Actively Recruiting
Comparison of Postoperative Analgesic Efficacy Using Analgesia Nociception Index Monitoring in Patients Undergoing Elective Lumbar Spine Surgery: A Randomized Parallel-Group Study
Led by Akdeniz University Hospital · Updated on 2026-03-06
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying pain management methods for adults undergoing elective lumbar spine surgery. This randomized study compares two approaches: an ultrasound-guided erector spinae plane block (ESPB) and intravenous multimodal analgesia. The goal is to see which method provides better control of postoperative pain using both clinical scores and a monitoring system called the Analgesia Nociception Index (ANI), which measures pain-related responses through heart rate variability. Participants are randomly assigned to one of two groups. One group receives an ultrasound-guided bilateral ESPB with 200 mg of bupivacaine at the thoracolumbar level. The other group receives intravenous multimodal analgesia including paracetamol, morphine, dexamethasone, and ketamine with specified doses and infusion rates. ANI values and clinical pain scores are recorded at multiple time points from immediately after surgery up to 24 hours. During the study, participants will have their pain monitored using ANI at specific intervals along with clinical pain scores, opioid consumption, hemodynamic measurements, and any adverse effects. The primary measure is the ANI from 0 minutes to 24 hours after surgery. Secondary measures include pain scores using the Visual Analog Scale and the incidence of nausea within 24 hours. The study is sponsored by Akdeniz University Hospital and includes adult patients aged 18 to 65 years.
CONDITIONS
Brief Title
Postoperative Pain Monitoring With ANI in Lumbar Spine Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 65 years
- ASA physical status I or II
- Scheduled for elective lumbar spine surgery
- Ability to provide informed consent
You will not qualify if you...
- Known allergy to study medications
- Coagulation disorders
- Infection at the block site
- Severe cardiovascular disease
- Pregnancy
- Inability to understand the study protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 hours postoperatively
Participants undergo elective lumbar spine surgery and receive postoperative pain management with either an erector spinae plane block or intravenous multimodal analgesia.
1 surgery visit and multiple postoperative assessments within 24 hours
Trial Site Locations
Total: 1 location
1
Akdeniz University Faculty of Medicine Hospital
Antalya, Antalya, Turkey (Türkiye), 0707
Actively Recruiting
Research Team
A
Ayşe Tekin, MD
N
Neval Boztuğ, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here