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

NCT ID: NCT03462836

Last Updated: 2019-07-08

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-30
• Study Completion Date: 2021-09-28

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.

Conditions

Laparoscopic Colorectal Resection Due to Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

IV ketamine/lidocaine/IV PCA (MA) group

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

Group Type: EXPERIMENTAL

IV ketamine/lidocaine/IV PCA apply

Intervention Type: DRUG

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 (CA) group

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

Group Type: ACTIVE_COMPARATOR

IV PCA only apply

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

IV PCA only apply

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. elective laparoscopic colorectal resection due to colorectal cancer

2. curative, resectable operation

3. ASA classification Ⅰ-Ⅲ

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Seoul, , South Korea

Countries

South Korea

Other Identifiers

4-2017-0773

Identifier Type: -

Identifier Source: org_study_id