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NCT04239794 Clinical Trial

The Influence of Type of Anesthesia on Postoperative Pain

Anesthesia Clinical Trial

Official title:
The Influence of Type of Anesthesia on Postoperative Pain After Laparoscopic Colorectal Cancer Surgery: Multi-center Prospective Randomized Controlled Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04239794
Other study ID # TIVA-IA-Pain
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date February 20, 2020
Est. completion date January 31, 2024

Study information
Verified date December 2023
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 468
Est. completion date January 31, 2024
Est. primary completion date December 19, 2023
Accepts healthy volunteers No
Gender All
Age group 19 Years to 80 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Propofol
General anesthesia during the laparoscopic colorectal surgery is achieved by using a target-controlled intravenous infusion of propofol.
• Sevoflurane
General anesthesia during the laparoscopic colorectal surgery is achieved by using an inhalation agent (Sevoflurane).

Locations
Country Name City State
Korea, Republic of Seoul Metropolitan Government Seoul National University Boramae Medical Center Seoul
Korea, Republic of Seoul National University Bundang Hospital Seoul
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Postoperative 24 h opioid consumption Cumulative opioid consumption for pain control 24 hours after the surgery 24 hours after the surgery
Secondary Postoperative 48 h opioid consumption Cumulative opioid consumption for pain control 48 hours after the surgery 48 hours after the surgery
Secondary 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. 24 and 48 hours after the surgery
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