The Effect of Epidural Fentanyl on Immune Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01646775
Recruitment Status : Unknown
Verified June 2014 by Albert Moore, McGill University Health Center.
Recruitment status was:  Recruiting
First Posted : July 20, 2012
Last Update Posted : June 23, 2014
Information provided by (Responsible Party):
Albert Moore, McGill University Health Center

Brief 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.

Condition or disease Intervention/treatment Phase
Malignancy Drug: epidural fentanyl Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Effect of Perioperative Epidural Opioids on Inflammatory Cytokines and Immune Function
Study Start Date : July 2012
Estimated Primary Completion Date : October 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Epidural bupivacaine Drug: epidural fentanyl
withold epidural fentanyl

Active Comparator: Epidural bupivacaine and fentanyl Drug: epidural fentanyl
withold epidural fentanyl

Primary Outcome Measures :
  1. Natural Killer cell activity. [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. Visual analogue pain scores [ Time Frame: 4days ]
  2. opioid side effects [ Time Frame: 4 days ]
  3. incidence of infections [ Time Frame: 1 week ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01646775

Contact: Albert Moore 514-934-1934 ext 34880

Canada, Quebec
Royal Victoria Hospital Recruiting
Montreal, Quebec, Canada, H3A 1A1
Contact: Albert Moore   
Sponsors and Collaborators
McGill University Health Center
Principal Investigator: Albert Moore, MD McGill University Health Center

Responsible Party: Albert Moore, Assistant Professor, McGill University Health Center Identifier: NCT01646775     History of Changes
Other Study ID Numbers: 11-186-SDR
First Posted: July 20, 2012    Key Record Dates
Last Update Posted: June 23, 2014
Last Verified: June 2014

Keywords provided by Albert Moore, McGill University Health Center:

Additional relevant MeSH terms:
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General