RecruitingNot ApplicableNCT07455565

Postoperative Pain Monitoring With ANI in Lumbar Spine Surgery

Comparison Of Postoperative Analgesic Efficacy Using Analgesia Nociception Index Monitoring In Patients Undergoing Elective Lumbar Spine Surgery: A Randomized Parallel-Group Study


Sponsor

Akdeniz University Hospital

Enrollment

100 participants

Start Date

Dec 16, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria4

  • Age between 18 and 65 years
  • ASA physical status I-II
  • Scheduled for elective lumbar spine surgery
  • Ability to provide informed consent

Exclusion Criteria6

  • Known allergy to study medications
  • Coagulation disorders
  • Infection at the block site
  • Severe cardiovascular disease
  • Pregnancy
  • Inability to understand the study protocol

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Interventions

PROCEDUREErector Spinae Plane Block

Ultrasound-guided bilateral erector spinae plane block performed at the thoracolumbar level using a total of 200 mg bupivacaine for postoperative analgesia.

DRUGIntravenous Multimodal Analgesia

Intravenous administration of paracetamol 1 g, morphine 0.1 mg/kg, dexamethasone 8 mg, and ketamine 0.5 mg/kg bolus followed by 0.3 mg/kg/h infusion for postoperative pain management.


Locations(1)

Akdeniz University Faculty of Medicine Hospital

Antalya, Antalya, Turkey (Türkiye)

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