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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03324490
• Other study ID #: TSEANORLDP60
• Status: Completed
• Phase: N/A
• Start date: November 1, 2017
• Est. completion date: June 1, 2018

Study information

• Verified date: July 2019
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 1, 2018
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Lung Diseases
• Nephrectomy

Intervention

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.
• 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% (hyperbaric)
Neuro-axially injected
• Bupivacaine 0.5% (isobaric)
Neuro-axially injected
• Fentanyl
Neuro-axially injected
• Dexmedetomidine
Neuro-axially injected

Locations

Country	Name	City	State
Egypt	Kasr Al-Ainy Hospital, Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Nazmy Edward Seif

Country where clinical trial is conducted

Egypt, 

Outcome

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