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The Effects of Optimizing Post-operative Pain Management With Multi Modal Analgesia on Immune Suppression and Oncologic Outcome in Patients Undergoing Laparoscopic Colorectal Surgery

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ClinicalTrials.gov Identifier: NCT03462836
Recruitment Status : Withdrawn (The results of the primary endpoints of this study are expected to be difficult to identify, thus canceling the study to readjust the study plan.)
First Posted : March 13, 2018
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Tracking Information
First Submitted Date  ICMJE February 6, 2018
First Posted Date  ICMJE March 13, 2018
Last Update Posted Date July 8, 2019
Estimated Study Start Date  ICMJE April 2019
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 5, 2018)
natural killer cell cytotoxicity [ Time Frame: postoperative day #3 ]
Natural killer cell cytotoxicity is measured with NK Vue Kit™(ATGen, Gyeonggi-do, Korea).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effects of Optimizing Post-operative Pain Management With Multi Modal Analgesia on Immune Suppression and Oncologic Outcome in Patients Undergoing Laparoscopic Colorectal Surgery
Official Title  ICMJE The Effects of Optimizing Post-operative Pain Management With Multi Modal Analgesia on Immune Suppression and Oncologic Outcome in Patients Undergoing Laparoscopic Colorectal Surgery
Brief Summary

Traditionally, pain control methods based on narcotic analgesics have been used to control severe pain after surgery, but this has resulted in side effects such as vomiting, constipation, dizziness, mental confusion due to drugs, and respiratory depression. This slowed the recovery of the patient after surgery and increased the duration of hospitalization, which had a negative impact on the patient 's prognosis. In addition, research has been conducted on the use of various painkillers in a variety of ways over the past decade to reduce the dose of narcotic analgesics and to increase the effectiveness of pain control, since studies of anesthetics and narcotic analgesics have shown immunosuppressive effects.

This study investigate the effect of multimodal analgesics for postoperative pain control on immune function amd prognosis in patients undergoing laparoscopic colorectal cancer resection.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Laparoscopic Colorectal Resection Due to Cancer
Intervention  ICMJE
  • Drug: IV ketamine/lidocaine/IV PCA apply
    In the MA group, 1.0 mg / kg of ketamine is diluted to a total volume of 10 ml. Slowly apply for 1 minute during surgical drape. 1 mg / kg of Lidocaine is loaded at the beginning of surgery. Lidocaine 1.5 mg / kg / hr is administered until the end of the operation.
  • Drug: IV PCA only apply
    IV PCA (fentanyl 10mcg/kg + nefopam (Acupan®) 80mg + Ramosetron (Nasea®) ) apply 30min before end of surgery.
Study Arms  ICMJE
  • Experimental: IV ketamine/lidocaine/IV PCA (MA) group
    In addition to basic anesthetic methods, multimodal analgesia with IV ketamine, lidocaine and IV PCA apply
    Intervention: Drug: IV ketamine/lidocaine/IV PCA apply
  • Active Comparator: IV PCA only (CA) group
    In addition to basic anesthetic methods, only IC PCA apply for pain control
    Intervention: Drug: IV PCA only apply
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: July 4, 2019)
0
Original Estimated Enrollment  ICMJE
 (submitted: March 5, 2018)
100
Estimated Study Completion Date  ICMJE September 28, 2021
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. elective laparoscopic colorectal resection due to colorectal cancer
  2. curative, resectable operation
  3. ASA classification Ⅰ-Ⅲ

Exclusion Criteria:

  1. elective co-operation due to distance metastasis
  2. preoperative chemo/radiation therapy
  3. drug allergy to opioid, tramadol, local anesthetics
  4. MAOi medication (within 14 days of surgery)
  5. decreased hepatic/renal function
  6. Patients who can not read the consent form or are not fluent in Korean (illiterate, foreigner
  7. pregnant, lactating women
  8. palliative surgery
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03462836
Other Study ID Numbers  ICMJE 4-2017-0773
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Yonsei University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Yonsei University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Yonsei University
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP