search
Back to results

The Influence of Type of Anesthesia on Postoperative Pain

Primary Purpose

Colo-rectal Cancer, Anesthesia

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Propofol
Sevoflurane
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colo-rectal Cancer focused on measuring Postoperative pain, Opioid consumption, Intraoperative anesthesia

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University HospitalRecruiting
  • Seoul Metropolitan Government Seoul National University Boramae Medical Center
  • Seoul National University Bundang Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Inhalation anesthesia

Total intravenous anesthesia

Arm Description

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

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

Outcomes

Primary Outcome Measures

Postoperative 24 h opioid consumption
Cumulative opioid consumption for pain control 24 hours after the surgery

Secondary Outcome Measures

Postoperative 48 h opioid consumption
Cumulative opioid consumption for pain control 48 hours after the surgery
Numerical rating scale (NRS)
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.

Full Information

First Posted
January 21, 2020
Last Updated
March 14, 2021
Sponsor
Seoul National University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT04239794
Brief Title
The Influence of Type of Anesthesia on Postoperative Pain
Official Title
The Influence of Type of Anesthesia on Postoperative Pain After Laparoscopic Colorectal Cancer Surgery: Multi-center Prospective Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 20, 2020 (Actual)
Primary Completion Date
February 1, 2022 (Anticipated)
Study Completion Date
February 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colo-rectal Cancer, Anesthesia
Keywords
Postoperative pain, Opioid consumption, Intraoperative anesthesia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
468 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Inhalation anesthesia
Arm Type
Active Comparator
Arm Description
Patients are anesthetized with sevoflurane and remifentanil infusion for maintenance of anesthesia during the surgery
Arm Title
Total intravenous anesthesia
Arm Type
Experimental
Arm Description
Patients are anesthetized with target-controlled intravenous infusion of propofol and remifentanil infusion for maintenance of anesthesia during the surgery
Intervention Type
Drug
Intervention Name(s)
Propofol
Other Intervention Name(s)
Propofol 2%
Intervention Description
General anesthesia during the laparoscopic colorectal surgery is achieved by using a target-controlled intravenous infusion of propofol.
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Other Intervention Name(s)
Sevoflurane inhalant product
Intervention Description
General anesthesia during the laparoscopic colorectal surgery is achieved by using an inhalation agent (Sevoflurane).
Primary Outcome Measure Information:
Title
Postoperative 24 h opioid consumption
Description
Cumulative opioid consumption for pain control 24 hours after the surgery
Time Frame
24 hours after the surgery
Secondary Outcome Measure Information:
Title
Postoperative 48 h opioid consumption
Description
Cumulative opioid consumption for pain control 48 hours after the surgery
Time Frame
48 hours after the surgery
Title
Numerical rating scale (NRS)
Description
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.
Time Frame
24 and 48 hours after the surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jin-Tae Kim, PhD
Phone
+82-2-2072-3592
Email
jintae73@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Susie Yoon, MD
Phone
+82-2-2072-7361
Email
susiey87@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin-Tae Kim, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin-Tae Kim, PhD
Phone
+82-2-2072-3295
Email
jintae73@gmail.com
Facility Name
Seoul Metropolitan Government Seoul National University Boramae Medical Center
City
Seoul
ZIP/Postal Code
07061
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tae Kyong Kim, PhD
Phone
+82-2-870-2177
Email
ktkktk@gmail.com
Facility Name
Seoul National University Bundang Hospital
City
Seoul
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bon-Wook Koo, MD
Phone
+82-31-787-2034
Email
tendong2@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30075537
Citation
Wong SSC, Choi SW, Lee Y, Irwin MG, Cheung CW. The analgesic effects of intraoperative total intravenous anesthesia (TIVA) with propofol versus sevoflurane after colorectal surgery. Medicine (Baltimore). 2018 Aug;97(31):e11615. doi: 10.1097/MD.0000000000011615.
Results Reference
background

Learn more about this trial

The Influence of Type of Anesthesia on Postoperative Pain

We'll reach out to this number within 24 hrs