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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Laparoscopic Colorectal Resection Due to Cancer

Intervention / Treatment
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* Drug: IV ketamine/lidocaine/IV PCA apply
* Drug: IV PCA only apply


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: elective laparoscopic colorectal resection due to colorectal cancer curative, resectable operation ASA classification Ⅰ-Ⅲ Exclusion Criteria: elective co-operation due to distance metastasis preoperative chemo/radiation therapy drug allergy to opioid, tramadol, local anesthetics MAOi medication (within 14 days of surgery) decreased hepatic/renal function Patients who can not read the consent form or are not fluent in Korean (illiterate, foreigner pregnant, lactating women palliative surgery

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IV ketamine/lidocaine/IV PCA (MA) group<br>In addition to basic anesthetic methods, multimodal analgesia with IV ketamine, lidocaine and IV PCA apply | Drug: IV ketamine/lidocaine/IV PCA apply<br>* 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.<br>|
| Active Comparator: IV PCA only (CA) group<br>In addition to basic anesthetic methods, only IC PCA apply for pain control | Drug: IV PCA only apply<br>* IV PCA (fentanyl 10mcg/kg + nefopam (Acupan®) 80mg + Ramosetron (Nasea®) ) apply 30min before end of surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| natural killer cell cytotoxicity | Natural killer cell cytotoxicity is measured with NK Vue Kit™(ATGen, Gyeonggi-do, Korea). | postoperative day #3 |