Postoperative Opioid-related Complications
Conditions
Keywords
Nociception, NoL Index, Opioids, Postoperative Complications, Laparoscopic Surgery
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.
Interventions
DEVICENociception Level (NoL) Monitor
The NoL Monitor (PMD-200) is a multi-parameter sensor device placed on the patient's finger to estimate nociception levels during surgery. It provides continuous, real-time feedback to the anesthesiologist on the patient's nociception, assisting in the optimization of analgesic drug administration. The monitor integrates parameters such as heart rate variability, skin conductance, and other physiological signals to compute the NoL index, which ranges from 0 to 100, with target values between 10 and 25 for optimal nociception management.
Sponsors
Investigation Group Anesthesia, Resuscitation, And Perioperative Medicine of Aragon
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction with Pain Management | At 48 hours postoperatively | Patient satisfaction with pain management will be assessed using a standardized questionnaire. The goal is to compare satisfaction levels between the NoL visible group and the standard monitoring group. |
Contacts
Primary ContactCristian Aragón-Benedí, M.D, Ph.D
Backup ContactAna Pascual-Bellosta, M.D, Ph.D, Prof.
Outcome results
None listed