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The Influence of Type of Anesthesia on Postoperative Pain

Sponsor
Seoul National University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04239794
Collaborator
(none)
468
Enrollment
3
Locations
2
Arms
23.4
Anticipated Duration (Months)
156
Patients Per Site
6.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The investigators designed a multi-center prospective randomized controlled trial to study the influence of the type of anesthesia on postoperative pain after laparoscopic colorectal cancer surgery. Half of the participants will be anesthetized with propofol and remifentanil, while the other half will be anesthetized with sevoflurane and remifentanil during the surgery. The investigators will measure opioid consumption and pain score in the acute postoperative phase.

Condition or Disease Intervention/Treatment Phase
N/A

Detailed Description

Previous studies showed that patients receiving total intravenous anesthesia (TIVA) with propofol are associated with less postoperative pain and less opioid consumption compared with inhalation anesthesia. However, some studies showed conflicting results. In colorectal surgery, there are only retrospective studies that showed the analgesic effect of TIVA and inhalation anesthesia. The investigators designed a multi-center prospective randomized controlled trial and hypothesized that TIVA with propofol would be associated with reduced postoperative opioid consumption and less postoperative pain compared with sevoflurane in laparoscopic colorectal cancer surgery.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
468 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
The Influence of Type of Anesthesia on Postoperative Pain After Laparoscopic Colorectal Cancer Surgery: Multi-center Prospective Randomized Controlled Study
Actual Study Start Date :
Feb 20, 2020
Anticipated Primary Completion Date :
Feb 1, 2022
Anticipated Study Completion Date :
Feb 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Inhalation anesthesia

Patients are anesthetized with sevoflurane and remifentanil infusion for maintenance of anesthesia during the surgery

Drug: Sevoflurane
General anesthesia during the laparoscopic colorectal surgery is achieved by using an inhalation agent (Sevoflurane).
Other Names:
  • Sevoflurane inhalant product

    		•
    Experimental: Total intravenous anesthesia

    Patients are anesthetized with target-controlled intravenous infusion of propofol and remifentanil infusion for maintenance of anesthesia during the surgery

    Drug: Propofol
    General anesthesia during the laparoscopic colorectal surgery is achieved by using a target-controlled intravenous infusion of propofol.
    Other Names:
  • Propofol 2%

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Postoperative 24 h opioid consumption [24 hours after the surgery]

      Cumulative opioid consumption for pain control 24 hours after the surgery

    Secondary Outcome Measures

    1. Postoperative 48 h opioid consumption [48 hours after the surgery]

      Cumulative opioid consumption for pain control 48 hours after the surgery

    2. Numerical rating scale (NRS) [24 and 48 hours after the surgery]

      Numerical rating scale (NRS) pain score 24 and 48 hours after the surgery. NRS is an 11-point scale for patient self-reporting of pain; 0-10 where 0 is no pain and 10 is the worst pain imaginable.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Adult patient scheduled for elective laparoscopic colorectal cancer surgery
    Exclusion Criteria:

    • Pregnant

    • Conversion from laparoscopic to open surgery

    • Allergy to anesthetics and analgesics

    • Previous abdominal surgery

    • Chronic pain

    • Chronic analgesic usage

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seoul National University Hospital Seoul Korea, Republic of 03080
    2 Seoul Metropolitan Government Seoul National University Boramae Medical Center Seoul Korea, Republic of 07061
    3 Seoul National University Bundang Hospital Seoul Korea, Republic of 13620

    Sponsors and Collaborators

    • Seoul National University Hospital

    Investigators

    • Principal Investigator: Jin-Tae Kim, PhD, Seoul National University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Jin-Tae Kim, Professor (full), Seoul National University Hospital
    ClinicalTrials.gov Identifier:
    NCT04239794
    Other Study ID Numbers:
    • TIVA-IA-Pain
    First Posted:
    Jan 27, 2020
    Last Update Posted:
    Mar 16, 2021
    Last Verified:
    Mar 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Jin-Tae Kim, Professor (full), Seoul National University Hospital
    Postoperative pain
    Opioid consumption
    Intraoperative anesthesia
    Additional relevant MeSH terms:
    Pain, Postoperative
    Propofol
    Sevoflurane

    Study Results

    No Results Posted as of Mar 16, 2021