NCT04546230

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
6mo left

Started Sep 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress91%
Sep 2020Dec 2026

First Submitted

Initial submission to the registry

September 6, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 11, 2020

Completed
8 days until next milestone

Study Start

First participant enrolled

September 19, 2020

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

January 12, 2026

Status Verified

January 1, 2026

Enrollment Period

6.2 years

First QC Date

September 6, 2020

Last Update Submit

January 8, 2026

Conditions

LaparoscopicNephrectomyAnesthesiaEpidural

Keywords

Epidural AnesthesiaLow-thoracicLaparoscopic nephrectomy

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

E group

EXPERIMENTAL

Low-Thoracic Epidural Anesthesia

Procedure: Low-Thoracic Epidural Anesthesia

G group

ACTIVE COMPARATOR

General Anesthesia

Procedure: General Anesthesia

Interventions

General AnesthesiaPROCEDURE

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.

G group
Low-Thoracic Epidural AnesthesiaPROCEDURE

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.

E group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University Hospitals

Cairo, Egypt

RECRUITING

MeSH Terms

Interventions

Anesthesia, General

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and Analgesia

Study Officials

  • Nazmy S Michael, MD

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

    PRINCIPAL INVESTIGATOR

  • Atef K Salama, MD

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

    STUDY DIRECTOR

Central Study Contacts

Nazmy S Michael, MD

CONTACT

01227400808nazmy.seif@gmail.com

Atef K Salama, MD

CONTACT

01001155851atef.kamel@kasralainy.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

September 6, 2020

First Posted

September 11, 2020

Study Start

September 19, 2020

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

January 12, 2026

Record last verified: 2026-01

Locations

EG(1)