NCT07455565 Postoperative Pain Monitoring With ANI in Lumbar Spine Surgery
| NCT ID | NCT07455565 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Akdeniz University Hospital |
| Condition | Postoperative Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-12-16 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2025-12-16 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Neval Boztuğ, MD
PRINCIPAL INVESTIGATOR
Akdeniz University
Frequently Asked Questions
Who can join the NCT07455565 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Postoperative Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07455565 currently recruiting?
Yes, NCT07455565 is actively recruiting participants. Contact the research team at aysesstekin@gmail.com for enrollment information.
Where is the NCT07455565 trial being conducted?
This trial is being conducted at Antalya, Turkey (Türkiye).
Who is sponsoring the NCT07455565 clinical trial?
NCT07455565 is sponsored by Akdeniz University Hospital. The principal investigator is Neval Boztuğ, MD at Akdeniz University. The trial plans to enroll 100 participants.