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


N/A
18 Years
85 Years
Open (Enrolling)
Both
Lung Cancer

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Outcome Measure:

disease-free survival

Outcome Description:

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)

Outcome Time Frame:

up to 5 years after surgery

Safety Issue:

No

Principal Investigator

Andrea Kurz, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Cleveland Clinic

Authority:

United States: Institutional Review Board

Study ID:

10-610

NCT ID:

NCT01179308

Start Date:

August 2010

Completion Date:

August 2018

Related Keywords:

  • Lung Cancer
  • regional analgesia
  • routine general anesthesia
  • immune system response
  • lung cancer (stage 1-3)
  • Lung Neoplasms
  • Recurrence

Name

Location

Cleveland ClinicCleveland, Ohio  44195