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Anesthesia Methods on Percutaneous Kyphoplasty

Evaluation of Anesthesia Methods in Patients Undergoing Percutaneous Kyphoplasty: A Prospective Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05526794
Enrollment
66
Registered
2022-09-02
Start date
2022-01-01
Completion date
2022-08-01
Last updated
2022-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vertebral Fracture

Keywords

percutan kyphoplasty, Vertebroplasty

Brief 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). 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.

Interventions

PROCEDUREAnalgesic consumption

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.

Sponsors

Bursa Yuksek Ihtisas Training and Research Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

* 18-100 ages kyphoplasty surgery patients * written consent form received

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative Visual Analog Scala (VAS) valuesVAS values at postoperative 24 hoursVAS is a scala between 0-10 points. If there is no pain it means 0; very severe pain is 10 points.

Secondary

MeasureTime frameDescription
Analgesic consumptionpostoperative 24 hours after surgeryIn 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026