The Effect of Adding Intraoperative Regional Anesthesia on Cancer Recurrence in Patients Undergoing Lung Cancer Resection

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2011 by Outcomes Research Consortium
Sponsor:
Information provided by:
Outcomes Research Consortium
ClinicalTrials.gov Identifier:
NCT01179308
First received: August 10, 2010
Last updated: August 18, 2011
Last verified: August 2011

August 10, 2010
August 18, 2011
August 2010
August 2013   (final data collection date for primary outcome measure)
disease-free survival [ Time Frame: up to 5 years after surgery ] [ Designated as safety issue: No ]
The effect of regional versus general anesthesia on the primary outcome of disease-free survival (time to the earlier or recurrence or death from any cause)
Same as current
Complete list of historical versions of study NCT01179308 on ClinicalTrials.gov Archive Site
  • NK cell function [ Time Frame: up to three years post procedure ] [ Designated as safety issue: No ]
    Secondary outcomes measured at repeated perioperative time points, include NK cell function, immune-function markers (cytokines, cortisol) and pain.
  • Immune function markers [ Time Frame: for up to 3 years post procedure ] [ Designated as safety issue: No ]
    Secondary outcomes measured at repeated perioperative time points, include NK cell function, immune-function markers (cytokines, cortisol) and pain.
  • Pain [ Time Frame: up to 3 years post proceudure ] [ Designated as safety issue: No ]
    Secondary outcomes measured at repeated perioperative time points, include NK cell function, immune-function markers (cytokines, cortisol) and pain.
Same as current
Not Provided
Not Provided
 
The Effect of Adding Intraoperative Regional Anesthesia on Cancer Recurrence in Patients Undergoing Lung Cancer Resection
The Effect of Adding Intraoperative Regional Anesthesia on Cancer Recurrence in Patients Undergoing Lung Cancer Resection

Surgery is the primary treatment of lung cancer, but surgery releases tumor cells into the systemic circulation. Whether this minimal residual disease results in clinical metastases is a function of host defense. At least three perioperative factors shift the balance toward initiation and progression of minimal residual disease. (1) Surgery per se depresses cell-mediated immunity, reduces concentrations of tumor-related anti-angiogenic factors (e.g., angiostatin and endostatin), and increases concentrations of pro-angiogenic factors such as VEGF. (2) Anesthesia impairs numerous immune functions, including neutrophil, macrophages, dendritic cells, T lymphocytes (T-cell), and Natural killer cell (NK-cell) functions. (3) Opioid analgesics inhibit both cellular and humoral immune function in humans, and promote tumor growth in rodents. Regional analgesia attenuates each of these adverse effects. For example, regional anesthesia largely prevents the neuroendocrine stress response to surgery by blocking afferent neural transmission. With combined regional and general anesthesia/analgesia, the amount of general anesthetic required is much reduced — as is, presumably, immune suppression. And finally, regional analgesia provides superb pain relief, essentially obliterating the need for postoperative opioids. Animal studies show that regional anesthesia improves natural kill cell function and reduces the metastatic burden in animals inoculated with carcinoma cells. Preliminary retrospective data in cancer patients showed, that paravertebral analgesia for breast cancer surgery reduced risk of recurrence or metastasis by 40% during a 2.5 to 4-year follow-up period.

The investigators thus propose to evaluate the effect of combined epidural-general anesthesia compared to general anesthesia on cancer recurrence semi-annually over a period of 5 years.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Lung Cancer
  • Other: General-epidural anesthesia and analgesia
    General anesthesia will be induced with 1-3 µg/kg fentanyl (to a maximum of 150 µg) and 2-4 mg/kg propofol. Tracheal intubation will be facilitated by succinylcholine or a non-depolarizing muscle relaxant. Anesthesia will be maintained with sevoflurane in (80%-100%) oxygen, balance nitrogen, and fentanyl (0.5-1 µg/kg). The lungs will be mechanically ventilated to maintain end-tidal PCO2 near 40 mmHg. Normothermia — a distal esophageal temperature of 36°C — will be maintained with forced-air warming.
  • Other: Balanced general anesthesia and postoperative opioids
    Patients will be pre-medicated with 0-3 mg IV midazolam and/or 0-2 μg/kg IV fentanyl. Prophylactic antibiotics will be given per surgical routine. An epidural catheter will be positioned at T4-T8 level before induction of anesthesia.
  • Active Comparator: General-epidural anesthesia and analgesia
    General anesthesia will be induced with 1-3 µg/kg fentanyl (to a maximum of 150 µg) and 2-4 mg/kg propofol. Tracheal intubation will be facilitated by succinylcholine or a non-depolarizing muscle relaxant. Anesthesia will be maintained with sevoflurane in (80%-100%) oxygen, balance nitrogen, and fentanyl (0.5-1 µg/kg). The lungs will be mechanically ventilated to maintain end-tidal PCO2 near 40 mmHg. Normothermia — a distal esophageal temperature of 36°C — will be maintained with forced-air warming.
    Intervention: Other: General-epidural anesthesia and analgesia
  • Active Comparator: Balanced general anesthesia and postoperative opioids
    Patients will be pre-medicated with 0-3 mg IV midazolam and/or 0-2 μg/kg IV fentanyl. Prophylactic antibiotics will be given per surgical routine. An epidural catheter will be positioned at T4-T8 level before induction of anesthesia.
    Intervention: Other: Balanced general anesthesia and postoperative opioids
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1532
August 2018
August 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Primary non-small cell lung cancer (stage 1-3) as determined according to the IASLC Lung Cancer Staging Project;
  • Scheduled for potentially curative tumor resection;
  • Written informed consent, including willingness to be randomized to epidural anesthesia/analgesia plus general anesthesia or to general anesthesia and postoperative opioid analgesia.

Exclusion Criteria:

  • Any contraindication to epidural anesthesia, (including coagulopathy, abnormal anatomy).
  • Any contraindication to midazolam, propofol, sevoflurane, fentanyl, morphine, or hydromorphone.
  • Age < 18 or > 85 years old.
  • Other cancer not believed by the attending surgeon to be in long-term remission.
Both
18 Years to 85 Years
No
Contact: Andrea Kurz, M.D. 216-445-9924 ak@or.org
Contact: Gretchen Upton 216-444-3289 uptong@ccf.org
United States
 
NCT01179308
10-610
No
Andrea Kurz, MD, Cleveland Clinic
Outcomes Research Consortium
Not Provided
Principal Investigator: Andrea Kurz, M.D. The Cleveland Clinic
Outcomes Research Consortium
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP