Vertebral FractureNCT05526794
Anesthesia Methods on Percutaneous Kyphoplasty
An observational study of Vertebral Fracture, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this research is to examine the effects of the anesthesia method and preoperative characteristics on postoperative results and complications in patients who underwent percutaneous kyphoplasty (PKP). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Vertebral Fracture
- What is being tested?
- Analgesic consumption
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2022to 1 Aug 2022
- How long will I take part?
- 1 Day
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 18-100 aged kyphoplasty patients
Who may be able to join
- 18-100 ages kyphoplasty surgery patients
- written consent form received
Who cannot join
- The patient's unwillingness to participate in the study
- inability to communicate with the patient
- the patient does not speak Turkish,
- previous CVO, presence of cognitive impairment
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bursa Training and Research Hospital
Bursa, 16600
About this study
Official title: Evaluation of Anesthesia Methods in Patients Undergoing Percutaneous Kyphoplasty: A Prospective Study
The aim of this research is to examine the effects of the anesthesia method and preoperative characteristics on postoperative results and complications in patients who underwent percutaneous kyphoplasty (PKP).
Method: Patients were split into three groups according to anesthesia methods: (1) General Anesthesia (Sedation), (2) Central Block (Spinal and Epidural Anesthesia), (3) Peripheral Block [Erector Spina Plane Block (ESPB), and Paravertebral Block (PVB)]. Patients' pain values, hemodynamic parameters, additional need for sedation, and perioperative and postoperative complications were recorded prospectively together with Visual Pain Scales (VAS).
Read the detailed description
Demographic characteristics (body mass index [BMI], gender, age, ASA use, pain values [VAS] before surgery, analgesic use habits, anesthesia technique chosen by anesthesiologist blind to the study, perioperative hemodynamic parameters, additional opioid during surgery, parol? or anesthetic need, perioperative complications [patients who willingly stopped the procedure during the intervention, moaning, hypotension, hypertension, bradycardia, respiratory depression, desaturation and need for mask ventilation] were taken from the records of the individuals with the treatment of PKP between 01/22-07/22 after the approval of the SBÜ Bursa Yüksek İhtisas EAH Ethics Committee (2021-KAEK-25 2021/12-09) and the patient's consent. In addition, the first mobilization time, additional analgesic need, total amount of analgesic used in 24 hours, discharge time, VAS values at 2, 6,12, and 18 hours, complications (nausea, vomiting, pain, delirium, respiratory insufficiency, infection, deep vein thrombosis, pulmonary embolus, need for re-operation, need for intensive care or mechanic ventilator) were also recorded.
- Conditions
- Vertebral Fracture
- Being tested
- Analgesic consumption
- Keywords
- percutan kyphoplasty, Vertebroplasty
- Medical subject headings
- Spinal Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analgesic consumptionProcedure or surgery
1 gr iv paracetamol for all patients with a VAS value of 2 or 3; for 4 and over, 1.5 mg/kg iv tramadol was administered additionally.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | General anesthesia or sedation Receives: Procedure: Analgesic consumption | |
| Group 2 | Central Block (Spinal and Epidural Anesthesia Receives: Procedure: Analgesic consumption | |
| Group 3 | Peripheral Block [Erector Spina Plane Block (ESPB), and Paravertebral Block (PVB) Receives: Procedure: Analgesic consumption |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Visual Analog Scala (VAS) values
VAS is a scala between 0-10 points. If there is no pain it means 0; very severe pain is 10 points.
Measured: VAS values at postoperative 24 hours
Secondary outcomes (1)
Analgesic consumption
In all times that VAS is recorded;1 gr iv paracetamol for all patients with a VAS value of 2 or 3; for 4 and over, 1.5 mg/kg iv tramadol was administered additionally.
Measured: postoperative 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start1 Jan 2022
- Primary completion1 Jul 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vertebral FractureStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 66 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Tugba Onur, Bursa Yuksek Ihtisas Training and Research Hospital
- Investigators
- Tuğba T Onur, MD, Principal investigator, Bursa Yuksek Ihtisas Training and Research HospitalÜmran Ü Karaca, MD, Study chair, Bursa Yuksek Ihtisas Training and Research HospitalAsiye A Demirel, MD, Study chair, Bursa Yuksek Ihtisas Training and Research HospitalŞeyda Efsun ŞE Özgünay, Assoc Prof, Study chair, Bursa Yuksek Ihtisas Training and Research HospitalAnıl A Onur, MD, Study chair, Bursa Medicabil Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05526794
- Sponsor's protocol ID
- 2021-KAEK-25 2021/12-09
- Status last verified
- Aug 2022
- First submitted
- 25 Aug 2022
- Last updated
- 2 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: With the written consent of the patients and the approval of the ethics committee, I do not intend to share their special circumstances and information other than the study data.
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Anesthesia Methods in Patients Undergoing Percutaneous Kyphoplasty: A Prospective Study
- ClinicalTrials.gov ID
- NCT05526794
- Acronym / sponsor ID
- 2021-KAEK-25 2021/12-09
- Conditions
- Vertebral Fracture
- Keywords
- percutan kyphoplasty, Vertebroplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research HospitalOther government
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 2 Sep 2022 (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.
The aim of this research is to examine the effects of the anesthesia method and preoperative characteristics on postoperative results and complications in patients who underwent percutaneous kyphoplasty (PKP).
Method: Patients were split into three groups according to anesthesia methods: (1) General Anesthesia (Sedation), (2) Central Block (Spinal and Epidural Anesthesia), (3) Peripheral Block [Erector Spina Plane Block (ESPB), and Paravertebral Block (PVB)]. Patients' pain values, hemodynamic parameters, additional need for sedation, and perioperative and postoperative complications were recorded prospectively together with Visual Pain Scales (VAS).
Detailed description
Demographic characteristics (body mass index [BMI], gender, age, ASA use, pain values [VAS] before surgery, analgesic use habits, anesthesia technique chosen by anesthesiologist blind to the study, perioperative hemodynamic parameters, additional opioid during surgery, parol? or anesthetic need, perioperative complications [patients who willingly stopped the procedure during the intervention, moaning, hypotension, hypertension, bradycardia, respiratory depression, desaturation and need for mask ventilation] were taken from the records of the individuals with the treatment of PKP between 01/22-07/22 after the approval of the SBÜ Bursa Yüksek İhtisas EAH Ethics Committee (2021-KAEK-25 2021/12-09) and the patient's consent. In addition, the first mobilization time, additional analgesic need, total amount of analgesic used in 24 hours, discharge time, VAS values at 2, 6,12, and 18 hours, complications (nausea, vomiting, pain, delirium, respiratory insufficiency, infection, deep vein thrombosis, pulmonary embolus, need for re-operation, need for intensive care or mechanic ventilator) were also recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Procedure: Analgesic consumptionGeneral anesthesia or sedation |
| Group 2 | – | Procedure: Analgesic consumptionCentral Block (Spinal and Epidural Anesthesia |
| Group 3 | – | Procedure: Analgesic consumptionPeripheral Block [Erector Spina Plane Block (ESPB), and Paravertebral Block (PVB) |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 18-100 aged kyphoplasty patients
Key inclusion criteria (2 listed)
- 18-100 ages kyphoplasty surgery patients
- written consent form received
Key exclusion criteria (4 listed)
- The patient's unwillingness to participate in the study
- inability to communicate with the patient
- the patient does not speak Turkish,
- previous CVO, presence of cognitive impairment
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 |
|---|---|---|
| Analgesic consumption1 gr iv paracetamol for all patients with a VAS value of 2 or 3; for 4 and over, 1.5 mg/kg iv tramadol was administered additionally. | Procedure or surgery | Group 1, Group 2, Group 3 |
Primary outcome
Postoperative Visual Analog Scala (VAS) values
Time frame: VAS values at postoperative 24 hours
VAS is a scala between 0-10 points. If there is no pain it means 0; very severe pain is 10 points.
1 secondary outcome
Analgesic consumption
Time frame: postoperative 24 hours after surgery
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 2 Sep 2022.
- Individual participant dataSharing planned: No. With the written consent of the patients and the approval of the ethics committee, I do not intend to share their special circumstances and information other than the study data.
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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.
Tuğba T Onur, MD principal investigator
Bursa Yuksek Ihtisas Training and Research Hospital
Ümran Ü Karaca, MD study chair
Bursa Yuksek Ihtisas Training and Research Hospital
Asiye A Demirel, MD study chair
Bursa Yuksek Ihtisas 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 Vertebral Fracture, run by Bursa Yuksek Ihtisas 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 2 inclusion and 4 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 2 Sep 2022. 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?
Postoperative Visual Analog Scala (VAS) values (time frame: VAS values at postoperative 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Sep 2022.