Anesthesia Methods on Percutaneous Kyphoplasty

Vertebral Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05526794
• Other study ID #: 2021-KAEK-25 2021/12-09
• Status: Completed
• Start date: January 1, 2022
• Est. completion date: August 1, 2022

Study information

• Verified date: August 2022
• Source: Bursa Yüksek Ihtisas Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: August 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Fractures
• Vertebral Fracture

Intervention

Procedure:
• Analgesic 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.

Locations

Country	Name	City	State
Turkey	Bursa Training and Research Hospital	Bursa

Sponsors (1)

Lead Sponsor	Collaborator
Bursa Yüksek Ihtisas Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	VAS values at postoperative 24 hours
Secondary	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.	postoperative 24 hours after surgery