Clinical trial NCT05970380: Effect of Erector Spinae Plane Block in Patients Scheduled for Kyphoplasty
Official title: Evaluation of the Effect of Erector Spinae Plane Block on Analgesic Consumption in Patients Scheduled for Percutaneous Balloon Kyphoplasty; Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Erector Spinae Plane Block
Keywords: percutaneous balloon kyphoplasty
erector spinae plane block
Postoperative Pain
local anesthesia
Lead sponsor: Bozyaka Training and Research Hospital
Sponsor class: OTHER
First posted: 2023-08-01
Enrollment: 61
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with pathologic vertebra fracture that is indicated for percutaneous balloon kyphoplasty will be enrolled for the study.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Opioid consumption during surgery
timeFrame: Within first hour of the surgical procedure
measure: Opioid consumption after surgery
timeFrame: Up to 24 hours after the surgical procedure
measure: Pain during surgical procedure
timeFrame: Within the first hour of the surgical procedure
measure: Pain after surgical procedure
timeFrame: Up to 24 hours after the surgical procedure
Secondary outcomes:
measure: Surgeon's satisfaction
timeFrame: Within 24 hours of the surgical procedure
measure: Patient's satisfaction
timeFrame: Within 24 hours of the surgical procedure
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Izmir Bozyaka Training and Research Hospital
Study officials:
affiliation: Izmir Bozyaka Training and Research Hospital
name: Halide H Şahinkaya, MD
role: STUDY_CHAIR
affiliation: Izmir Bozyaka Training and Research Hospital
name: Alper Tabanlı, MD
role: STUDY_CHAIR
References:
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.
citation: 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.
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.
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.