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

Not Applicable

Withdrawn

• Conditions: Laparoscopic Colorectal Resection Due to Cancer
• Interventions: Drug: IV ketamine/lidocaine/IV PCA apply; Drug: IV PCA only apply

• Registration Number: NCT03462836
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-02-06
• Study First Submitted QC: 2018-03-05
• Study First Posted: 2018-03-13
• Study Start: 2019-04
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-04
• Last Update Posted: 2019-07-08
• Primary Completion: 2019-12-31
• Study Completion: 2021-09-28

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. elective laparoscopic colorectal resection due to colorectal cancer
2. curative, resectable operation
3. ASA classification Ⅰ-Ⅲ

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IV ketamine/lidocaine/IV PCA (MA) group	IV ketamine/lidocaine/IV PCA apply	In addition to basic anesthetic methods, multimodal analgesia with IV ketamine, lidocaine and IV PCA apply
IV PCA only (CA) group	IV PCA only apply	In addition to basic anesthetic methods, only IC PCA apply for pain control

Primary Outcome Measures

Name	Time	Method
natural killer cell cytotoxicity	postoperative day #3	Natural killer cell cytotoxicity is measured with NK Vue Kit™(ATGen, Gyeonggi-do, Korea).

Trial Locations

Locations (1)

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