- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02326727
Influence of Epidural Analgesia on Natural Killer Cell (NK) Activity After Colonic Cancer Surgery
December 22, 2014 updated by: Hillel Yaffe Medical Center
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Hadera, Israel, 38100
- Hillel Yaffe Medical Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: General Anesthesia
Patients receiving general anesthesia with Fentanyl,Propofol, Isoflurane and Nitrous Oxide only during colonic cancer surgery
|
General Anesthesia
General Anesthesia
General Anesthesia
General Anesthesia
|
Active Comparator: Combined anesthesia
Patients receiving general anesthesia and epidural analgesia with Ropivacaine during colonic cancer surgery
|
General Anesthesia
General Anesthesia
General Anesthesia
General Anesthesia
Epidural analgesia
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Count of live and dead target erythroleukemic cells
Time Frame: 72 hours
|
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.
|
72 hours
|
Plasma concentration of cytokines
Time Frame: 72 hours
|
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.
|
72 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2015
Primary Completion (Anticipated)
April 1, 2017
Study Completion (Anticipated)
May 1, 2017
Study Registration Dates
First Submitted
December 10, 2014
First Submitted That Met QC Criteria
December 22, 2014
First Posted (Estimate)
December 29, 2014
Study Record Updates
Last Update Posted (Estimate)
December 29, 2014
Last Update Submitted That Met QC Criteria
December 22, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Colorectal Neoplasms
- Colonic Neoplasms
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Analgesics, Non-Narcotic
- Analgesics, Opioid
- Narcotics
- Hypnotics and Sedatives
- Adjuvants, Anesthesia
- Anesthetics, Local
- Anesthetics, Inhalation
- Fentanyl
- Propofol
- Nitrous Oxide
- Ropivacaine
- Isoflurane
Other Study ID Numbers
- 0095-14-HYMC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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