Monitoring pain levels during major abdominal surgery to improve patient care
Impact of Intraoperative Non-invasive Analgesia Monitoring Using Nociception Level Index on Patient Management
This study is testing if using a new pain monitoring tool during major abdominal surgery can help reduce the need for opioids and improve recovery for patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Iuliu Hatieganu University of Medicine and Pharmacy Academic / other |
| Locations | 1 site (Cluj-Napoca, Cluj) |
| Trial ID | NCT06804434 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of using the Nociception Level Index (NOL) to guide pain management during major abdominal surgeries. It aims to determine how NOL monitoring can influence the administration of intravenous lidocaine and reduce opioid requirements for patients. The study will assess the impact of this multimodal analgesic approach on postoperative outcomes within the first 24 hours after surgery. By comparing traditional pain management techniques with NOL-guided strategies, the trial seeks to enhance patient recovery and comfort.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old undergoing surgery for gastric, hepatobiliary, or pancreatic neoplasia with an ASA score of I-III.
Not a fit: Patients who may not benefit include those with chronic pain, severe neurological disabilities, or those requiring emergency surgery.
Why it matters
Potential benefit: If successful, this approach could significantly reduce opioid consumption and improve recovery times for patients undergoing major abdominal surgery.
How similar studies have performed: Other studies have shown promise in using nociception monitoring for pain management, indicating that this approach may lead to improved outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * age \> 18 years * ASA score I-III * surgery for gastric or hepatobiliary or pancreatic neoplasia Exclusion Criteria: * pregnancy * lactation * neuraxial or regional anesthesia * chronic treatment with drugs that can influence autonomic nervous system * diuretics or nitroglycerin administration on the day of surgery * severe neurological disability * severe hemodynamic instability * chronic pain * chronic opioid treatment * allergy to any of the study drugs * severe untreated disease or organ failure * pacemaker * emergency surgery * patient refusal to participate
Where this trial is running
Cluj-Napoca, Cluj
- Regional Gastroenterology and Hepatology Institute Octavian Fodor — Cluj-Napoca, Cluj, Romania (Recruiting)
Study contacts
- Study coordinator: Cristiana Osoian
- Email: osoiancris@yahoo.com
- Phone: +40743352189
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.