Clinical trial NCT05526794: Anesthesia Methods on Percutaneous Kyphoplasty
Official title: Evaluation of Anesthesia Methods in Patients Undergoing Percutaneous Kyphoplasty: A Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vertebral Fracture
Keywords: percutan kyphoplasty
Vertebroplasty
Lead sponsor: Bursa Yüksek İhtisas Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2022-09-02
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 18-100 aged kyphoplasty patients

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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative Visual Analog Scala (VAS) values
timeFrame: VAS values at postoperative 24 hours
Secondary outcomes:
measure: Analgesic consumption
timeFrame: postoperative 24 hours after surgery
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Bursa Training and Research Hospital
Study officials:
affiliation: Bursa Yüksek İhtisas Education and Research Hospital
name: Tuğba T Onur, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Bursa Yüksek İhtisas Education and Research Hospital
name: Ümran Ü Karaca, MD
role: STUDY_CHAIR
affiliation: Bursa Yüksek İhtisas Education and Research Hospital
name: Asiye A Demirel, MD
role: STUDY_CHAIR
affiliation: Bursa Yüksek İhtisas Education and Research Hospital
name: Şeyda Efsun ŞE Özgünay, Assoc Prof
role: STUDY_CHAIR
affiliation: Bursa Medicabil Hospital
name: Anıl A Onur, MD
role: STUDY_CHAIR
References: