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Clinical Trials/NCT03462836
NCT03462836
Withdrawn
Not Applicable

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

Yonsei University1 site in 1 countryApril 2019

Overview

Phase
Not Applicable
Intervention
IV ketamine/lidocaine/IV PCA apply
Conditions
Laparoscopic Colorectal Resection Due to Cancer
Sponsor
Yonsei University
Locations
1
Primary Endpoint
natural killer cell cytotoxicity
Status
Withdrawn
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2019
End Date
September 28, 2021
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Arms & Interventions

IV ketamine/lidocaine/IV PCA (MA) group

In addition to basic anesthetic methods, multimodal analgesia with IV ketamine, lidocaine and IV PCA apply

Intervention: IV ketamine/lidocaine/IV PCA apply

IV PCA only (CA) group

In addition to basic anesthetic methods, only IC PCA apply for pain control

Intervention: IV PCA only apply

Outcomes

Primary Outcomes

natural killer cell cytotoxicity

Time Frame: postoperative day #3

Natural killer cell cytotoxicity is measured with NK Vue Kit™(ATGen, Gyeonggi-do, Korea).

Study Sites (1)

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