Clinical trial NCT01469728: Comparison of Thoracoscopic Talc Pleurodesis by Thoracic Epidural or General Anesthesia
Official title: Randomized Study of Thoracoscopic Talc Pleurodesis Performed by Thoracic Epidural or General Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pleural Effusion
Keywords: VATS
awake thoracic surgery
pleurodesis
talc
TEA
epidural anesthesia
Video-Assisted
Anesthesia Epidural
Lead sponsor: University of Rome Tor Vergata
Sponsor class: OTHER
First posted: 2011-11-10
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Grade of perioperative medical care (PMC).
timeFrame: participants are followed for the duration of hospital stay; average of 5 days
Secondary outcomes:
measure: Postoperative pain
timeFrame: Postoperatively at 3h,12h and 24h
measure: Perioperative changes in blood gases
timeFrame: Imediately before operation, at end-procedure, postoperatively at 1h and 24h
measure: Perioperative changes in cardiocirculatory variables including heart rate (HR) and mean arteial pressure (MAP)
timeFrame: Immediately before the operation, at end-procedure, postoperatively at 1h and 24h
measure: Postoperative changes in spirometric variables
timeFrame: Postoperatively at 3h,12h and 24h
measure: Morbidity
timeFrame: from day of operation to discharge; average, 5 days
measure: Hospital stay
timeFrame: from day of operation to discharge; average, 5 days
measure: Redo pleurodesis
timeFrame: From date of operation until the date of redo pleurodesis or assessed every 6 months or until date of death from any cause
measure: Operative mortality
timeFrame: from day of operation for up to 30 days postoperatively
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Policlinico Tor Vergata University
Study officials:
References:
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.
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.
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.
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.
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.
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.
citation: 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.
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. doi: 10.1016/j.athoracsur.2007.07.007.
citation: Pompeo E, Dauri M; Awake Thoracic Surgery Research Group. Is there any benefit in using awake anesthesia with thoracic epidural in thoracoscopic talc pleurodesis? J Thorac Cardiovasc Surg. 2013 Aug;146(2):495-7.e1. doi: 10.1016/j.jtcvs.2013.03.038. Epub 2013 Apr 17. No abstract available.