Epidural-inhalational Versus Epidural-intravenous Anaesthesia on Anti-tumor Immunity in Patients With Cancer Colon

Study Overview
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Brief Summary
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Surgery is the primary treatment for colon cancer. However, the rate of recurrence or metastasis in colon cancer can be as high as 30%, even in stages 1 and 2 . Most colon cancer-related deaths are caused by metastatic disease . Many patients with colon cancer harbour micrometastases and disseminated tumour cells at the time of surgery . Whether the micrometastases develop into clinically significant metastases depends on the immune system's ability to eradicate them.The aim of the study is to declare the effect of epidural-intravenous based anesthetic technique on anti-tumor immunity and in comparison to epidural inhalational based anesthetic technique in patients undergoing open surgical resection of colon cancer.

Official Title
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Effect of Epidural-inhalational Versus Epidural-intravenous Anaesthesia on Anti-tumor Immunity in Patients Undergoing Open Surgery for Cancer Colon

Conditions
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Immunity Factors in Cancer Colon Patients

Intervention / Treatment
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* Procedure: thoracic epidural


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 20-70 yrs. ASA class I and II Elective open surgery for non-metastatic cancer colon stage I,II Exclusion Criteria: Patient refusal Known allergy to the study medications Patients with compromised immune function ( associated blood diseases, immunosuppressive drugs, chemotherapeutic agents, corticosteroids) Contraindications to epidural insertion e.g. infection at insertion site and coagulopathy

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Group (EP) received epidural - propofol based anesthetic technique and postoperative analgesia through patient controlled epidural analgesia and Group (EH) received epidural- inhalational based anesthetic technique and postoperative analgesia through patient controlled epidural analgesia
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group (EP)<br>Group (EP) received epidural (fentanyl and bupivacaine) - propofol based anesthetic technique and postoperative analgesia through patient controlled analgesia device (PCA) | Procedure: thoracic epidural<br>* undergo insertion of an epidural catheter, between T9 and T11 in patients undergoing left-sided resections and between T8 and T10 in patients undergoing right-sided resections<br>* Other names: thoracic epidural catheter;|
| Active Comparator: Group (EH)<br>Group (EH) received epidural (fentanyl and bupivacaine)- inhalational based anesthetic technique and postoperative analgesia through patient controlled analgesia device (PCA) | Procedure: thoracic epidural<br>* undergo insertion of an epidural catheter, between T9 and T11 in patients undergoing left-sided resections and between T8 and T10 in patients undergoing right-sided resections<br>* Other names: thoracic epidural catheter;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anti tumour immunity | Venous blood samples are withdrawn. Samples for measurement of percentage of expression of CD8,CD16 and CD56 will be collected in sodium heparin anticoagulant tubes and will be processed according to manufacturer's instructions,and samples for VEGF-C will be centrifuged at 4000 g. Thereafter, the serum will be stored at -22 C for future measurement | preoperative and Day 1 postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in pain intensity | pain intensity measured by Visual analogue scale from 0 to 10 where 0 no pain and 10 is sever pain | 24 hours postoperative |