Regional Anesthesia in Colon Rectal Surgery

Study Overview
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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.

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.

Official Title
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Regional Anesthesia in Patients Undergoing Colon-Rectal Surgery

Conditions
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Colon Cancer

Intervention / Treatment
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* Procedure: Regional anesthesia and analgesia
* Drug: general anesthesia followed by opioid analgesia


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Regional anesthesia and analgesia<br>Regional anesthesia and analgesia (either epidural or paravertebral anesthesia). | Procedure: Regional anesthesia and analgesia<br>* Post-operative analgesia will be epidural bupivacaine and fentanyl as well as intravenous morphine.<br>|
| Active Comparator: general anesthesia followed by opioid analgesia<br>Subjects randomized to arm 2 will receive general anesthesia followed by opioid analgesia. | Drug: general anesthesia followed by opioid analgesia<br>* sevoflurane general anesthesia and postoperative opioid analgesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cancer recurrence | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anesthesia; regional, Cancer recurrence, Anesthesia; inhalational, Analgesia; opioid