The Influence of Type of Anesthesia on Postoperative Pain

Not Applicable

Active, not recruiting

• Conditions: Colo-rectal Cancer; Anesthesia
• Interventions: Drug: Sevoflurane; Drug: Propofol

• Registration Number: NCT04239794
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Study First Submitted: 2020-01-21
• Study First Submitted QC: 2020-01-21
• Study First Posted: 2020-01-27
• Study Start: 2020-02-20
• Status Verified: 2023-12
• Primary Completion: 2023-12-19
• Last Update Submitted: 2023-12-21
• Last Update Posted: 2023-12-22
• Study Completion: 2024-01-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 468

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Inhalation anesthesia	Sevoflurane	Patients are anesthetized with sevoflurane and remifentanil infusion for maintenance of anesthesia during the surgery
Total intravenous anesthesia	Propofol	Patients are anesthetized with target-controlled intravenous infusion of propofol and remifentanil infusion for maintenance of anesthesia during the surgery

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Postoperative 48 h opioid consumption	48 hours after the surgery	Cumulative opioid consumption for pain control 48 hours after the surgery
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.

Trial Locations

Locations (3)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Bundang Hospital; 🇰🇷 Seoul, Korea, Republic of

Seoul Metropolitan Government Seoul National University Boramae Medical Center; 🇰🇷 Seoul, Korea, Republic of