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Completed

NCT Number: NCT02012244

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

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

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Key information

Conditions

Colorectal Surgery Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Sedoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

fentanyl-based analgesia

Drug

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

local anesthetic wound infiltration-based anlagesia

Drug

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

Primary outcomes

  1. NK cell activity

    Time frame: 48 hours

    NK cell activity : preoperation, POD 1, POD 2

  2. IL-2

    Time frame: 48 hours

    IL-2 level : preoperation, POD 1, POD 2

Secondary outcomes

  1. Complication and recurrence

    Time frame: 1 year

    Postoperative complication, recurrence

Other outcomes

  1. Inflammatory responses

    Time frame: 48 hours

    White blood cell, neutrophil, C-reactive protein (CRP) : preoperation, POD 1, POD 2

Sponsors and collaborators

Lead sponsor

Severance Hospital

Other

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Dec 16, 2013
Registry last updated
Jan 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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