Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

n/a


Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science


Related Conditions & MeSH terms


NCT number NCT01646775
Study type Interventional
Source McGill University Health Center
Contact Albert Moore
Phone 514-934-1934
Email moore_albert@hotmail.com
Status Recruiting
Phase N/A
Start date July 2012
Completion date December 2014

See also
  Status Clinical Trial Phase
Recruiting NCT05640115 - Obstruction of Malignancy: Percutaneous Renal vs Endoscopic Stent Early Phase 1
Recruiting NCT02891642 - Liquid Biopsy With Immunomagnetic Beads Capture Technique for Malignant Cell Detection in Body Fluid
Completed NCT02282449 - Power Injectable Versus a Non-Power Injectable, Upper Arm, TIVAD for Chemotherapy N/A
Completed NCT01212731 - Skull Base and Low Grade Glioma Neurocognitive Magnetic Resonance Imaging (MRI) Study
Completed NCT01199822 - Study of the Safety and Pharmacokinetics of IMC-3G3 in Japanese Patients With Solid Tumors Phase 1
Recruiting NCT04122469 - The Role of Stereo-tActic BoDy RadIotherApy iN Oligo-Progressive MalignanT Disease N/A
Recruiting NCT03561727 - Risk Factors for Development of Incisional Hernia in Transverse Incisions N/A
Terminated NCT03251924 - A Dose Escalation and Combination Immunotherapy Study to Evaluate BMS-986226 Alone or in Combination With Nivolumab or Ipilimumab in Patients With Advanced Solid Tumors Phase 1/Phase 2
Active, not recruiting NCT03997968 - A Phase 1/2 Study of CYT-0851 in B-Cell Malignancies and Advanced Solid Tumors Phase 1/Phase 2
Active, not recruiting NCT00092222 - Virotherapy and Natural History Study of KHSV-Associated Multricentric Castleman s Disease With Correlates of Disease Activity Phase 2
Recruiting NCT05770102 - DETERMINE Trial Treatment Arm 02: Atezolizumab in Adult, Teenage/Young Adults and Paediatric Patients With Cancers With High Tumour Mutational Burden (TMB) or Microsatellite Instability-high (MSI-high) or Proven Constitutional Mismatch Repair Deficiency (CMMRD) Disposition Phase 2/Phase 3
Recruiting NCT05886764 - Novel Outreach Methods to Increase Enrollment to Early Phase Clinical Trials N/A
Not yet recruiting NCT05992363 - Tandem Polyurethane Stents Compared to Single Silicone Stent for Malignant Ureteral Obstruction Phase 3
Recruiting NCT05761366 - Application of 18F-PSMA PET / CT Imaging in Prostate Specific Membrane Antigen Positive Tumor Phase 2
Recruiting NCT04887545 - Immune- and Microenvironment- Proteogenomics Profiling for Classifying Lung Cancer Patients
Completed NCT03061955 - Safety and Efficacy of Concurrent Administration of Influenza Vaccine in Patients Undergoing Anti-PD-1 Immunotherapy (Nivolumab, Pembrolizumab)
Completed NCT03909464 - Non-Invasive Neurosensory Testing For Chemotherapy-Induced Peripheral Neuropathy
Active, not recruiting NCT02649491 - Using an Electronic Nose to Predict Gastrointestinal Consequences of Pelvic Radiotherapy N/A
Recruiting NCT02776995 - Tumor Monitoring Using Thermography During Radiation Therapy N/A
Active, not recruiting NCT01242072 - Intravenous Palifosfamide-tris in Combination With Etoposide and Carboplatin in Patients With Malignancies Phase 1