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NCT Number: NCT01469728

Comparison of Thoracoscopic Talc Pleurodesis by Thoracic Epidural or General Anesthesia

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.

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Key information

Conditions

Pleural Effusion Pleural Diseases Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Policlinico Tor Vergata University

Rome, 00133, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-awake VATS talc pleurodesis

Procedure

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

Awake VATS talc pleurodesis

Procedure

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

Primary outcomes

  1. Grade of perioperative medical care (PMC).

    Time frame: 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 outcomes

  1. Postoperative pain

    Time frame: Postoperatively at 3h,12h and 24h

  2. Perioperative changes in blood gases

    Time frame: 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)

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

    Time frame: Immediately before the operation, at end-procedure, postoperatively at 1h and 24h

  4. Postoperative changes in spirometric variables

    Time frame: Postoperatively at 3h,12h and 24h

    Forced expiratory volume in one second(FEV1), forced vital capacity (FVC), peak expiratory flow (PEF)

  5. Morbidity

    Time frame: from day of operation to discharge; average, 5 days

  6. Hospital stay

    Time frame: from day of operation to discharge; average, 5 days

  7. Redo pleurodesis

    Time frame: 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

  8. Operative mortality

    Time frame: from day of operation for up to 30 days postoperatively

Sponsors and collaborators

Lead sponsor

University of Rome Tor Vergata

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Nov 10, 2011
Registry last updated
Nov 10, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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