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CompletedNCT05526794

Anesthesia Methods on Percutaneous Kyphoplasty

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

Status
Completed
Phase
Study type
Observational
Enrollment
66 (actual)
Sponsor
Bursa Yuksek Ihtisas Training and Research Hospital · Other Government
Sex
All
Age
18 Years – 100 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREAnalgesic consumption1 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.

Timeline

Start date
2022-01-01
Primary completion
2022-07-01
Completion
2022-08-01
First posted
2022-09-02
Last updated
2022-09-02

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT05526794. Inclusion in this directory is not an endorsement.

Anesthesia Methods on Percutaneous Kyphoplasty (NCT05526794) · Clinical Trials Directory