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Clinical Trial Details — Status: Withdrawn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
• Status: Withdrawn
• Phase: N/A
• 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
• 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• Status: Withdrawn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

Related Conditions & MeSH terms

• Laparoscopic Colorectal Resection Due to Cancer
• Pain, Postoperative

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