Overview

This trial is active, not recruiting.

Conditions lung cancer, thoracic surgery, anesthesia, epidural, neoplasm recurrence, local, neoplasm metastasis
Treatments combined epi-ga/pcea, ga/pcia
Sponsor Peking University First Hospital
Start date January 2014
End date November 2017
Trial size 396 participants
Trial identifier NCT02801409, 2013[653]

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Combined epidural-general anesthesia (combined Epi-GA) will be performed during surgery and patient-controlled epidural analgesia (PCEA) will be provided after surgery
combined epi-ga/pcea
Thoracic epidural catheterization will be performed according the surgical incision site. General anesthesia will be induced and maintained as in the control group, combined with epidural anesthesia which will be maintained with 0.5% ropivacaine during surgery. Patient-controlled epidural analgesia (0.12% ropivacaine and 0.5 ug/ml sufentanil) will be provided after surgery.
(Active Comparator)
General anesthesia (GA) will be performed during surgery and patient-controlled intravenous analgesia (PCIA) will be provided after surgery
ga/pcia
General anesthesia will be induced with midazolam, propofol, sufentanil and rocuronium. Anesthesia will be maintained with intravenous (propofol), inhalational (sevoflurane), or combined intravenous-inhalational anesthetics. Opioids and muscle relaxants will be administered when considered necessary. Patient-controlled intravenous analgesia (0.5 mg/ml morphine) will be provided after surgery.

Primary Outcomes

Measure
2-year rate of recurrence and/or metastasis
time frame: At 2 years after surgery

Secondary Outcomes

Measure
Postoperative pain score
time frame: During the first 3 days after surgery
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

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

Inclusion Criteria: 1. age of 18 years or older, but less than 80 years; 2. clinical diagnosis of primary non-small cell lung cancer (stage IA-IIIA), and plan to undergo radical surgery; 3. agree to receive postoperative patient-controlled analgesia; 4. agree to participate in the study and have signed written informed consent. Exclusion Criteria: 1. clinical evidence of metastasis, complicated with primary malignant tumor in other place, or received chemotherapy or radiotherapy before surgery; 2. complicated with mental illness, severe heart disease (NYHA classification >3), renal insufficience (serum creatinine > 442 umol/L or receiving renal replacement therapy), or severe hepatic disease (Child-Pugh classification = C) before surgery; 3. complicated with autoimmune diseases, or receiving glucocorticoids or other immunosuppressants before surgery; 4. contradictions of epidural anesthesia; 5. received surgery and/or anesthesia within one year; 6. allergic to any drugs used during the study.

Additional Information

Official title Effects of Epidural Anesthesia/Analgesia on Recurrence and Metastasis in Patients After Lung Cancer Surgery: A Randomized Controlled Trial
Principal investigator Dong-Xin Wang, MD, PhD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Peking University First Hospital.