Clinical Trial: Epidural Anesthesia/Analgesia and Outcome of Patients After Lung Cancer Surgery

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Effects of Epidural Anesthesia/Analgesia on Recurrence and Metastasis in Patients After Lung Cancer Surgery: A Randomized Controlled Trial

Brief Summary: Some studies suggest that regional anesthesia/analgesia may decrease the rate of recurrence/metastasis in patients after cancer surgery. However, evidences from prospective studies are still lacking. The purpose of this randomized controlled trial is to investigate the effect of epidural anesthesia/analgesia on the rate of recurrence/metastasis in patients undergoing lung cancer surgery.

Detailed Summary:

Lung cancer is rapidly increasing and is a primary cause of cancer deaths. Surgical resection is the first line of treatment for lung cancer. However, it is unavoidable that some tumor cells will be disseminated into the blood or the lymphatic systems during surgery. The outcome depends on the balance between tumor-promoting factors and immune function of the body during the perioperative period.

Studies showed that stress response induced by surgery inhibits the cell-mediated immunity. In addition, anesthesia management during perioperative period can all affect the immune function of patients; for example, volatile anesthetics and opioids might aggravate the immunosuppression and potentially worsen long-term outcome, whereas regional anesthesia might attenuate the immunosuppression and exert protective effects. However, existing evidences are insufficient to draw conclusion in this topic.

The investigators hypothesize that regional anesthesia might improve long-term outcome in patients after lung cancer surgery, possibly by preserving postoperative immune function. The purpose of this randomized controlled trial is to investigate the effect of epidural anesthesia/analgesia on the rate of recurrence/metastasis in patients undergoing lung cancer surgery.


Sponsor: Peking University First Hospital

Current Primary Outcome: 2-year rate of recurrence and/or metastasis [ Time Frame: At 2 years after surgery ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Postoperative pain score [ Time Frame: During the first 3 days after surgery ]
    Assessed with numeric rating score where 0 = no pain and 10 = the most severe pain
  • Incidence of postoperative complications [ Time Frame: During the first 30 days after surgery ]
  • Length of stay in hospital after surgery [ Time Frame: From end of surgery to 30 days after surgery ]
  • All-cause 30-day mortality [ Time Frame: At 30 days after surgery ]
  • 1-year tumor-free survival rate [ Time Frame: At 1 year after surgery ]
  • 2-year tumor-free survival rate [ Time Frame: At 2 years after surgery ]
  • 1-year overall survival rate [ Time Frame: At 1 year after surgery ]
  • 2-year overall survival rate [ Time Frame: At 2 years after surgery ]


Original Secondary Outcome: Same as current

Information By: Peking University First Hospital

Dates:
Date Received: June 12, 2016
Date Started: January 2014
Date Completion: November 2019
Last Updated: January 2, 2017
Last Verified: January 2017