Monitoring postoperative pain after lumbar spine surgery using a heart-rate based pain index
Comparison Of Postoperative Analgesic Efficacy Using Analgesia Nociception Index Monitoring In Patients Undergoing Elective Lumbar Spine Surgery: A Randomized Parallel-Group Study
This study tests whether an ultrasound-guided erector spinae plane block or intravenous multimodal pain medicines give better pain control for adults having elective lumbar spine surgery, using pain scores and the Analgesia Nociception Index.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Akdeniz University Hospital Academic / other |
| Locations | 1 site (Antalya, Antalya) |
| Trial ID | NCT07455565 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 18–65 with ASA physical status I–II scheduled for elective lumbar spine surgery who can provide informed consent and have no contraindications to regional block or study medications are ideal candidates.
Not a fit: Patients with coagulation disorders, infection at the block site, severe cardiovascular disease, pregnancy, or inability to understand or follow the protocol are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the preferred approach could reduce postoperative pain and opioid use after lumbar spine surgery, improving patient comfort and recovery.
How similar studies have performed: Prior smaller studies have reported that ESPB can reduce postoperative pain and ANI can provide objective nociception data, but randomized comparisons against standardized IV multimodal regimens remain limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Antalya, Antalya
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.