The Effect of Epidural Fentanyl on Immune Function
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Malignancy |
Drug: epidural fentanyl |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Basic Science |
| Official Title: | The Effect of Perioperative Epidural Opioids on Inflammatory Cytokines and Immune Function |
- Natural Killer cell activity. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
- Visual analogue pain scores [ Time Frame: 4days ] [ Designated as safety issue: No ]
- opioid side effects [ Time Frame: 4 days ] [ Designated as safety issue: No ]
- incidence of infections [ Time Frame: 1 week ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Epidural bupivacaine |
Drug: epidural fentanyl
withold epidural fentanyl
|
| Active Comparator: Epidural bupivacaine and fentanyl |
Drug: epidural fentanyl
withold epidural fentanyl
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
We will consider for inclusion any adult patient undergoing a planned curative hepatic resection of a colorectal carcinoma liver recurrence.
Exclusion Criteria:
E 3. Patients Excluded Any patient unable to communicate in English or French. Any patient with evidence of extra-hepatic metastasis. Any patient with contra-indications to epidural anesthesia, or any of the medications used in the study.
Any patient with evidence of coronary artery disease or congestive heart failure, either previously or currently.
Any patient with insulin treated diabetes. Any patient with a BMI greater than 40. Any patient who has received steroids in the past 2 months. Any patient who has taken any pain medication the week before surgery. Any pregnant or breast feeding patient. Any patient with a chronic inflammatory disease, including but not limited to Lupus, rheumatoid arthritis, and inflammatory bowel disease.
Contacts and Locations| Contact: Albert Moore | 514-934-1934 ext 34880 | moore_albert@hotmail.com |
| Canada, Quebec | |
| Royal Victoria Hospital | Recruiting |
| Montreal, Quebec, Canada, H3A 1A1 | |
| Contact: Albert Moore moore_albert@hotmail.com | |
More Information
No publications provided
| Responsible Party: | Albert Moore, Assistant Professor, McGill University Health Center |
| ClinicalTrials.gov Identifier: | NCT01646775 History of Changes |
| Other Study ID Numbers: | 11-186-SDR |
| Study First Received: | July 11, 2012 |
| Last Updated: | February 13, 2013 |
| Health Authority: | Canada: Health Canada |
Keywords provided by McGill University Health Center:
|
opioid malignancy epidural |
Additional relevant MeSH terms:
|
Neoplasms Fentanyl Analgesics, Opioid Adjuvants, Anesthesia Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Narcotics |
Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Anesthetics, Intravenous Anesthetics, General Anesthetics |
ClinicalTrials.gov processed this record on May 16, 2013