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

Sponsor

Hillel Yaffe Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT02326727

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Colonic Neoplasms	Drug: Ropivacaine Drug: Fentanyl Drug: Propofol Drug: Isoflurane Drug: Nitrous Oxide	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

Study Start Date :

Apr 1, 2015

Anticipated Primary Completion Date :

Apr 1, 2017

Anticipated Study Completion Date :

May 1, 2017

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: General Anesthesia

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

Drug: Fentanyl

General Anesthesia

Drug: Propofol

General Anesthesia

Drug: Isoflurane

General Anesthesia

Drug: Nitrous Oxide

General Anesthesia

Active Comparator: Combined anesthesia

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

Drug: Ropivacaine

Epidural analgesia

Drug: Fentanyl

General Anesthesia

Drug: Propofol

General Anesthesia

Drug: Isoflurane

General Anesthesia

Drug: Nitrous Oxide

General Anesthesia

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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