Regional Anesthesia in Colon Rectal Surgery

This study has been withdrawn prior to enrollment.

(investigator could not identify any patients)

Sponsor:

Information provided by (Responsible Party):

Andrea Kurz, The Cleveland Clinic

ClinicalTrials.gov Identifier:

NCT00684229

First received: May 22, 2008

Last updated: September 13, 2016

Last verified: September 2016

History of Changes

Purpose

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.

Condition	Intervention
Colon Cancer	Procedure: Regional anesthesia and analgesia Drug: general anesthesia followed by opioid analgesia


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Investigator) Primary Purpose: Prevention
Official Title:	Regional Anesthesia in Patients Undergoing Colon-Rectal Surgery

Resource links provided by NLM:

MedlinePlus related topics: Anesthesia

U.S. FDA Resources

Further study details as provided by Andrea Kurz, The Cleveland Clinic:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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.


Enrollment:	0
Study Start Date:	December 2007
Study Completion Date:	November 2013
Primary Completion Date:	November 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Detailed Description:

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.

Eligibility


Ages Eligible for Study:	18 Years to 85 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00684229

Locations


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

Sponsors and Collaborators

The Cleveland Clinic

Investigators


Study Chair:	Daniel I Sessler, MD	The Cleveland Clinic
Principal Investigator:	Andrea Kurz, MD	The Cleveland Clinic

More Information


Responsible Party:	Andrea Kurz, Principal Investigator, The Cleveland Clinic
ClinicalTrials.gov Identifier:	NCT00684229 History of Changes
Other Study ID Numbers:	07-933
Study First Received:	May 22, 2008
Last Updated:	September 13, 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

ClinicalTrials.gov processed this record on July 21, 2017

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