Comparison of Thoracoscopic Talc Pleurodesis by Thoracic Epidural or General Anesthesia

Phase 2

Completed

• Conditions: Pleural Effusion
• Interventions: Procedure: Awake VATS talc pleurodesis; Procedure: Non-awake VATS talc pleurodesis

• Registration Number: NCT01469728
• Lead Sponsor: University of Rome Tor Vergata

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Primary Completion: 2010-09
• Study Completion: 2010-11
• Study First Submitted: 2011-10-28
• Status Verified: 2011-11
• Study First Submitted QC: 2011-11-08
• Last Update Submitted: 2011-11-08
• Study First Posted: 2011-11-10
• Last Update Posted: 2011-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Awake VATS	Awake VATS talc pleurodesis	Thoracoscopic talc pleurodesis performed in awake patients through sole thoracic epidural anesthesia.
Non-awake VATS talc pleurodesis	Non-awake VATS talc pleurodesis	Thoracoscopic talc pleurodesis performed through sole general anesthesia and one-lung ventilation

Primary Outcome Measures

Name	Time	Method
Grade of perioperative medical care (PMC).	participants are followed for the duration of hospital stay; average of 5 days	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).

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Policlinico Tor Vergata University; 🇮🇹 Rome, Italy