Effect of Erector Spinae Plane Block in Patients Scheduled for Kyphoplasty

Study Overview
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Brief Summary
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Patients, older than 50 years, with vertebral fracture scheduled for percutaneous balloon kyphoplasty will be enrolled for the study. Some patients will be under local anesthesia with sedation and analgesia for the procedure. Some patients will be performed erector spinae plane block with the guidance of ultrasonography for the procedure. The investigators aim to evaluate the intraoperative and postoperative analgesic requirement of patients. Surgeon's and patients' satisfaction will be also evaluated.

Detailed Description
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Patients, older than 50 years, American Society of Anesthesiologists physical status I, II, III and IV and scheduled for percutaneous balloon kyphoplasty due to osteoporotic vertebra fracture will be enrolled for this prospective, observational study. Written consent will be taken from all patients. All patients will be taken to the premedication room. Standard monitorization will be performed with electrocardiography, non-invasive blood pressure and pulse oximeter. A 20 Gauge intravenous (iv) canula will be inserted and 10-20 mg/kg iv crystalloid infusion will be started. According to the neurosurgeon's preference patients will be under local anesthesia with sedation and analgesia or erector spinae plane block and sedation during the procedure. In Group Local Anesthesia (L), local anesthesia with 0.25% 20 mL bupivacaine will be given extrapedicular part of the fractured vertebra by the surgeon. At the same time, intravenous 0.1 mg/kg midazolam, 0.3 mg/kg ketamine and 25-100 mcg/kg/min propofol will be administered to achieve sedation and analgesia. In Group Erector Spinae Plane Block (ESP), bilateral erector spinae plane block will be performed at the level of fractured vertebra with totally 40 mL 0.25% bupivacaine under ultrasound imaging by the anesthesiologist. 20 minutes after administration of the block, the surgical procedure will be started. During the procedure intravenous 0.1 mg/kg midazolam will be administered for sedation. Pain will be assessed with numeric rating scale (NRS). When NRS is 4 or over 4, additional 0.3 mg/kg ketamine and 25-100 mcg/kg/min propofol will be given intravenously. In the postoperative period all patients in groups, NRS will be also used to assess the pain. When NRS is 4 or over 4, 1 gr paracetamol will be given intravenously. If NRS will not be under 4 after 1 hour of paracetamol administration, iv 1 mg/kg tramadol will be given. Postoperative and intraoperative opioid consumption will be assessed to evaluate the effectiveness of erector spinae plane block. Surgeon's and patients satisfaction will be assessed with 5 points Likert's scale; 1: very dissatisfied, 2: dissatisfied, 3: neither dissatisfied or satisfied, 4: satisfied, 5: very satisfied. All outcome measures will be statistically analyzed.

Official Title
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Evaluation of the Effect of Erector Spinae Plane Block on Analgesic Consumption in Patients Scheduled for Percutaneous Balloon Kyphoplasty; Prospective Observational Study

Conditions
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Erector Spinae Plane Block

Intervention / Treatment
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* Other: Erector spinae plane block
* Other: Local anesthesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologists physical status I, II, III, IV Pathologic vertebra fracture Percutaneous balloon kyphoplasty for single vertebrae Exclusion Criteria: Contraindications for plane blocks (bleeding disorder, infection on the injection side) Hemodynamic instability Pregnancy Patient's refusal Vertebra fracture due to trauma Multiple vertebra fractures Procedure under general anesthesia Allergy to local anesthetics

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Local anesthesia<br>Local anesthesia with 0.25% 20 mL bupivacaine will be given extrapedicular part of the fractured vertebra by the surgeon. At the same time, intravenous 0.1 mg/kg midazolam, 0.3 mg/kg ketamine and 25-100 mcg/kg/min propofol will be administered to achieve sedation and analgesia. | Other: Local anesthesia<br>* Local anesthetic solution (20 mL 0.25% bupivacaine) will be given extrapedicular part of the fractured vertebra by the surgeon.<br>|
| ESP Block<br>Bilateral erector spinae plane block will be performed at the level of fractured vertebra with totally 40 mL 0.25% bupivacaine under ultrasound imaging by the anesthesiologist. Intravenous 0.1 mg/kg midazolam will be administered for sedation. | Other: Erector spinae plane block<br>* Local anesthetic solution (40 mL 0.25% bupivacaine totally) will be given bilaterally between the processus transversalis of the fractured vertebra and the erector spinae muscle under ultrasound imaging by an anesthesiologist.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid consumption during surgery | Opioid consumption will be assessed with the need of opioid analgesics and propofol during the surgical procedure. | Within first hour of the surgical procedure | 
| Opioid consumption after surgery | Opioid consumption will be assessed with the need of opioid analgesics after the surgery. | Up to 24 hours after the surgical procedure | 
| Pain during surgical procedure | Pain during the surgical procedure will be assessed by using numeric rating scale (NRS). NRS is between 0 and 10, where 0 is no pain and 10 is the worst pain. When the NRS is 4 or over 4 additional opioid analgesic will be given to the patient intravenously. | Within the first hour of the surgical procedure | 
| Pain after surgical procedure | Pain will be assessed with numeric rating scale (NRS). NRS is between 0 and 10, where 0 is no pain and 10 is the worst pain. When the NRS is 4 or over 4, additional opioid analgesic will be given to the patient intravenously. | Up to 24 hours after the surgical procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgeon's satisfaction | The surgeon will assess the ease of the procedure and patient's comfort during the procedure with Likert's scale; 1: very dissatisfied, 2: dissatisfied, 3: neither dissatisfied or satisfied, 4: satisfied, 5: very satisfied | Within 24 hours of the surgical procedure | 
| Patient's satisfaction | Patient will assess the comfort during intraoperative and postoperative period with Likert's scale 1: very dissatisfied, 2: dissatisfied, 4: neither dissatisfied or satisfied, 4: satisfied, 5: very satisfied | Within 24 hours of the surgical procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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percutaneous balloon kyphoplasty, erector spinae plane block, Postoperative Pain, local anesthesia