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Clinical Trials in Turkey / NCT07455565
Recruiting Not applicable

Postoperative Pain Monitoring With ANI in Lumbar Spine Surgery

NCT07455565 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2025-12-16
Last updated
2026-03-06

Condition(s) studied

Postoperative PainLumbar Spine Surgery

Investigational drug(s) / intervention(s)

Erector Spinae Plane BlockIntravenous Multimodal Analgesia →

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.

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.

Study 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

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: * Age between 18 and 65 years * ASA physical status I-II * Scheduled for elective lumbar spine surgery * Ability to provide informed consent Exclusion Criteria: * Known allergy to study medications * Coagulation disorders * Infection at the block site * Severe cardiovascular disease * Pregnancy * Inability to understand the study protocol

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Akdeniz University Faculty of Medicine Hospital Antalya Antalya Recruiting

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Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07455565 on ClinicalTrials.gov ↗ ← All trials in Turkey