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Influence of Epidural Analgesia on Natural Killer Cell (NK) Activity After Colonic Cancer Surgery

Primary Purpose

Colonic Neoplasms

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Ropivacaine
Fentanyl
Propofol
Isoflurane
Nitrous Oxide
Sponsored by
Hillel Yaffe Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colonic Neoplasms focused on measuring Epidural Analgesia, Natural Killer Cells

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients undergoing colonic cancer surgery

Exclusion Criteria:

  • Patients with poor physical status Patients needed emergency surgery Coagulopathic disorders with international normalized ratio (INR) level more than 1.4 Thrombocytopenia with platelets count less 100000 per mcl Allergic reaction to local anesthetics in patient history Failure to performing the epidural analgesia from another cause Preoperative immunomodulating treatment Recent history of chemotherapy or radiation therapy

Sites / Locations

  • Hillel Yaffe Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

General Anesthesia

Combined anesthesia

Arm Description

Patients receiving general anesthesia with Fentanyl,Propofol, Isoflurane and Nitrous Oxide only during colonic cancer surgery

Patients receiving general anesthesia and epidural analgesia with Ropivacaine during colonic cancer surgery

Outcomes

Primary Outcome Measures

Count of live and dead target erythroleukemic cells
All clinical and laboratory parameters from blood samples taken before and after the operation will be compared between the two groups of patients. The nominal data comparison will be performed by ANOVA test, and the nonparametric data will be performed by Mann-Whitney test and interquartile ranges (IQR) for non-normally distributed data.
Plasma concentration of cytokines
All clinical and laboratory parameters from blood samples taken before and after the operation will be compared between the two groups of patients. The nominal data comparison will be performed by ANOVA test, and the nonparametric data will be performed by Mann-Whitney test and interquartile ranges (IQR) for non-normally distributed data.

Secondary Outcome Measures

Full Information

First Posted
December 10, 2014
Last Updated
December 22, 2014
Sponsor
Hillel Yaffe Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02326727
Brief Title
Influence of Epidural Analgesia on Natural Killer Cell (NK) Activity After Colonic Cancer Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Unknown status
Study Start Date
April 2015 (undefined)
Primary Completion Date
April 2017 (Anticipated)
Study Completion Date
May 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hillel Yaffe Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Regional anesthesia may decrease the release of endogenous opioids, increase Natural Killer cell (NK) function and decrease development of metastasis. The recent analysis of the Cancer Registry has noted an improved 5-year survival in patients who received epidural analgesia during surgery for colorectal carcinoma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Neoplasms
Keywords
Epidural Analgesia, Natural Killer Cells

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
General Anesthesia
Arm Type
Active Comparator
Arm Description
Patients receiving general anesthesia with Fentanyl,Propofol, Isoflurane and Nitrous Oxide only during colonic cancer surgery
Arm Title
Combined anesthesia
Arm Type
Active Comparator
Arm Description
Patients receiving general anesthesia and epidural analgesia with Ropivacaine during colonic cancer surgery
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Intervention Description
Epidural analgesia
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Intervention Description
General Anesthesia
Intervention Type
Drug
Intervention Name(s)
Propofol
Intervention Description
General Anesthesia
Intervention Type
Drug
Intervention Name(s)
Isoflurane
Intervention Description
General Anesthesia
Intervention Type
Drug
Intervention Name(s)
Nitrous Oxide
Intervention Description
General Anesthesia
Primary Outcome Measure Information:
Title
Count of live and dead target erythroleukemic cells
Description
All clinical and laboratory parameters from blood samples taken before and after the operation will be compared between the two groups of patients. The nominal data comparison will be performed by ANOVA test, and the nonparametric data will be performed by Mann-Whitney test and interquartile ranges (IQR) for non-normally distributed data.
Time Frame
72 hours
Title
Plasma concentration of cytokines
Description
All clinical and laboratory parameters from blood samples taken before and after the operation will be compared between the two groups of patients. The nominal data comparison will be performed by ANOVA test, and the nonparametric data will be performed by Mann-Whitney test and interquartile ranges (IQR) for non-normally distributed data.
Time Frame
72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients undergoing colonic cancer surgery Exclusion Criteria: Patients with poor physical status Patients needed emergency surgery Coagulopathic disorders with international normalized ratio (INR) level more than 1.4 Thrombocytopenia with platelets count less 100000 per mcl Allergic reaction to local anesthetics in patient history Failure to performing the epidural analgesia from another cause Preoperative immunomodulating treatment Recent history of chemotherapy or radiation therapy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Leonid Reytman, MD
Phone
972-4-6304257
Email
lrey@netvision.net.il
Facility Information:
Facility Name
Hillel Yaffe Medical Center
City
Hadera
ZIP/Postal Code
38100
Country
Israel

12. IPD Sharing Statement

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Influence of Epidural Analgesia on Natural Killer Cell (NK) Activity After Colonic Cancer Surgery

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