Monitoring postoperative pain after lumbar spine surgery using a heart-rate based pain index

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized parallel-group trial enrolls adults aged 18–65 undergoing elective lumbar spine surgery and assigns them to either bilateral ultrasound-guided erector spinae plane block (ESPB) or intravenous multimodal analgesia. Postoperative pain will be followed with serial Analgesia Nociception Index (ANI) measurements at predefined intervals up to 24 hours, alongside clinical Visual Analog Scale (VAS) scores, total opioid consumption in the first 24 hours, hemodynamic data, and adverse events. The primary outcome is a comparison of early postoperative ANI values between the two groups, with secondary outcomes including VAS scores, opioid requirements, and incidence of analgesia-related side effects. The protocol uses objective heart-rate variability monitoring together with standard clinical measures to determine which analgesic strategy provides better early postoperative pain control.

Why it matters

Who can join: the full rules

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

Where it's running

• Akdeniz University Faculty of Medicine Hospital
  Antalya, Antalya, Turkey (Türkiye) Recruiting

Study contacts

• Principal investigator: Neval Boztuğ, MD — Akdeniz University
• Study coordinator: Ayşe Tekin, MD
• Email: aysesstekin@gmail.com
• Phone: +905376180290

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.