Regional Anesthesia in Colon Rectal Surgery

Not Applicable

Withdrawn

• Conditions: Colon Cancer
• Interventions: Procedure: Regional anesthesia and analgesia; Drug: general anesthesia followed by opioid analgesia

• Registration Number: NCT00684229
• Lead Sponsor: The Cleveland Clinic

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.

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 Timeline

• Study Start: 2007-12
• Study First Submitted: 2008-05-22
• Study First Submitted QC: 2008-05-22
• Study First Posted: 2008-05-26
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-13
• Last Update Posted: 2016-09-15

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Regional anesthesia and analgesia	Regional anesthesia and analgesia	Regional anesthesia and analgesia (either epidural or paravertebral anesthesia).
general anesthesia followed by opioid analgesia	general anesthesia followed by opioid analgesia	Subjects randomized to arm 2 will receive general anesthesia followed by opioid analgesia.

Primary Outcome Measures

Name	Time	Method
cancer recurrence	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

Name	Time	Method
length of post operative hospitalization	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.

Trial Locations

Locations (3)

Hospital Italiano de Buenos Aires; 🇦🇷 Buenos Aires, Argentina

University of Dusseldorf; 🇩🇪 Dusseldorf, Germany

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States