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| ID | Type | Description | Link |
|---|---|---|---|
| BAP Project No: 6976 | Other Grant/Funding Number | Akdeniz University Scientific Research Projects Coordination Unit (BAP) |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From 0 minutes to 24 hours postoperatively |
| Postoperative Nausea |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ayşe Tekin, MD | Contact | +905376180290 | aysesstekin@gmail.com | |
| Neval Boztuğ, MD | Contact | +905327995810 | nboztuğ@akdeniz.edu.tr |
| Name | Affiliation | Role |
|---|---|---|
| Neval Boztuğ, MD | Akdeniz University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Akdeniz University Faculty of Medicine Hospital | Recruiting | Antalya | Antalya | 0707 | Turkey (Türkiye) |
Individual participant data will not be shared due to institutional policies and patient confidentiality considerations.
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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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.
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| 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. |
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Incidence of postoperative nausea within 24 hours after surgery. |
| Within 24 hours postoperatively. |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |