Comparison of Thoracoscopic Talc Pleurodesis by Thoracic Epidural or General Anesthesia

Condition(s) targeted: Pleural Effusion

Intervention: Non-awake VATS talc pleurodesis (Procedure); Awake VATS talc pleurodesis (Procedure)

Phase: Phase 2

Status: Completed

Sponsored by: University of Rome Tor Vergata

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Primary outcome: Grade of perioperative medical care (PMC).

Secondary outcome:

Postoperative pain

Perioperative changes in blood gases

Perioperative changes in cardiocirculatory variables including heart rate (HR) and mean arteial pressure (MAP)

Postoperative changes in spirometric variables

Morbidity

Hospital stay

Redo pleurodesis

Operative mortality

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

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

Policlinico Tor Vergata University, Rome 00133, Italy

Related publications:

Pompeo E, Tacconi F, Mineo TC. Comparative results of non-resectional lung volume reduction performed by awake or non-awake anesthesia. Eur J Cardiothorac Surg. 2011 Apr;39(4):e51-8. doi: 10.1016/j.ejcts.2010.11.071.

Pompeo E, Tacconi F, Frasca L, Mineo TC. Awake thoracoscopic bullaplasty. Eur J Cardiothorac Surg. 2011 Jun;39(6):1012-7. doi: 10.1016/j.ejcts.2010.09.029. Epub 2010 Oct 25.

Vanni G, Tacconi F, Sellitri F, Ambrogi V, Mineo TC, Pompeo E. Impact of awake videothoracoscopic surgery on postoperative lymphocyte responses. Ann Thorac Surg. 2010 Sep;90(3):973-8. doi: 10.1016/j.athoracsur.2010.04.070.

Pompeo E, Tacconi F, Mineo TC. Awake video-assisted thoracoscopic biopsy in complex anterior mediastinal masses. Thorac Surg Clin. 2010 May;20(2):225-33. doi: 10.1016/j.thorsurg.2010.01.003. Review.

Tacconi F, Pompeo E, Sellitri F, Mineo TC. Surgical stress hormones response is reduced after awake videothoracoscopy. Interact Cardiovasc Thorac Surg. 2010 May;10(5):666-71. doi: 10.1510/icvts.2009.224139. Epub 2010 Feb 23.

Tacconi F, Pompeo E, Fabbi E, Mineo TC. Awake video-assisted pleural decortication for empyema thoracis. Eur J Cardiothorac Surg. 2010 Mar;37(3):594-601. doi: 10.1016/j.ejcts.2009.08.003. Epub 2009 Sep 16.

Pompeo E, Mineo TC. Awake operative videothoracoscopic pulmonary resections. Thorac Surg Clin. 2008 Aug;18(3):311-20. doi: 10.1016/j.thorsurg.2008.04.006. Review.

Pompeo E, Mineo TC. Two-year improvement in multidimensional body mass index, airflow obstruction, dyspnea, and exercise capacity index after nonresectional lung volume reduction surgery in awake patients. Ann Thorac Surg. 2007 Dec;84(6):1862-9; discussion 1862-9.

Starting date: November 2007
Last updated: November 8, 2011