Regional Anesthesia in Colon Rectal Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00684229|
Recruitment Status : Withdrawn (investigator could not identify any patients)
First Posted : May 26, 2008
Last Update Posted : September 15, 2016
|Condition or disease||Intervention/treatment|
|Colon Cancer||Procedure: Regional anesthesia and analgesia Drug: general anesthesia followed by opioid analgesia|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Regional Anesthesia in Patients Undergoing Colon-Rectal Surgery|
|Study Start Date :||December 2007|
|Primary Completion Date :||November 2013|
|Study Completion Date :||November 2013|
Active Comparator: Regional anesthesia and analgesia
Regional anesthesia and analgesia (either epidural or paravertebral anesthesia).
Procedure: Regional anesthesia and analgesia
Post-operative analgesia will be epidural bupivacaine and fentanyl as well as intravenous morphine.
Active Comparator: general anesthesia followed by opioid analgesia
Subjects randomized to arm 2 will receive general anesthesia followed by opioid analgesia.
Drug: general anesthesia followed by opioid analgesia
sevoflurane general anesthesia and postoperative opioid analgesia
- cancer recurrence [ Time Frame: 5 years ]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
- length of post operative hospitalization [ Time Frame: days ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00684229
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|Hospital Italiano de Buenos Aires|
|Buenos Aires, Argentina|
|University of Dusseldorf|
|Dusseldorf, Germany, 101007|
|Study Chair:||Daniel I Sessler, MD||The Cleveland Clinic|
|Principal Investigator:||Andrea Kurz, MD||The Cleveland Clinic|