Monitoring Nociception Using NoL Index to Reduce Opioid-Related Complications in Laparoscopic Abdominal Surgery

Not yet recruiting

• Conditions: Postoperative Opioid-related Complications
• Interventions: Device: Nociception Level (NoL) Monitor

• Registration Number: NCT06437743
• Lead Sponsor: Investigation Group Anesthesia, Resuscitation, And Perioperative Medicine of Aragon

Brief Summary

This study aims to determine if optimal intraoperative nociception monitoring using the NoL index can reduce postoperative complications related to opioid use in laparoscopic abdominal surgery. The hypothesis is that guided nociception monitoring decreases opioid-related complications and improves postoperative outcomes.

Detailed Description

The study is a prospective, observational cohort study conducted across multiple centers. It aims to evaluate the impact of intraoperative nociception monitoring on postoperative opioid-related complications. The study will involve two groups of patients undergoing laparoscopic abdominal surgery: one group with visible NoL monitoring and another with non-visible NoL monitoring.

Study Timeline

• Status Verified: 2024-05
• Study First Submitted: 2024-05-25
• Study First Submitted QC: 2024-05-25
• Last Update Submitted: 2024-05-25
• Study First Posted: 2024-05-31
• Last Update Posted: 2024-05-31
• Study Start: 2024-06-01
• Primary Completion: 2025-06-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 282

Inclusion Criteria

• Age ≥ 18 years
• Scheduled for laparoscopic abdominal surgery
• Undergoing balanced general anesthesia
• ASA physical status I-III
• Signed informed consent

Exclusion Criteria

• Refusal to participate
• Communication barriers
• Multimodal, opioid-free, or regional epidural anesthesia
• ASA IV or V
• Pregnant or breastfeeding women
• Open or emergency abdominal surgery
• Post-surgery transfer to ICU or Recovery Unit

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
NoL Visible	Nociception Level (NoL) Monitor	Patients in this group will undergo laparoscopic abdominal surgery with the nociception level (NoL) monitor visible to the anesthesiologist. The NoL monitor provides an estimation of nociception through a multi-parameter sensor placed on the patient's finger. The anesthesiologist will adjust the doses of analgesic drugs based on the values observed on the NoL monitor, aiming to maintain the values between 10 and 25 during the surgery.
NoL Not Visible	Nociception Level (NoL) Monitor	Patients in this group will undergo laparoscopic abdominal surgery with the NoL monitor not visible to the anesthesiologist. The monitor will still be in place and collecting data, but its values will not be displayed during the surgery. The anesthesiologist will manage analgesia based on standard hemodynamic parameters such as heart rate and blood pressure, without access to the NoL values. The intervention includes the same standard anesthetic protocol as the NoL Visible group.

Primary Outcome Measures

Name	Time	Method
Reduction in Postoperative Opioid-Related Complications	From the end of surgery up to 48 hours postoperatively	The primary outcome measure will evaluate the incidence of postoperative opioid-related complications in patients undergoing laparoscopic abdominal surgery. Complications include nausea, vomiting, respiratory depression, and opioid-induced hyperalgesia. The study aims to determine if the use of the NoL monitor to guide intraoperative analgesia reduces these complications compared to standard hemodynamic monitoring.

Secondary Outcome Measures

Name	Time	Method
Postoperative Pain Scores	At 1, 6, 12, 24, and 48 hours postoperatively	Postoperative pain levels will be measured using the Visual Analog Scale (VAS) at various time points post-surgery. The study will compare pain scores between the two groups to evaluate the effectiveness of NoL-guided analgesia.
Length of Hospital Stay	From admission to discharge, up to 7 days postoperatively	This secondary outcome will measure the duration of hospital stay from admission to discharge following surgery. The aim is to determine if NoL-guided analgesia affects the length of hospitalization.
Intraoperative Opioid Consumption	During the surgical procedure	This secondary outcome measure will assess the total amount of opioids administered during surgery. The comparison will be made between the group with visible NoL monitoring and the group with standard hemodynamic monitoring.