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Completed

NCT Number: NCT03324490

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

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.

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Key information

Conditions

Nephrectomy Anesthesia Lung Diseases Respiratory Tract Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kasr Al-Ainy Hospital, Cairo University

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Thoracic Spinal Anesthesia

Procedure

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

Procedure

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.

Bupivacaine 0.5% (hyperbaric)

Drug

Neuro-axially injected

Other names: Heavy Marcaine

Bupivacaine 0.5% (isobaric)

Drug

Neuro-axially injected

Other names: Marcaine

Fentanyl

Drug

Neuro-axially injected

Dexmedetomidine

Drug

Neuro-axially injected

Primary outcomes

  1. Patient Satisfaction Score

    Time frame: 24 hours

    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).

Secondary outcomes

  1. VAS

    Time frame: 12 hours

    Visual Analogue Score for pain graded from 0-10 [0: no pain, 10: worst pain].

  2. Mean ABP

    Time frame: 12 hours

    Change in Mean Arterial Blood Pressure measured in mmHg.

Sponsors and collaborators

Lead sponsor

Nazmy Edward Seif

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 27, 2017
Registry last updated
Jul 23, 2019

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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