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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Recruitment Status : Withdrawn (The results of the primary endpoints of this study are expected to be difficult to identify, thus canceling the study to readjust the study plan.)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

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.


Condition or disease Intervention/treatment Phase
Laparoscopic Colorectal Resection Due to Cancer Drug: IV ketamine/lidocaine/IV PCA apply Drug: IV PCA only apply Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Effects of Optimizing Post-operative Pain Management With Multi Modal Analgesia on Immune Suppression and Oncologic Outcome in Patients Undergoing Laparoscopic Colorectal Surgery
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : September 28, 2021

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Arm Intervention/treatment
Experimental: IV ketamine/lidocaine/IV PCA (MA) group
In addition to basic anesthetic methods, multimodal analgesia with IV ketamine, lidocaine and IV PCA apply
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.

Active Comparator: IV PCA only (CA) group
In addition to basic anesthetic methods, only IC PCA apply for pain control
Drug: IV PCA only apply
IV PCA (fentanyl 10mcg/kg + nefopam (Acupan®) 80mg + Ramosetron (Nasea®) ) apply 30min before end of surgery.




Primary Outcome Measures :
  1. natural killer cell cytotoxicity [ Time Frame: postoperative day #3 ]
    Natural killer cell cytotoxicity is measured with NK Vue Kit™(ATGen, Gyeonggi-do, Korea).



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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03462836


Locations
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Korea, Republic of
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea
Seoul, Korea, Republic of, 03722
Sponsors and Collaborators
Yonsei University

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT03462836     History of Changes
Other Study ID Numbers: 4-2017-0773
First Posted: March 13, 2018    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Lidocaine
Ketamine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Analgesics
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents