Comparison Of Postoperative Analgesic Efficacy Using Analgesia Nociception Index Monitoring In Patients Undergoing Elective Lumbar Spine Surgery: A Randomized Parallel-Group Study
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Akdeniz University Hospital
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Analgesia Nociception Index (ANI)
Overview
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.
Detailed Description
Effective postoperative pain management is essential in lumbar spine surgery to improve patient comfort and recovery. Traditional pain assessment methods rely on subjective scales, such as the Visual Analog Scale (VAS). The Analgesia Nociception Index (ANI) is a non-invasive monitoring tool based on heart rate variability analysis that provides an objective assessment of the balance between nociception and analgesia.
This randomized parallel-group clinical study compares two analgesic strategies in adult patients undergoing elective lumbar spine surgery. Participants are randomly assigned using a simple lottery method to receive either ultrasound-guided bilateral erector spinae plane block (ESPB) or intravenous multimodal analgesia.
ANI values are recorded at postoperative 0, 15, 30, 45, 60, 90, 120, and 180. minutes, and at 6, 12, and 24. hours. These measurements are evaluated together with clinical pain scores, total opioid consumption within 24 hours, hemodynamic parameters, and adverse events.
The primary objective is to compare ANI values between the two groups during the early postoperative period. Secondary objectives include comparison of VAS scores, opioid requirements, and incidence of analgesia-related adverse effects.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age between 18 and 65 years
- •ASA physical status I-II
- •Scheduled for elective lumbar spine surgery
- •Ability to provide informed consent
Exclusion Criteria
- •Known allergy to study medications
- •Coagulation disorders
- •Infection at the block site
- •Severe cardiovascular disease
- •Pregnancy
- •Inability to understand the study protocol
Arms & Interventions
Erector 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.
Intervention: Erector Spinae Plane Block (Procedure)
Intravenous Multimodal Analgesia
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.
Intervention: Intravenous Multimodal Analgesia (Drug)
Outcomes
Primary Outcomes
Analgesia Nociception Index (ANI)
Time Frame: From 0 minutes to 24 hours postoperatively
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.
Secondary Outcomes
- Visual Analog Scale (VAS) Pain Score(From 0 minutes to 24 hours postoperatively)
- Postoperative Nausea(Within 24 hours postoperatively.)
Investigators
Ayşe Tekin
Research Assistant, Department of Anesthesiology
Akdeniz University Hospital