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

Study Overview
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Brief Summary
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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.

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

Conditions
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Nephrectomy, Lung Diseases, Anesthesia

Intervention / Treatment
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* Procedure: Thoracic Spinal Anesthesia
* Procedure: Thoracic Epidural Anesthesia
* Drug: Bupivacaine 0.5% (hyperbaric)
* Drug: Bupivacaine 0.5% (isobaric)
* Drug: Fentanyl
* Drug: Dexmedetomidine


Participation Criteria
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Eligibility Criteria
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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

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
Interventional Model Description: Using computer & sealed envelope randomization, patients are assigned to receive either thoracic spinal anesthesia [TSA group: n=30] or thoracic epidural anesthesia [TEA group: n=30].
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TSA group<br>Thoracic Spinal Anesthesia; Bupivacaine 0.5% (hyperbaric) 7.5mg, Fentanyl 25 µg & Dexmedetomidine 5 µg by intrathecal injection | Procedure: Thoracic Spinal Anesthesia<br>* 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.<br>Drug: Bupivacaine 0.5% (hyperbaric)<br>* Neuro-axially injected<br>* Other names: Heavy Marcaine;Drug: Fentanyl<br>* Neuro-axially injected<br>Drug: Dexmedetomidine<br>* Neuro-axially injected<br>|
| Active Comparator: TEA group<br>Thoracic Epidural Anesthesia; Bupivacaine 0.5% (isobaric) 25-50 mg & Fentanyl 10-20 µg by epidural injection | Procedure: Thoracic Epidural Anesthesia<br>* 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.<br>Drug: Bupivacaine 0.5% (isobaric)<br>* Neuro-axially injected<br>* Other names: Marcaine;Drug: Fentanyl<br>* Neuro-axially injected<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mid-thoracic spinal anesthesia, Mid-thoracic epidural anesthesia, Nephrectomy, Lung disease