Overview

Comparing the Outcome of Two Intraoperative Analgesia Techniques After Hepato-pancreato-biliary Surgery

Status:
Unknown status
Trial end date:
2012-01-01
Target enrollment:
0
Participant gender:
All
Summary
Inadequate pain control after abdominal procedures may lead to adverse postoperative outcome. Epidural analgesia is currently an accepted technique in abdominal surgery, but its use has been limited in liver resections by postoperative coagulation disturbances and the possible increased risk of bleeding complications, including spinal hematoma. A range of alternative analgesic techniques can be used for major liver or pancreatic resections, including intrathecal morphine (single shot) administered immediately before surgery, and continuous administration of intravenous (IV) short-acting opioids, such as remifentanil, plus a single bolus of IV morphine. Postoperatively analgesia may be obtained by patient-controlled morphine analgesia (IV PCA). Both protocols have been demonstrated to provide satisfactory postoperative pain relief, and each has its unique advantages. However, to this end there is no data in the literature to show benefit from one regimen over the other. We therefore wish to determine whether there is a difference in analgesic efficacy between the two techniques, as optimizing perioperative pain relief in this rapidly expanding surgical field is of utmost importance. Our hypothesis is that continuous intraoperative IV analgesia with remifentanil followed by IV PCA morphine is not inferior to intrathecal morphine with respect to analgesia and ambulation outcome, and may provide an alternative, non-invasive intraoperative analgesic technique.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Tel-Aviv Sourasky Medical Center
Treatments:
Morphine
Remifentanil
Criteria
Inclusion Criteria:

ASA physical status I-III patients (> 18 years old), scheduled for elective liver
resection, pancreatic resection or pancreaticoduodenectomy ("Whipple" procedure) at Tel
Aviv-Sourasky Medical Center.

Exclusion Criteria:

Contraindications to the spinal technique, allergy to the study drugs, patients treated
with opioids for chronic pain, patients with obstructive sleep apnea, morbidly obese
patients, pregnant women, patient requiring mechanical ventilation at the end of surgery.