Comparison of Thoracoscopic Talc Pleurodesis by Thoracic Epidural or General Anesthesia

University of Rome Tor Vergata

Status and phase: Completed; Phase 2

Conditions: Pleural Effusion

Treatments: Procedure: Non-awake VATS talc pleurodesis; Procedure: Awake VATS talc pleurodesis

Study type: Interventional

Funder types: Other

Identifiers

NCT01469728

107/07

#20112 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Awake VATS

Experimental group

Description:

Thoracoscopic talc pleurodesis performed in awake patients through sole thoracic epidural anesthesia.

Treatment:

Procedure: Awake VATS talc pleurodesis

Non-awake VATS talc pleurodesis

Active Comparator group

Description:

Thoracoscopic talc pleurodesis performed through sole general anesthesia and one-lung ventilation

Treatment:

Procedure: Non-awake VATS talc pleurodesis