An interventional study of Regional anesthesia and analgesia and general anesthesia followed by opioid analgesia in Colon Cancer, sponsored by The Cleveland Clinic. Withdrawn at 3 sites in 3 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2016-09-15.
Sponsored by The Cleveland Clinic · Not applicable, Interventional, and Prevention
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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Exclusion Criteria:
Regional anesthesia and analgesia (either epidural or paravertebral anesthesia).
Procedure: Regional anesthesia and analgesia
Subjects randomized to arm 2 will receive general anesthesia followed by opioid analgesia.
Drug: general anesthesia followed by opioid analgesia
Post-operative analgesia will be epidural bupivacaine and fentanyl as well as intravenous morphine.
sevoflurane general anesthesia and postoperative opioid analgesia
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
Time frame: 5 years
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.
Time frame: days
This study is withdrawn, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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