Regional Anesthesia in Colon Rectal Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2013-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Colon Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Regional anesthesia and analgesia

Regional anesthesia and analgesia (either epidural or paravertebral anesthesia).

Group Type ACTIVE_COMPARATOR

Regional anesthesia and analgesia

Intervention Type PROCEDURE

Post-operative analgesia will be epidural bupivacaine and fentanyl as well as intravenous morphine.

general anesthesia followed by opioid analgesia

Subjects randomized to arm 2 will receive general anesthesia followed by opioid analgesia.

Group Type ACTIVE_COMPARATOR

general anesthesia followed by opioid analgesia

Intervention Type DRUG

sevoflurane general anesthesia and postoperative opioid analgesia

Interventions

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Regional anesthesia and analgesia

Post-operative analgesia will be epidural bupivacaine and fentanyl as well as intravenous morphine.

Intervention Type PROCEDURE

general anesthesia followed by opioid analgesia

sevoflurane general anesthesia and postoperative opioid analgesia

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No