Comparison of Thoracoscopic Talc Pleurodesis by Thoracic Epidural or General Anesthesia

Pleural Effusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01469728
• Other study ID #: 107/07
• Secondary ID: #20112
• Status: Completed
• Phase: Phase 2
• First received: October 28, 2011
• Last updated: November 8, 2011
• Start date: November 2007
• Est. completion date: November 2010

Study information

• Verified date: November 2011
• Source: University of Rome Tor Vergata
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

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

Related Conditions & MeSH terms

• Pleural Effusion

Intervention

Procedure:
• Non-awake VATS talc pleurodesis
Thoracoscopic talc pleurodesis performed through sole general anesthesia and one-lung ventilation
• Awake VATS talc pleurodesis
Thoracoscopic talc pleurodesis performed in awake patients through sole thoracic epidural anesthesia.

Locations

Country	Name	City	State
Italy	Policlinico Tor Vergata University	Rome

Sponsors (1)

Lead Sponsor	Collaborator
University of Rome Tor Vergata

Country where clinical trial is conducted

Italy, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Postoperative pain		Postoperatively at 3h,12h and 24h	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Morbidity		from day of operation to discharge; average, 5 days	Yes
Secondary	Hospital stay		from day of operation to discharge; average, 5 days	No
Secondary	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	No
Secondary	Operative mortality		from day of operation for up to 30 days postoperatively	Yes