Comparison of Thoracoscopic Talc Pleurodesis by Thoracic Epidural or General Anesthesia

Study Overview
=================
Brief Summary
-----------------
Video-assisted thoracoscopic surgery (VATS) talc pleurodesis is often carried out in patients with malignant recurrent pleural effusion to relieve symptoms and prevent recurrence. General anesthesia and one lung ventilation is the standard type of anesthesia employed for VATS although recently, thoracic epidural anesthesia (TEA) in awake spontaneously ventilating patients is being increasingly employed to perform several cardio-thoracic surgery procedures in an attempt of minimize operative risks and facilitate resumption of daily-life activity. The investigators have reasoned that for a simple and palliative procedure such as talc pleurodesis in cancer patients is, use of general anesthesia and one-lung ventilation might be considered a potential cause of morbidity and delayed recovery. The investigators have also hypothesized TEA could be considered an optimal type of anesthesia in this setting leading to a fast recovery a reduced overall workload in medical care. In this single-center randomized study, the investigators have comparatively assessed the impact of awake TEA versus general anesthesia and one-lung ventilation on comprehensive results of VATS talc pleurodesis.

Official Title
-----------------
Randomized Study of Thoracoscopic Talc Pleurodesis Performed by Thoracic Epidural or General Anesthesia

Conditions
-----------------
Pleural Effusion

Intervention / Treatment
-----------------
* Procedure: Non-awake VATS talc pleurodesis
* Procedure: Awake VATS talc pleurodesis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Recurrent pleural effusion at the computed tomography occupying at least 1/3 of the hemithorax in patients with recent history of malignancy. Karnofsky performance status ≥ 50 ASA score II-III Acceptance of the randomly assigned anesthesia protocol Radiologic evidence of lung re-expansion after previous drainage/thoracentesis Absence of blood clotting disorders (INR < 1.5) No contraindications to TEA No neurological or psychiatric disturbance contraindicating awake surgery Exclusion Criteria: Patients refusal of random assignment to treatment arm Patients refusal or noncompliance to TEA Patients refusal or noncompliance to general anesthesia and one-lung ventilation Unfavourable anatomy for TEA Previous surgery of the thoracic spine Coagulation disorders (thromboplastin time < 80%, prothrombin time > 40 sec, platelet count < 200/nL or bleeding disorders
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Awake VATS<br>Thoracoscopic talc pleurodesis performed in awake patients through sole thoracic epidural anesthesia. | Procedure: Awake VATS talc pleurodesis<br>* Thoracoscopic talc pleurodesis performed in awake patients through sole thoracic epidural anesthesia.<br>|
| Active Comparator: Non-awake VATS talc pleurodesis<br>Thoracoscopic talc pleurodesis performed through sole general anesthesia and one-lung ventilation | Procedure: Non-awake VATS talc pleurodesis<br>* Thoracoscopic talc pleurodesis performed through sole general anesthesia and one-lung ventilation<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Grade of perioperative medical care (PMC). | PMC is aimed at evaluating the overall workload in medical care throughout the the entire perioperative period and until discharge. PMC was computed as a comprehensive multidimensional variable including hospitalization time and extra-routine nursing/clinical/pharmacological requirements and costs(grades 1-3). | participants are followed for the duration of hospital stay; average of 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain |  | Postoperatively at 3h,12h and 24h | 
| Perioperative changes in blood gases | Ratio of arterial oxygen tension to fraction of inspired oxygen (PaO2/FiO2), arterial carbon dioxide tension (PaCO2) | Imediately before operation, at end-procedure, postoperatively at 1h and 24h | 
| Perioperative changes in cardiocirculatory variables including heart rate (HR) and mean arteial pressure (MAP) |  | Immediately before the operation, at end-procedure, postoperatively at 1h and 24h | 
| Postoperative changes in spirometric variables | Forced expiratory volume in one second(FEV1), forced vital capacity (FVC), peak expiratory flow (PEF) | Postoperatively at 3h,12h and 24h | 
| Morbidity |  | from day of operation to discharge; average, 5 days | 
| Hospital stay |  | from day of operation to discharge; average, 5 days | 
| Redo pleurodesis | Need of reoperation because of recurrence of the pleural effusion | From date of operation until the date of redo pleurodesis or assessed every 6 months or until date of death from any cause | 
| Operative mortality |  | from day of operation for up to 30 days postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
VATS, awake thoracic surgery, pleurodesis, talc, TEA, epidural anesthesia, Video-Assisted, Anesthesia Epidural