Comparison Of Postoperative Analgesic Efficacy Using Analgesia Nociception Index Monitoring In Patients Undergoing Elective Lumbar Spine Surgery: A Randomized Parallel-Group Study
Status: Recruiting
Location: See location...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This study aims to compare two different pain management methods in patients undergoing elective lumbar spine surgery. Patients are randomly assigned to receive either an ultrasound-guided erector spinae plane block (ESPB) or intravenous multimodal analgesia. Postoperative pain will be assessed using both clinical pain scores and the Analgesia Nociception Index (ANI), a non-invasive monitoring system that evaluates pain-related responses based on heart rate variability. The goal of this study is to determine which method provides better postoperative pain control.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• Age between 18 and 65 years
• ASA physical status I-II
• Scheduled for elective lumbar spine surgery
• Ability to provide informed consent
Locations
Other Locations
Turkey
Akdeniz University Faculty of Medicine Hospital
RECRUITING
Antalya
Contact Information
Primary
Ayşe Tekin, MD
aysesstekin@gmail.com
+905376180290
Backup
Neval Boztuğ, MD
nboztuğ@akdeniz.edu.tr
+905327995810
Time Frame
Start Date: 2025-12-16
Estimated Completion Date: 2026-12
Participants
Target number of participants: 100
Treatments
Experimental: Erector Spinae Plane Block
Ultrasound-guided bilateral erector spinae plane block performed at the thoracolumbar level using a total of 200 mg bupivacaine for postoperative analgesia.
Active_comparator: Intravenous Multimodal Analgesia
Intravenous multimodal analgesia including paracetamol 1 g, morphine 0.1 mg/kg, dexamethasone 8 mg, and ketamine 0.5 mg/kg bolus followed by 0.3 mg/kg/h infusion.
Related Therapeutic Areas
Sponsors
Leads: Akdeniz University Hospital