Regional Anesthesia in Colon Rectal Surgery
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ClinicalTrials.gov Identifier: NCT00684229 |
Recruitment Status
:
Withdrawn
(investigator could not identify any patients)
First Posted
: May 26, 2008
Last Update Posted
: September 15, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Colon Cancer | Procedure: Regional anesthesia and analgesia Drug: general anesthesia followed by opioid analgesia | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Prevention |
Official Title: | Regional Anesthesia in Patients Undergoing Colon-Rectal Surgery |
Study Start Date : | December 2007 |
Actual Primary Completion Date : | November 2013 |
Actual Study Completion Date : | November 2013 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Regional anesthesia and analgesia
Regional anesthesia and analgesia (either epidural or paravertebral anesthesia).
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Procedure: Regional anesthesia and analgesia
Post-operative analgesia will be epidural bupivacaine and fentanyl as well as intravenous morphine.
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Active Comparator: general anesthesia followed by opioid analgesia
Subjects randomized to arm 2 will receive general anesthesia followed by opioid analgesia.
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Drug: general anesthesia followed by opioid analgesia
sevoflurane general anesthesia and postoperative opioid analgesia
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- 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.

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Ages Eligible for Study: | 18 Years to 85 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Primary colon cancer without known extension beyond colon (T3, N0, M0)
- Scheduled for open, laparoscopic assisted and laparoscopic resection of the colon.
- Written informed consent, including willingness to be randomized to epidural anesthesia/analgesia or to sevoflurane general anesthesia and postoperative opioid analgesia.
Exclusion Criteria:
- Previous surgery for colon cancer;
- Any contraindication to epidural anesthesia or analgesia (including coagulopathy, abnormal anatomy);
- Any contraindication to midazolam, propofol, sevoflurane, fentanyl, or morphine;
- Age <18 or >85 years old;
- ASA Physical Status ≥4;
- Other cancer not believed by the attending surgeon to be in long-term remission;
- Systemic disease believed by the attending surgeon or anesthesiologist to present ≥25% two-year mortality.

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 Clinic | |
Cleveland, Ohio, United States, 44195 | |
Argentina | |
Hospital Italiano de Buenos Aires | |
Buenos Aires, Argentina | |
Germany | |
University of Dusseldorf | |
Dusseldorf, Germany, 101007 |
Study Chair: | Daniel I Sessler, MD | The Cleveland Clinic | |
Principal Investigator: | Andrea Kurz, MD | The Cleveland Clinic |
Responsible Party: | Andrea Kurz, Principal Investigator, The Cleveland Clinic |
ClinicalTrials.gov Identifier: | NCT00684229 History of Changes |
Other Study ID Numbers: |
07-933 |
First Posted: | May 26, 2008 Key Record Dates |
Last Update Posted: | September 15, 2016 |
Last Verified: | September 2016 |
Keywords provided by Andrea Kurz, The Cleveland Clinic:
Anesthesia; regional Cancer recurrence Anesthesia; inhalational Analgesia; opioid |
Additional relevant MeSH terms:
Anesthetics Analgesics, Opioid Central Nervous System Depressants Physiological Effects of Drugs |
Narcotics Analgesics Sensory System Agents Peripheral Nervous System Agents |