Postoperative Pain Monitoring With ANI in Lumbar Spine Surgery
NCT07455565 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2026-03-06
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.
Conditions
- Postoperative Pain
- Lumbar Spine Surgery
Interventions
- PROCEDURE
-
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.
- DRUG
-
Intravenous Multimodal Analgesia
Intravenous administration of 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 for postoperative pain management.
Sponsors & Collaborators
-
Akdeniz University Hospital
lead OTHER
Principal Investigators
-
Neval Boztuğ, MD · Akdeniz University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-12-16
- Primary Completion
- 2026-12-31
- Completion
- 2026-12-31
Countries
- Turkey (Türkiye)
Study Locations
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