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Clinical Trials/NCT05526794
NCT05526794
Completed
N/A

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

Bursa Yüksek İhtisas Education and Research Hospital1 site in 1 country66 target enrollmentJanuary 1, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Vertebral Fracture
Sponsor
Bursa Yüksek İhtisas Education and Research Hospital
Enrollment
66
Locations
1
Primary Endpoint
Postoperative Visual Analog Scala (VAS) values
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2022
End Date
August 1, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Bursa Yüksek İhtisas Education and Research Hospital
Responsible Party
Principal Investigator
Principal Investigator

Tugba Onur

Principal İnvestigator

Bursa Yüksek İhtisas Education and Research Hospital

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Analgesic consumption(postoperative 24 hours after surgery)

Study Sites (1)

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