Effect of Erector Spinae Plane Block in Patients Scheduled for Kyphoplasty

Erector Spinae Plane Block Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05970380
• Other study ID #: Kyphoplasty
• Status: Recruiting
• Start date: June 20, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: August 2023
• Source: Bozyaka Training and Research Hospital
• Contact: Halide H Sahinkaya, MD
• Phone: +905058892157
• Email: drhhande[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 30, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Erector Spinae Plane Block

Intervention

Other:
• Erector spinae plane block
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.
• Local anesthesia
Local anesthetic solution (20 mL 0.25% bupivacaine) will be given extrapedicular part of the fractured vertebra by the surgeon.

Locations

Country	Name	City	State
Turkey	Izmir Bozyaka Training and Research Hospital	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Bozyaka Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Demir U, Taskin O. Retrospective Comparison of Anesthetic Methods for Percutaneous Balloon Kyphoplasty Surgery: General Anesthesia and Erector Spinae Plane Block. Medicina (Kaunas). 2023 Jan 27;59(2):240. doi: 10.3390/medicina59020240. — View Citation

Ge C, Wu X, Gao Z, Xu Z, Hao D, Dong L. Comparison of different anesthesia modalities during percutaneous kyphoplasty of osteoporotic vertebral compression fractures. Sci Rep. 2021 May 27;11(1):11102. doi: 10.1038/s41598-021-90621-9. — View Citation

Verduzco LA. Erector spinae plane block as primary anesthetic for kyphoplasty. J Clin Anesth. 2020 May;61:109670. doi: 10.1016/j.jclinane.2019.109670. Epub 2019 Nov 26. No abstract available. — View Citation

Wu AM, Lin ZK, Ni WF, Chi YL, Xu HZ, Wang XY, Huang QS. The existence of intravertebral cleft impact on outcomes of nonacute osteoporotic vertebral compression fractures patients treated by percutaneous kyphoplasty: a comparative study. J Spinal Disord Tech. 2014 May;27(3):E88-93. doi: 10.1097/BSD.0b013e31829142bf. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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