Regional Anesthesia in Colon Rectal Surgery

September 13, 2016 updated by: Andrea Kurz, The Cleveland Clinic

Regional Anesthesia in Patients Undergoing Colon-Rectal Surgery

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Hospital Italiano de Buenos Aires
  • Germany
      • Dusseldorf, Germany, 101007
        • University of Dusseldorf
  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (ACTUAL)

November 1, 2013

Study Completion (ACTUAL)

November 1, 2013

Study Registration Dates

First Submitted

May 22, 2008

First Submitted That Met QC Criteria

May 22, 2008

First Posted (ESTIMATE)

May 26, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

September 15, 2016

Last Update Submitted That Met QC Criteria

September 13, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-933

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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