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

January 10, 2016 updated by: So Yeon Kim, Severance Hospital
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Sedoul, Korea, Republic of
        • Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: fentanyl-based analgesia
fentanyl intravenous patient-controlled analgesia + additional pethidine
Drug: fentanyl-based analgesia
fentanyl based patient-controlled analgesia + additional pethidine for postoperative 48 hour
Experimental: local anesthetic wound infiltration-based anlagesia
continuous wound inflitration with ropivacaine + tramadol intravenous patient-controlled analgesia + additional ketorolac or propacetamol
Drug: local anesthetic wound infiltration-based anlagesia
continuous wound inflitration with ropivacaine + tramadol patient-controlled analgesia + additional ketorolac or propacetamol for postoperative 48 hour

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NK cell activity
Time Frame: 48 hours
NK cell activity : preoperation, POD 1, POD 2
48 hours
IL-2
Time Frame: 48 hours
IL-2 level : preoperation, POD 1, POD 2
48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complication and recurrence
Time Frame: 1 year
Postoperative complication, recurrence
1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inflammatory responses
Time Frame: 48 hours
White blood cell, neutrophil, C-reactive protein (CRP) : preoperation, POD 1, POD 2
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Severance Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

December 7, 2013

First Submitted That Met QC Criteria

December 10, 2013

First Posted (Estimate)

December 16, 2013

Study Record Updates

Last Update Posted (Estimate)

January 12, 2016

Last Update Submitted That Met QC Criteria

January 10, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2013-0044

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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