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Recruitment Status : Withdrawn (The results of the primary endpoints of this study are expected to be difficult to identify, thus canceling the study to readjust the study plan.)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
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
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.
- natural killer cell cytotoxicity [ Time Frame: postoperative day #3 ]Natural killer cell cytotoxicity is measured with NK Vue Kit™(ATGen, Gyeonggi-do, Korea).
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
|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|