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Clinical 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). 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).


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT05526794
Study type Observational [Patient Registry]
Source Bursa Yüksek Ihtisas Education and Research Hospital
Contact
Status Completed
Phase
Start date January 1, 2022
Completion date August 1, 2022

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