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

Study Overview
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Brief Summary
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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.

Conditions
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Colonic Neoplasms

Intervention / Treatment
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* Drug: Ropivacaine
* Drug: Fentanyl
* Drug: Propofol
* Drug: Isoflurane
* Drug: Nitrous Oxide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: General Anesthesia<br>Patients receiving general anesthesia with Fentanyl,Propofol, Isoflurane and Nitrous Oxide only during colonic cancer surgery | Drug: Fentanyl<br>* General Anesthesia<br>Drug: Propofol<br>* General Anesthesia<br>Drug: Isoflurane<br>* General Anesthesia<br>Drug: Nitrous Oxide<br>* General Anesthesia<br>|
| Active Comparator: Combined anesthesia<br>Patients receiving general anesthesia and epidural analgesia with Ropivacaine during colonic cancer surgery | Drug: Ropivacaine<br>* Epidural analgesia<br>Drug: Fentanyl<br>* General Anesthesia<br>Drug: Propofol<br>* General Anesthesia<br>Drug: Isoflurane<br>* General Anesthesia<br>Drug: Nitrous Oxide<br>* General Anesthesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 72 hours | 
| 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. | 72 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epidural Analgesia, Natural Killer Cells