Postoperative Pain, Lumbar Spine Surgery
Conditions
Keywords
Analgesia Nociception Index, Erector Spinae Plane Block, Postoperative Pain, Lumbar Spine Surgery, Multimodal Analgesia, Randomized Controlled Trial
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.
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.
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.
Sponsors
Akdeniz University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Analgesia Nociception Index (ANI) | 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
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale (VAS) Pain Score | From 0 minutes to 24 hours postoperatively | Pain intensity assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate worse pain. |
| Postoperative Nausea | Within 24 hours postoperatively. | Incidence of postoperative nausea within 24 hours after surgery. |
Countries
Turkey (Türkiye)
Contacts
CONTACTAyşe Tekin, MD
CONTACTNeval Boztuğ, MD
PRINCIPAL_INVESTIGATORNeval Boztuğ, MD
Akdeniz University
Outcome results
None listed