Anesthesia Methods on Percutaneous Kyphoplasty

NCT05526794 | Completed

• 1 other identifier: 2021-KAEK-25 2021/12-09
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

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).

Conditions

Vertebral Fracture

Keywords

percutan kyphoplasty; Vertebroplasty

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Analgesic consumption

  postoperative 24 hours after surgery

Study Arms (3)

Group 1

General anesthesia or sedation

Procedure: Analgesic consumption

Group 2

Central Block (Spinal and Epidural Anesthesia

Procedure: Analgesic consumption

Group 3

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

Procedure: Analgesic consumption

Interventions

Analgesic consumption 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 1; Group 2; Group 3

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

18-100 aged kyphoplasty patients

You may qualify if:

• ages kyphoplasty surgery patients
• written consent form received

You may not qualify if:

• 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

Sponsors & Collaborators

• Bursa Yuksek Ihtisas Training and Research Hospital: lead

Study Sites (1)

Bursa Training and Research Hospital

Bursa, 16600, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Spinal Fractures

Condition Hierarchy (Ancestors)

Spinal Injuries; Back Injuries; Wounds and Injuries; Fractures, Bone

Study Officials

• Tuğba T Onur, MD

  Bursa Yuksek Ihtisas Training and Research Hospital

  PRINCIPAL INVESTIGATOR

• Ümran Ü Karaca, MD

  Bursa Yuksek Ihtisas Training and Research Hospital

  STUDY CHAIR

• Asiye A Demirel, MD

  Bursa Yuksek Ihtisas Training and Research Hospital

  STUDY CHAIR

• Şeyda Efsun ŞE Özgünay, Assoc Prof

  Bursa Yuksek Ihtisas Training and Research Hospital

  STUDY CHAIR

• Anıl A Onur, MD

  Bursa Medicabil Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal İnvestigator

Study Record Dates

• First Submitted: August 25, 2022
• First Posted: September 2, 2022
• Study Start: January 1, 2022
• Primary Completion: July 1, 2022
• Study Completion: August 1, 2022
• Last Updated: September 2, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)