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

Not Applicable

• Conditions: Colonic Neoplasms
• Interventions: Drug: Fentanyl; Drug: Ropivacaine; Drug: Propofol; Drug: Isoflurane; Drug: Nitrous Oxide

• Registration Number: NCT02326727
• Lead Sponsor: Hillel Yaffe Medical Center

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-12
• Study First Submitted: 2014-12-10
• Study First Submitted QC: 2014-12-22
• Last Update Submitted: 2014-12-22
• Study First Posted: 2014-12-29
• Last Update Posted: 2014-12-29
• Study Start: 2015-04
• Primary Completion: 2017-04
• Study Completion: 2017-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
General Anesthesia	Propofol	Patients receiving general anesthesia with Fentanyl,Propofol, Isoflurane and Nitrous Oxide only during colonic cancer surgery
General Anesthesia	Isoflurane	Patients receiving general anesthesia with Fentanyl,Propofol, Isoflurane and Nitrous Oxide only during colonic cancer surgery
General Anesthesia	Fentanyl	Patients receiving general anesthesia with Fentanyl,Propofol, Isoflurane and Nitrous Oxide only during colonic cancer surgery
Combined anesthesia	Ropivacaine	Patients receiving general anesthesia and epidural analgesia with Ropivacaine during colonic cancer surgery
Combined anesthesia	Isoflurane	Patients receiving general anesthesia and epidural analgesia with Ropivacaine during colonic cancer surgery
Combined anesthesia	Fentanyl	Patients receiving general anesthesia and epidural analgesia with Ropivacaine during colonic cancer surgery
Combined anesthesia	Propofol	Patients receiving general anesthesia and epidural analgesia with Ropivacaine during colonic cancer surgery
General Anesthesia	Nitrous Oxide	Patients receiving general anesthesia with Fentanyl,Propofol, Isoflurane and Nitrous Oxide only during colonic cancer surgery
Combined anesthesia	Nitrous Oxide	Patients receiving general anesthesia and epidural analgesia with Ropivacaine during colonic cancer surgery

Primary Outcome Measures

Name	Time	Method
Count of live and dead target erythroleukemic cells	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.
Plasma concentration of cytokines	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.

Trial Locations

Locations (1)

Hillel Yaffe Medical Center; 🇮🇱 Hadera, Israel