Regional Anesthesia in Colon Rectal Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2012 by Outcomes Research Consortium
Sponsor:
Information provided by:
Outcomes Research Consortium
ClinicalTrials.gov Identifier:
NCT00684229
First received: May 22, 2008
Last updated: May 8, 2012
Last verified: May 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Regional Anesthesia in Patients Undergoing Colon-Rectal Surgery

Resource links provided by NLM:


Further study details as provided by Outcomes Research Consortium:

Primary Outcome Measures:
  • cancer recurrence [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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: as measured in days ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 2500
Study Start Date: December 2007
Estimated Study Completion Date: December 2022
Estimated Primary Completion Date: December 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
Genders Eligible for Study:   Both
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

Contacts
Contact: Gretchen Upton, BA 216-444-3289 uptong@ccf.org

Locations
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Gretchen Upton, BA    216-444-6135    uptong@ccf.org   
Principal Investigator: Andrea Kurz, MD         
Argentina
Hospital Italiano de Buenos Aires Recruiting
Buenos Aires, Argentina
Contact: Adrian Alvarez, MD       tatotatun@gmail.com   
Contact: Susana Perez, MD    (5411)4959-0200 ext 9812    susanagabrielaperez@gmail.com   
Principal Investigator: Adrian Alvarez, MD         
Germany
University of Dusseldorf Recruiting
Dusseldorf, Germany, 101007
Contact: Tanja Meyer-Treschan, MD    49 (0) 211 81 17491    'Tanja.Treschan@med.uni-duesseldorf.de'   
Principal Investigator: Tanja Meyer-Treschan, MD         
Sponsors and Collaborators
Outcomes Research Consortium
Investigators
Study Chair: Daniel I Sessler, MD The Cleveland Clinic
Principal Investigator: Andrea Kurz, MD The Cleveland Clinic
  More Information

No publications provided

Responsible Party: Andrea Kurz, MD, Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00684229     History of Changes
Other Study ID Numbers: 07-933
Study First Received: May 22, 2008
Last Updated: May 8, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Outcomes Research Consortium:
Anesthesia; regional
Cancer recurrence
Anesthesia; inhalational
Analgesia; opioid

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Anesthetics
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on August 25, 2014