Edward Seif
• Investigators: Principal Investigator: Nazmy S Michael, MD, Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University; Study Director: Atef K Salama, MD, Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2020
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: September 6, 2020
• First Submitted That Met QC Criteria: September 6, 2020
• First Posted (Actual): September 11, 2020

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Laparoscopic nephrectomy; Epidural Anesthesia; Low-thoracic
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: LTEALN

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