Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID07455565

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

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

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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

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