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| Name | Class |
|---|---|
| Shanghai Chest Hospital | OTHER |
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The primary hypothesis is that disease-free survival is improved in patients undergoing resection for tumor thought to be stage I-III primary non-small cell lung cancer in patients with combined general-epidural anesthesia & analgesia as compared to patients receiving general anesthesia and postoperative patient-controlled opioid analgesia. Patients having surgery for resection of potentially curable lung cancer will be randomized to combined general and epidural anesthesia or general anesthesia with opioid analgesia. The primary outcome will be disease-free survival.
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.
The primary hypothesis is that disease-free survival is improved in patients undergoing resection for tumor thought to be stage I-III primary non-small cell lung cancer in patients with combined general-epidural anesthesia & analgesia as compared to patients receiving general anesthesia and postoperative patient-controlled opioid analgesia. Patients having surgery for resection of potentially curable lung cancer will be randomized to combined general and epidural anesthesia or general anesthesia with opioid analgesia. The primary outcome will be disease-free survival.
The effect of combined epidural/general anesthesia versus general anesthesia with opioid analgesia on the primary outcome of disease-free survival (time to the earlier or recurrence or death from any cause) will be assessed uni-variably with Kaplan-Meier analyses and multivariably (primary analysis) with a Cox proportional hazards regression model adjusting for known risk factors for recurrence, including tumor stage, size of tumor, age, sex, receipt of chemotherapy before or after surgery, and clinical site. As usual for this type of analysis, stopping criteria will be based on number of outcome events rather than enrollment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combined general/epidural anesthesia | Experimental | Combined general/epidural anesthesia and analgesia. General anesthesia may include propofol, isoflurane, sevoflurane, and other drugs. Epidural anesthesia will include bupivacaine and other local anesthetics. |
|
| General anesthesia with opioid analgesia | Experimental | General anesthesia with routine drugs and intravenous PCA opioid analgesia. General anesthesia may include propofol, isoflurane, sevoflurane, and other drugs. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| General anesthesia with opioid analgesia | Procedure | General anesthesia with routine drugs and intravenous patient controlled opioid analgesia. General anesthesia may include propofol, isoflurane, sevoflurane, and other drugs. |
| Measure | Description | Time Frame |
|---|---|---|
| Cancer-free survival | Patients who remain alive without known lung cancer recurrence | 3 years or as available |
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity | Time-weighted average pain scores over initial two days of hospitalization. | 2 days |
| SF-12 Health Survey | 6, 12, 24, and 36 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel I Sessler, MD | The Cleveland Clinic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Chest Hospital | Shanghai | China |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D000768 | Anesthesia, General |
| D000767 | Anesthesia, Epidural |
| ID | Term |
|---|---|
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
| D000765 | Anesthesia, Conduction |
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| Combined general/epidural anesthesia | Procedure | Combined general/epidural anesthesia and analgesia. General anesthesia may include propofol, isoflurane, sevoflurane, and other drugs. Epidural anesthesia will include bupivacaine and other local anesthetics. |
|
| McGill Pain Questionnaire | 6, 12, 24, and 36 months |
| Neuropathic Pain Questionnaire | 6, 12, 24, and 36 months |
| Opioid use | Total opioid use | 2 days |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |