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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
So Yeon Kim, Severance Hospital
ClinicalTrials.gov Identifier:
NCT02012244
First received: December 7, 2013
Last updated: January 10, 2016
Last verified: January 2016
  Purpose
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

Condition Intervention
Colorectal Surgery
Drug: fentanyl-based analgesia
Drug: local anesthetic wound infiltration-based anlagesia

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

Resource links provided by NLM:


Further study details as provided by Severance Hospital:

Primary Outcome Measures:
  • NK cell activity [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]
    NK cell activity : preoperation, POD 1, POD 2

  • IL-2 [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]
    IL-2 level : preoperation, POD 1, POD 2


Secondary Outcome Measures:
  • Complication and recurrence [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Postoperative complication, recurrence


Other Outcome Measures:
  • Inflammatory responses [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]
    White blood cell, neutrophil, C-reactive protein (CRP) : preoperation, POD 1, POD 2


Enrollment: 60
Study Start Date: January 2014
Study Completion Date: December 2015
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02012244

Locations
Korea, Republic of
Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Sedoul, Korea, Republic of
Sponsors and Collaborators
Severance Hospital
  More Information

Responsible Party: So Yeon Kim, Assistant professor, Severance Hospital
ClinicalTrials.gov Identifier: NCT02012244     History of Changes
Other Study ID Numbers: 4-2013-0044 
Study First Received: December 7, 2013
Last Updated: January 10, 2016
Health Authority: Korea: Institutional Review Board

Keywords provided by Severance Hospital:
analgesia; colorectal surgery; immunity; local anesthetics; opioids

Additional relevant MeSH terms:
Anesthetics
Fentanyl
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General

ClinicalTrials.gov processed this record on August 29, 2016