Clinical Trials Logo
  1. Home
  2. Other
  3. NCT03462836
  4. Details
NCT03462836 Clinical 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

Laparoscopic Colorectal Resection Due to Cancer Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT03462836
Other study ID # 4-2017-0773
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date April 2019
Est. completion date September 28, 2021

Study information
Verified date July 2019
Source Yonsei University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date September 28, 2021
Est. primary completion date December 31, 2019
Accepts healthy volunteers No
Gender All
Age group 20 Years to 70 Years
Eligibility Inclusion Criteria:

1. elective laparoscopic colorectal resection due to colorectal cancer

2. curative, resectable operation

3. ASA classification ?-?

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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Korea, Republic of Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea Seoul

Sponsors (1)
Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

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