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

NCT ID: NCT02012244

Last Updated: 2016-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2015-12-31

Brief 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

Conditions

Colorectal Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

fentanyl-based analgesia

fentanyl intravenous patient-controlled analgesia + additional pethidine

Group Type: EXPERIMENTAL

fentanyl-based analgesia

Intervention Type: DRUG

fentanyl based patient-controlled analgesia + additional pethidine for postoperative 48 hour

local anesthetic wound infiltration-based anlagesia

continuous wound inflitration with ropivacaine + tramadol intravenous patient-controlled analgesia + additional ketorolac or propacetamol

Group Type: EXPERIMENTAL

local anesthetic wound infiltration-based anlagesia

Intervention Type: DRUG

continuous wound inflitration with ropivacaine + tramadol patient-controlled analgesia + additional ketorolac or propacetamol for postoperative 48 hour

Interventions

fentanyl-based analgesia

fentanyl based patient-controlled analgesia + additional pethidine for postoperative 48 hour

Intervention Type: DRUG

local anesthetic wound infiltration-based anlagesia

continuous wound inflitration with ropivacaine + tramadol patient-controlled analgesia + additional ketorolac or propacetamol for postoperative 48 hour

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Severance Hospital

OTHER

Sponsor Role: lead

Responsible Party

So Yeon Kim

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Sedoul, , South Korea

Countries

South Korea

Other Identifiers

4-2013-0044

Identifier Type: -

Identifier Source: org_study_id