Effects of Postoperative Pain Management on Immune Function After Laparoscopic Resection of Colorectal Cancer

Colorectal Surgery Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02012244
• Other study ID #: 4-2013-0044
• Status: Completed
• Phase: N/A
• First received: December 7, 2013
• Last updated: January 10, 2016
• Start date: January 2014
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: Severance Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare postoperative immune function (e.g. NK cell activity) of fentanyl-based analgesic regimen versus local anesthetic wound infiltration-based anlagesic regimen after laparoscopic colorectal surgery

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• ASA class I-III

• 20-80 years old

• elective laparoscopic colorectal surgery for cancer

Exclusion Criteria:

• drug allergy

• significant renal or hepatic impairment

• sign of infection

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Colorectal Surgery

Intervention

Drug:
• fentanyl-based analgesia
fentanyl based patient-controlled analgesia + additional pethidine for postoperative 48 hour
• local anesthetic wound infiltration-based anlagesia
continuous wound inflitration with ropivacaine + tramadol patient-controlled analgesia + additional ketorolac or propacetamol for postoperative 48 hour

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine	Sedoul

Sponsors (1)

Lead Sponsor	Collaborator
Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Inflammatory responses	White blood cell, neutrophil, C-reactive protein (CRP) : preoperation, POD 1, POD 2	48 hours	Yes
Primary	NK cell activity	NK cell activity : preoperation, POD 1, POD 2	48 hours	Yes
Primary	IL-2	IL-2 level : preoperation, POD 1, POD 2	48 hours	Yes
Secondary	Complication and recurrence	Postoperative complication, recurrence	1 year	Yes