Health TrialsbyHealthPanel

Postoperative Pain Monitoring With ANI in Lumbar Spine Surgery

ConditionsPostoperative PainLumbar Spine Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAkdeniz University Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Age between 18 and 65 years

ASA physical status I-II

Scheduled for elective lumbar spine surgery

Ability to provide informed consent

Disqualifiers

Known allergy to study medications

Coagulation disorders

Infection at the block site

Severe cardiovascular disease

Trial design

Design model

Parallel

Treatments tested in this trial

  • Erector Spinae Plane Block

    Procedure/Surgery

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

  • 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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Erector Spinae Plane BlockExperimental treatment 1 intervention
Group B: Intravenous Multimodal AnalgesiaActive comparator 1 intervention

Trial outcomes

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.

Time frame
From 0 minutes to 24 hours postoperatively

Secondary outcomes

1

Visual Analog Scale (VAS) Pain Score

Pain intensity assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate worse pain.

Time frame
From 0 minutes to 24 hours postoperatively
2

Postoperative Nausea

Incidence of postoperative nausea within 24 hours after surgery.

Time frame
Within 24 hours postoperatively.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Akdeniz University Hospital

Lead sponsor

Source ClinicalTrials.gov
Apply now