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
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Anesthesia
• Colo-rectal Cancer
• Pain, Postoperative

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