Anesthesia Methods on Percutaneous Kyphoplasty
August 31, 2022 updated by: Tugba Onur, Bursa Yüksek İhtisas Education and Research Hospital
Evaluation of Anesthesia Methods in Patients Undergoing Percutaneous Kyphoplasty: A Prospective Study
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
66
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Bursa, Turkey, 16600
- Bursa Training and Research Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 100 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
18-100 aged kyphoplasty patients
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Group 1
General anesthesia or sedation
|
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
|
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)
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative Visual Analog Scala (VAS) values
Time Frame: 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.
|
VAS values at postoperative 24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Analgesic consumption
Time Frame: 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.
|
postoperative 24 hours after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Anıl A Onur, MD, Bursa Medicabil Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 1, 2022
Primary Completion (ACTUAL)
July 1, 2022
Study Completion (ACTUAL)
August 1, 2022
Study Registration Dates
First Submitted
August 25, 2022
First Submitted That Met QC Criteria
August 31, 2022
First Posted (ACTUAL)
September 2, 2022
Study Record Updates
Last Update Posted (ACTUAL)
September 2, 2022
Last Update Submitted That Met QC Criteria
August 31, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-KAEK-25 2021/12-09
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
With the written consent of the patients and the approval of the ethics committee, I do not intend to share their special circumstances and information other than the study data.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.