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

Colonic Neoplasms Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02326727
• Other study ID #: 0095-14-HYMC
• Status: Not yet recruiting
• Phase: N/A
• First received: December 10, 2014
• Last updated: December 22, 2014
• Start date: April 2015
• Est. completion date: May 2017

Study information

• Verified date: December 2014
• Source: Hillel Yaffe Medical Center
• Contact: Leonid Reytman, MD
• Phone: 972-4-6304257
• Email: lrey[@]netvision.net.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: May 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colonic Neoplasms

Intervention

Drug:
• Ropivacaine
Epidural analgesia
• Fentanyl
General Anesthesia
• Propofol
General Anesthesia
• Isoflurane
General Anesthesia
• Nitrous Oxide
General Anesthesia

Locations

Country	Name	City	State
Israel	Hillel Yaffe Medical Center	Hadera

Sponsors (1)

Lead Sponsor	Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No