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NCT Number: NCT04546230

Low-Thoracic Epidural Anesthesia For Laparoscopic Nephrectomy.

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.

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Key information

Conditions

Laparoscopic Anesthesia Epidural Nephrectomy

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Low-Thoracic Epidural Anesthesia

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.

General Anesthesia

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.

Primary outcomes

  1. Overall patient satisfaction.

    Time frame: 24 hours

    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].

Study contacts

Contact information is provided by the study sponsor or research team.

Atef K Salama, MD

CONTACT

[email protected]

01001155851 ext. +2

Nazmy S Michael, MD

CONTACT

[email protected]

01227400808 ext. +2

Sponsors and collaborators

Lead sponsor

Nazmy Edward Seif

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Sep 11, 2020
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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