Anesthesia Methods on Percutaneous Kyphoplasty

NCT ID: NCT05526794

Last Updated: 2022-09-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 66 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2022-08-01

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.

Conditions

Vertebral Fracture

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Group 1

General anesthesia or sedation

Analgesic consumption

Intervention Type: PROCEDURE

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.

Group 2

Central Block (Spinal and Epidural Anesthesia

Analgesic consumption

Intervention Type: PROCEDURE

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.

Group 3

Peripheral Block \[Erector Spina Plane Block (ESPB), and Paravertebral Block (PVB)

Analgesic consumption

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bursa Yuksek Ihtisas Training and Research Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Tugba Onur

Principal İnvestigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tuğba T Onur, MD

Role: PRINCIPAL_INVESTIGATOR

Bursa Yuksek Ihtisas Training and Research Hospital

Ümran Ü Karaca, MD

Role: STUDY_CHAIR

Bursa Yuksek Ihtisas Training and Research Hospital

Asiye A Demirel, MD

Role: STUDY_CHAIR

Bursa Yuksek Ihtisas Training and Research Hospital

Şeyda Efsun ŞE Özgünay, Assoc Prof

Role: STUDY_CHAIR

Bursa Yuksek Ihtisas Training and Research Hospital

Anıl A Onur, MD

Role: STUDY_CHAIR

Bursa Medicabil Hospital

Locations

Bursa Training and Research Hospital

Bursa, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2021-KAEK-25 2021/12-09

Identifier Type: -

Identifier Source: org_study_id