Opioid-based Analgesic Regimen Versus Non-opioid Analgesic Regimen for Better Immune Responses After Laparoscopic Colorectal Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Severance Hospital
Sponsor:
Information provided by (Responsible Party):
So Yeon Kim, Severance Hospital
ClinicalTrials.gov Identifier:
NCT02012244
First received: December 7, 2013
Last updated: January 2, 2014
Last verified: January 2014
  Purpose

The purpose of this study is to compare immune responses (e.g. NK cell activity) of opioid-based analgesic regimen versus non-opioid anlagesic regimen after laparoscopic colorectal surgery


Condition Intervention
Colorectal Surgery
Drug: opioid based analgesia (fentanyl and pethidine) versus non-opioid based analgesia (ropivacaine and tramadol)

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: No ]
    NK cell activity : preoperation, just after operation, POD 1, POD 2


Secondary Outcome Measures:
  • Cytokine level [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    Cytokine level : preoperation, just after operation, POD 1, POD 2


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


Estimated Enrollment: 100
Study Start Date: January 2014
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Opioid based analgesia
fentanyl based patient-controlled analgesia + additional opioid analgesics (pethidine)
Drug: opioid based analgesia (fentanyl and pethidine) versus non-opioid based analgesia (ropivacaine and tramadol)
Opioid based analgesia : fentanyl based patient-controlled analgesia + additional opioid analgesics (pethidine) for postoperative 48 hour Non-opioid based analgesia : continuous wound inflitration with ropivacaine + tramadol patient-controlled analgesia for postoperative 48 hour
Experimental: Non-opioid based analgesia
continuous wound inflitration with ropivacaine + tramadol patient-controlled analgesia
Drug: opioid based analgesia (fentanyl and pethidine) versus non-opioid based analgesia (ropivacaine and tramadol)
Opioid based analgesia : fentanyl based patient-controlled analgesia + additional opioid analgesics (pethidine) for postoperative 48 hour Non-opioid based analgesia : continuous wound inflitration with ropivacaine + tramadol patient-controlled analgesia for postoperative 48 hour

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA class I-III
  • 20-80 years old
  • elective laparoscopic colorectal surgery

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

Contacts
Contact: So Yeon Kim, MD, PhD 82-2227-4470 KIMSY326@yuhs.ac

Locations
Korea, Republic of
Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine Recruiting
Sedoul, Korea, Republic of
Contact: So Yeon Kim, MD, PhD    82-2227-4470      
Sponsors and Collaborators
Severance Hospital
  More Information

No publications provided

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 2, 2014
Health Authority: Korea: Institutional Review Board

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

Additional relevant MeSH terms:
Analgesics
Analgesics, Non-Narcotic
Analgesics, Opioid
Fentanyl
Tramadol
Ropivacaine
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Anesthetics, Local

ClinicalTrials.gov processed this record on September 22, 2014