Effect of Erector Spinae Plane Block in Patients Scheduled for Kyphoplasty

NCT05970380 | Completed DMC

• 1 other identifier: Kyphoplasty
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Erector Spinae Plane Block

Keywords

percutaneous balloon kyphoplasty; erector spinae plane block; Postoperative Pain; local anesthesia

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Surgeon's satisfaction

  Within 24 hours of the surgical procedure

• Patient's satisfaction

  Within 24 hours of the surgical procedure

Study Arms (2)

Local anesthesia

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

ESP Block

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

Interventions

Erector spinae plane block OTHER

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.

ESP Block

Local anesthesia OTHER

Local anesthetic solution (20 mL 0.25% bupivacaine) will be given extrapedicular part of the fractured vertebra by the surgeon.

Local anesthesia

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with pathologic vertebra fracture that is indicated for percutaneous balloon kyphoplasty will be enrolled for the study.

You may qualify if:

• American Society of Anesthesiologists physical status I, II, III, IV
• Pathologic vertebra fracture
• Percutaneous balloon kyphoplasty for single vertebrae

You may not qualify if:

• 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

Sponsors & Collaborators

• Bozyaka Training and Research Hospital: lead

Study Sites (1)

Izmir Bozyaka Training and Research Hospital

Izmir, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 31784307 BACKGROUND

• 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.

  PMID: 36837442 BACKGROUND

• 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.

  PMID: 34045557 BACKGROUND

• 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.

  PMID: 23563348 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Anesthesia, Local

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Halide H Şahinkaya, MD

  Izmir Bozyaka Training and Research Hospital

  STUDY CHAIR

• Alper Tabanlı, MD

  Izmir Bozyaka Training and Research Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Anesthesiology Specialist, Clinical Director

Study Record Dates

• First Submitted: July 24, 2023
• First Posted: August 1, 2023
• Study Start: July 25, 2023
• Primary Completion: December 30, 2023
• Study Completion: February 28, 2024
• Last Updated: May 6, 2025

Record last verified: 2025-05

Locations

TU (1)