The Effect of Epidural Fentanyl on Immune Function
Status:
Unknown status
Trial end date:
2014-12-01
Target enrollment:
Participant gender:
Summary
Background: For cancer to grow and metastasize, inflammatory and immunologic conditions in
the host must be favorable. The perioperative period provides inflammatory and immunologic
changes that may be pro-malignant. Anesthetic medications, including the use of opioid
medication, may contribute to these changes.
Hypothesis: The investigators hypothesize that perioperative immunologic changes in patients
undergoing resection of hepatic colorectal cancer recurrence, as measured by natural killer
cell function and cytokine levels, will undergo less alterations in those who receive only
epidural bupivacaine, as compared to those who receive epidural bupivacaine and fentanyl.
Methods: In this double blind control trial patients with no extra-hepatic evidence of
cancer, undergoing a planned curative resection of hepatic recurrence of colorectal cancer,
will be randomized to receive an epidural with bupivacaine and fentanyl, or bupivacaine
alone. No other perioperative opioid medication will be given, and post-operative analgesia
will be supplemented with acetaminophen and gabapentin. Blood samples and pain ratings using
a verbal analogue scale will be obtained preoperatively, immediately and 6 hours
postoperatively, and then daily until removal of the epidural catheter. Samples will be
analyzed for levels of interleukin 2, 6, 8, 10, 12, 16, 17,TNF-α, TGF α and β, MCP-1, CRP,
and NK cell activity. Cytokines will be measured using a suspension bead array immunoassay
kit, and NK activity will be measured using flow cytometry of isolated peripheral blood
mononuclear cells exposed to the K562 cell line and treated with fluorescent antibodies to
intracellular markers of activation. Data will be compared between groups using t-tests, or
Mann-Whitney tests as appropriate. To demonstrate a 50% smaller decrease of NK cell activity
in the bupivacaine group as compared to the bupivacaine and fentanyl group the investigators
will need to randomize a total of 30 patients.
Phase:
N/A
Details
Lead Sponsor:
McGill University Health Center McGill University Health Centre/Research Institute of the McGill University Health Centre