Postoperative Pain Monitoring With ANI in Lumbar Spine Surgery

NCT07455565 | Recruiting

• 2 other identifiers: AU-ANES-ANI-2025-360BAP Project No: 6976
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Pain; Lumbar Spine Surgery

Keywords

Analgesia Nociception Index; Erector Spinae Plane Block; Postoperative Pain; Lumbar Spine Surgery; Multimodal Analgesia; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Analgesia Nociception Index (ANI)

  Analgesia Nociception Index (ANI) measured using the ANI monitor. The ANI ranges from 0 to 100. Higher values indicate greater parasympathetic tone and lower nociceptive stimulation, whereas lower values indicate higher nociceptive stimulation.

  From 0 minutes to 24 hours postoperatively

Secondary Outcomes (2)

• Visual Analog Scale (VAS) Pain Score

  From 0 minutes to 24 hours postoperatively

• Postoperative Nausea

  Within 24 hours postoperatively.

Study Arms (2)

Erector Spinae Plane Block

EXPERIMENTAL

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

Procedure: Erector Spinae Plane Block

Intravenous Multimodal Analgesia

ACTIVE COMPARATOR

Intravenous multimodal analgesia including 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.

Drug: Intravenous Multimodal Analgesia

Interventions

Erector Spinae Plane Block PROCEDURE

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

Erector Spinae Plane Block

Intravenous Multimodal Analgesia DRUG

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.

Also known as: IV Multimodal Analgesia

Intravenous Multimodal Analgesia

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Akdeniz University Hospital: lead

Study Sites (1)

Akdeniz University Faculty of Medicine Hospital

Antalya, Antalya, 0707, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Neval Boztuğ, MD

  Akdeniz University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ayşe Tekin, MD

CONTACT

+905376180290; aysesstekin@gmail.com

Neval Boztuğ, MD

CONTACT

+905327995810; nboztuğ@akdeniz.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant, Department of Anesthesiology

Model Details: Participants are randomly assigned using a simple lottery method to one of two parallel groups: ultrasound-guided bilateral erector spinae plane block (ESPB) or intravenous multimodal analgesia. Outcomes are compared between groups during the early postoperative period.

Study Record Dates

• First Submitted: February 25, 2026
• First Posted: March 6, 2026
• Study Start: December 16, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)