Regional Anesthesia in Colon Rectal Surgery

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease	Intervention/treatment	Phase
Colon Cancer	Procedure: Regional anesthesia and analgesia; Drug: general anesthesia followed by opioid analgesia	Not Applicable

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.

Study Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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 :

1. 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.

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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