Erector Spinae Plane BlockNCT05970380
Effect of Erector Spinae Plane Block in Patients Scheduled for Kyphoplasty
An observational study of Erector Spinae Plane Block, run by Bozyaka Training and Research Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Erector Spinae Plane Block
- What is being tested?
- Erector spinae plane block and Local anesthesia
- Type of treatment
- Injection or infusion
- How many people
- 61 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Jul 2023to 28 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with pathologic vertebra fracture that is indicated for percutaneous balloon kyphoplasty will be enrolled for the study.
Who may be able to join
- American Society of Anesthesiologists physical status I, II, III, IV
- Pathologic vertebra fracture
- Percutaneous balloon kyphoplasty for single vertebrae
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Izmir Bozyaka Training and Research Hospital
Izmir
About this study
Official title: Evaluation of the Effect of Erector Spinae Plane Block on Analgesic Consumption in Patients Scheduled for Percutaneous Balloon Kyphoplasty; Prospective Observational Study
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.
Read the 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.
- Conditions
- Erector Spinae Plane Block
- Being tested
- Erector spinae plane block, Local anesthesia
- Keywords
- percutaneous balloon kyphoplasty, erector spinae plane block, Postoperative Pain, local anesthesia
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector spinae plane blockOther
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 anesthesiaOther
Local anesthetic solution (20 mL 0.25% bupivacaine) will be given extrapedicular part of the fractured vertebra by the surgeon.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Erector spinae plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid consumption during surgery
Opioid consumption will be assessed with the need of opioid analgesics and propofol during the surgical procedure.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 24 hours after the surgical procedure
Secondary outcomes (2)
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
Measured: 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
Measured: Within 24 hours of the surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start25 Jul 2023
- Primary completion30 Dec 2023
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Erector Spinae Plane BlockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bozyaka Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Halide Hande Şahinkaya, Bozyaka Training and Research Hospital
- Investigators
- Halide H Şahinkaya, MD, Study chair, Izmir Bozyaka Training and Research HospitalAlper Tabanlı, MD, Study chair, Izmir Bozyaka Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05970380
- Sponsor's protocol ID
- Kyphoplasty
- Status last verified
- May 2025
- First submitted
- 24 Jul 2023
- Last updated
- 6 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31784307Demir 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.
PubMed 36837442Ge 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.
PubMed 34045557Wu 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.
PubMed 23563348
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Erector Spinae Plane Block on Analgesic Consumption in Patients Scheduled for Percutaneous Balloon Kyphoplasty; Prospective Observational Study
- ClinicalTrials.gov ID
- NCT05970380
- Acronym / sponsor ID
- Kyphoplasty
- Conditions
- Erector Spinae Plane Block
- Keywords
- percutaneous balloon kyphoplasty, erector spinae plane block, Postoperative Pain, local anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Bozyaka Training and Research HospitalUniversity, hospital or other
- Study start
- 25 Jul 2023 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 1 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Local anesthesia | – | Other: Local anesthesiaLocal 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. |
| ESP Block | – | Other: Erector spinae plane blockBilateral 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. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with pathologic vertebra fracture that is indicated for percutaneous balloon kyphoplasty will be enrolled for the study.
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists physical status I, II, III, IV
- Pathologic vertebra fracture
- Percutaneous balloon kyphoplasty for single vertebrae
Key exclusion criteria (8 listed)
- Contraindications for plane blocks (bleeding disorder, infection on the injection side)
- Hemodynamic instability
- Pregnancy
- Patient's refusal
- Vertebra fracture due to trauma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Erector spinae plane blockLocal 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. | Other | ESP Block |
| Local anesthesiaLocal anesthetic solution (20 mL 0.25% bupivacaine) will be given extrapedicular part of the fractured vertebra by the surgeon. | Other | Local anesthesia |
Primary outcome
Opioid consumption during surgery
Time frame: Within first hour of the surgical procedure
Opioid consumption will be assessed with the need of opioid analgesics and propofol during the surgical procedure.
Opioid consumption after surgery
Time frame: Up to 24 hours after the surgical procedure
Opioid consumption will be assessed with the need of opioid analgesics after the surgery.
Pain during surgical procedure
Time frame: Within the first hour of the 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.
Pain after surgical procedure
Time frame: Up to 24 hours after the 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.
2 secondary outcomes
Surgeon's satisfaction
Time frame: Within 24 hours of the surgical procedure
Patient's satisfaction
Time frame: Within 24 hours of the surgical procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
- Background: PubMed 31784307Verduzco 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.
- Background: PubMed 36837442Demir 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.
- Background: PubMed 34045557Ge 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.
- Background: PubMed 23563348Wu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Halide H Şahinkaya, MD study chair
Izmir Bozyaka Training and Research Hospital
Alper Tabanlı, MD study chair
Izmir Bozyaka Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Erector Spinae Plane Block, run by Bozyaka Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid consumption during surgery (time frame: Within first hour of the surgical procedure). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05970380, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2025.