Low-Thoracic Epidural Anesthesia For Laparoscopic Nephrectomy.

Study Overview
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Brief Summary
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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.

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

Conditions
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Laparoscopic, Nephrectomy, Anesthesia, Epidural

Intervention / Treatment
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* Procedure: Low-Thoracic Epidural Anesthesia
* Procedure: General Anesthesia


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: E group<br>Low-Thoracic Epidural Anesthesia | Procedure: Low-Thoracic Epidural Anesthesia<br>* 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.<br>|
| Active Comparator: G group<br>General Anesthesia | Procedure: General Anesthesia<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epidural Anesthesia, Low-thoracic, Laparoscopic nephrectomy