Back to results

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

Primary Purpose

Laparoscopic Colorectal Resection Due to Cancer

Status

Withdrawn

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

IV ketamine/lidocaine/IV PCA apply

IV PCA only apply

About this trial

This is an interventional treatment trial for Laparoscopic Colorectal Resection Due to Cancer

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

IV ketamine/lidocaine/IV PCA (MA) group

IV PCA only (CA) group

Arm Description

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

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

Outcomes

Primary Outcome Measures

natural killer cell cytotoxicity

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03462836

First Posted

February 6, 2018

Last Updated

July 4, 2019

Sponsor

Yonsei University

1. Study Identification

Unique Protocol Identification Number

NCT03462836

Brief 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

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Withdrawn

Why Stopped

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.

Study Start Date

April 2019 (Anticipated)

Primary Completion Date

December 31, 2019 (Anticipated)

Study Completion Date

September 28, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yonsei University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Laparoscopic Colorectal Resection Due to Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

IV ketamine/lidocaine/IV PCA (MA) group

Arm Type

Experimental

Arm Description

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

Arm Title

IV PCA only (CA) group

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

IV ketamine/lidocaine/IV PCA apply

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

IV PCA only apply

Intervention Description

IV PCA (fentanyl 10mcg/kg + nefopam (Acupan®) 80mg + Ramosetron (Nasea®) ) apply 30min before end of surgery.

Primary Outcome Measure Information:

Title

natural killer cell cytotoxicity

Description

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

Time Frame

postoperative day #3

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

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

City

Seoul

ZIP/Postal Code

03722

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs