Anesthesia Methods on Percutaneous Kyphoplasty

Completed

• Conditions: Vertebral Fracture
• Interventions: Procedure: Analgesic consumption

• Registration Number: NCT05526794
• Lead Sponsor: Bursa Yüksek İhtisas Education and Research Hospital

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.

Study Timeline

• Study Start: 2022-01-01
• Primary Completion: 2022-07-01
• Status Verified: 2022-08
• Study Completion: 2022-08-01
• Study First Submitted: 2022-08-25
• Study First Submitted QC: 2022-08-31
• Last Update Submitted: 2022-08-31
• Study First Posted: 2022-09-02
• Last Update Posted: 2022-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 3	Analgesic consumption	Peripheral Block \[Erector Spina Plane Block (ESPB), and Paravertebral Block (PVB)
Group 1	Analgesic consumption	General anesthesia or sedation
Group 2	Analgesic consumption	Central Block (Spinal and Epidural Anesthesia

Primary Outcome Measures

Name	Time	Method
Postoperative Visual Analog Scala (VAS) values	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 Outcome Measures

Name	Time	Method
Analgesic consumption	postoperative 24 hours after surgery	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.

Trial Locations

Locations (1)

Bursa Training and Research Hospital; 🇹🇷 Bursa, Turkey