The Effect of Epidural Fentanyl on Immune Function

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre (Other)

Overall Status

Unknown status

CT.gov ID

NCT01646775

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

Anticipated 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 :

Jul 1, 2012

Anticipated Primary Completion Date :

Oct 1, 2014

Anticipated Study Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Epidural bupivacaine	Drug: epidural fentanyl withold epidural fentanyl
Active Comparator: Epidural bupivacaine and fentanyl	Drug: epidural fentanyl withold epidural fentanyl

Arm

Intervention/Treatment

Experimental: Epidural bupivacaine

Drug: epidural fentanyl

withold epidural fentanyl

Active Comparator: Epidural bupivacaine and fentanyl

Drug: epidural fentanyl

withold epidural fentanyl

Outcome Measures

Primary Outcome Measures

Natural Killer cell activity. [24 hours]

Secondary Outcome Measures

Visual analogue pain scores [4days]
opioid side effects [4 days]
incidence of infections [1 week]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Royal Victoria Hospital	Montreal	Quebec	Canada	H3A 1A1

Sponsors and Collaborators

McGill University Health Centre/Research Institute of the McGill University Health Centre

Investigators

Principal Investigator: Albert Moore, MD, McGill University Health Centre/Research Institute of the McGill University Health Centre

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Albert Moore, Assistant Professor, McGill University Health Centre/Research Institute of the McGill University Health Centre

ClinicalTrials.gov Identifier:

NCT01646775

Other Study ID Numbers:

11-186-SDR

First Posted:

Jul 20, 2012

Last Update Posted:

Jun 23, 2014

Last Verified:

Jun 1, 2014

Keywords provided by Albert Moore, Assistant Professor, McGill University Health Centre/Research Institute of the McGill University Health Centre

opioid

malignancy

epidural

Additional relevant MeSH terms:

Neoplasms

Fentanyl

Study Results

No Results Posted as of Jun 23, 2014