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

Ketamine

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.

Intervention / Treatment

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

Condition or Disease

  • Laparoscopic Colorectal Resection Due to Cancer

Phase

  • Not Applicable

    • Study Design

    Study type: INTERVENTIONAL
    Status: Withdrawn
    Study results: No Results Available
    Age: 20 Years to 70 Years
    Enrollment: 0 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    TRIPLE:
    • Participant
    • Care Provider
    • Investigator

    Clinical Trial Dates

    Start date: Apr 01, 2019 ESTIMATED
    Primary Completion: Dec 31, 2019 ESTIMATED
    Completion Date: Sep 28, 2021 ESTIMATED
    Study First Posted: Mar 13, 2018 ACTUAL
    Results First Posted: Aug 31, 2020
    Last Updated: Jul 04, 2019

    Sponsors / Collaborators

    Lead Sponsor: Yonsei University
    Lead sponsor is responsible party
    Responsible Party: N/A

    Location

    South Korea
    Seoul, South Korea

    Participant Groups

    • 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

    Eligibility Criteria

    Sex: All
    Minimum Age: 20
    Maximum Age: 70
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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

    Primary Outcomes

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

    More Details

    NCT Number: NCT03462836
    Other IDs: 4-2017-0773
    Study URL: https://clinicaltrials.gov/study/NCT03462836
    Last updated: Sep 29, 2023