Thoracic Spinal Versus Epidural Anesthesia for Nephrectomy in Obstructive/Restrictive Lung Disease Patients

Comparative Study of Mid-thoracic Spinal Versus Epidural Anesthesia for Open Nephrectomy in Patients With Obstructive/Restrictive Lung Disease: A Randomized Controlled Study

Patients with respiratory disease have an increased risk of developing complications perioperatively. The use of regional anesthesia decreases this risk with better postoperative outcome. The aim of this study is to compare the safety and efficacy of thoracic spinal versus thoracic epidural anesthesia for open nephrectomy in patients with obstructive/restrictive lung disease.

Study Overview

• Status: Completed
• Conditions: Lung Diseases; Anesthesia; Nephrectomy
• Intervention / Treatment: Procedure: Thoracic Spinal Anesthesia; Drug: Bupivacaine 0.5% (hyperbaric); Drug: Fentanyl; Drug: Dexmedetomidine; Procedure: Thoracic Epidural Anesthesia; Drug: Bupivacaine 0.5% (isobaric)

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Kasr Al-Ainy Hospital, Cairo University

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• ASA class II or III
• Mild to moderate obstructive or restrictive lung disease
• Open nephrectomy candidate patients

Exclusion Criteria:

• Any condition contra-indicating regional anesthesia
• Allergic to any of the drugs used during the procedure

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: TSA group; Thoracic Spinal Anesthesia; Bupivacaine 0.5% (hyperbaric) 7.5mg, Fentanyl 25 µg & Dexmedetomidine 5 µg by intrathecal injection	Procedure: Thoracic Spinal Anesthesia; Spinal anesthesia will be performed for patients of the TSA group at the T7-T8 intervertebral space, using a 27 G pencil point needle with an introducer (Braun Melsungen, Melsungen, Germany). When correct placement is confirmed by the free flow of clear CSF, 1.5 ml of hyperbaric Bupivacaine 0.5% (7.5 mg) in addition to 0.5 ml Fentanyl (25 μg) & 5 μg dexmedetomidine will be injected.; Drug: Bupivacaine 0.5% (hyperbaric); Neuro-axially injected; Other Names: Heavy Marcaine; Drug: Fentanyl; Neuro-axially injected; Drug: Dexmedetomidine; Neuro-axially injected
Active Comparator: TEA group; Thoracic Epidural Anesthesia; Bupivacaine 0.5% (isobaric) 25-50 mg & Fentanyl 10-20 µg by epidural injection	Drug: Fentanyl; Neuro-axially injected; Procedure: Thoracic Epidural Anesthesia; Epidural anesthesia will be performed for patients of the TEA group at the T7-T8 intervertebral space, using the "Prefix Custom Epidural Anesthesia Tray" with an 18 G Tuohy epidural needle & a 20 G epidural catheter. Patients will initially receive 5-10 ml of a mixed preparation of 0.5% isobaric Bupivacaine with 2 μg Fentanyl per ml volume as a bolus dose via the epidural catheter, this will be followed by a continuous infusion of 5-10 ml/hr started 1 hour after the bolus dose & continued throughout the procedure.; Drug: Bupivacaine 0.5% (isobaric); Neuro-axially injected; Other Names: Marcaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Satisfaction Score	Patient Satisfaction Score defines the degree of patient satisfaction with the anesthetic experience and is assessed after recovery. It is graded as excellent "E" (best score), fair "F" & poor "P" (worst score).	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VAS	Visual Analogue Score for pain graded from 0-10 [0: no pain, 10: worst pain].	12 hours
Mean ABP	Change in Mean Arterial Blood Pressure measured in mmHg.	12 hours

Collaborators and Investigators

• Sponsor: Nazmy Edward Seif
• Investigators: Study Director: Ahmed M El-Badawy, MD, Kasr Al-Ainy Hospital, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2017
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: October 18, 2017
• First Submitted That Met QC Criteria: October 24, 2017
• First Posted (Actual): October 27, 2017

Study Record Updates

• Last Update Posted (Actual): July 23, 2019
• Last Update Submitted That Met QC Criteria: July 22, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Nephrectomy; Lung disease; Mid-thoracic spinal anesthesia; Mid-thoracic epidural anesthesia
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anesthetics, Local; Anesthetics; Fentanyl; Dexmedetomidine; Bupivacaine
• Other Study ID Numbers: TSEANORLDP60

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