Regional Anesthesia in Colon Rectal Surgery

NeuroTherapia, Inc.

Status: Withdrawn

Conditions: Colon Cancer

Treatments: Procedure: Regional anesthesia and analgesia; Drug: general anesthesia followed by opioid analgesia

Study type: Interventional

Funder types: Other

Identifiers

NCT00684229

07-933

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

Regional anesthesia and analgesia

Active Comparator group

Description:

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

Treatment:

Procedure: Regional anesthesia and analgesia

general anesthesia followed by opioid analgesia

Active Comparator group

Description:

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

Treatment:

Drug: general anesthesia followed by opioid analgesia