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This study will compare recurrence rates in patients with colorectal cancer who will be randomly assigned to epidural anesthesia/analgesia combined with general anesthesia or to general anesthesia followed by opioid analgesia.
The study population will consist of patients who are scheduled for open laparoscopic or laparoscopic assisted surgery for colon cancer. Patients will randomized into one of two groups. The intervention group will receive combined regional and general anesthesia during surgery. Postoperative pain treatment will be based on regional anesthesia techniques. The Control group will receive general anesthesia during surgery. Postoperative pain treatment will be based primarily on opioids. After surgery, patients will be followed daily during their hospital stay. Patients will be contacted by telephone every 6 months for five years. Quality of life questionnaires will be administered at these follow ups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regional anesthesia and analgesia | Active Comparator | Regional anesthesia and analgesia (either epidural or paravertebral anesthesia). |
|
| general anesthesia followed by opioid analgesia | Active Comparator | Subjects randomized to arm 2 will receive general anesthesia followed by opioid analgesia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regional anesthesia and analgesia | Procedure | Post-operative analgesia will be epidural bupivacaine and fentanyl as well as intravenous morphine. |
|
| Measure | Description | Time Frame |
|---|---|---|
| cancer recurrence | To determine if recurrence of local/metastatic cancer after open and laparoscopic resection colon cancers is lower in patients randomized to epidural anesthesia & analgesia than to sevoflurane general anesthesia and postoperative opioid analgesia | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| length of post operative hospitalization | To determine if the length of post operative hospitalization is shortened in patients randomized to epidural anesthesia & analgesia than to sevoflurane general anesthesia and postoperative opioid analgesia. | days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel I Sessler, MD | The Cleveland Clinic | Study Chair |
| Andrea Kurz, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States | ||
| Hospital Italiano de Buenos Aires |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| ID | Term |
|---|---|
| D000765 | Anesthesia, Conduction |
| D000698 | Analgesia |
| ID | Term |
|---|---|
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
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| general anesthesia followed by opioid analgesia | Drug | sevoflurane general anesthesia and postoperative opioid analgesia |
|
| Buenos Aires |
| Argentina |
| University of Dusseldorf | Düsseldorf | 101007 | Germany |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |