- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04235530
Comparison of Ultrasonography Guided Serratus Anterior Plane Block and Thoracic Paravertebral Block in Thoracic Surgery
January 17, 2020 updated by: Merve Sena BAYTAR
Comparison of Ultrasonography Guided Serratus Anterior Plane Block and Thoracic Paravertebral Block in Video-Assisted Thoracoscopic Surgery: A Prospective Randomized Double-blind Study
The aim of this study is comparison of the effectiveness of ultrasound guided serratus anterior plane block and thoracic paravertebral block as a preventive analgesia method after VATS.
Our secondary aim is to investigate patient and surgeon satisfaction, duration of block application, postoperative complications and hospital lenght of stay.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
5
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 Yüksek İhtisas Education 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 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
who underwent elective video-assisted thoracoscopic surgery
Description
Inclusion Criteria:
- aged between 18 and 65 years
- ASA (American Society of Anesthesiologists) score I-II
Exclusion Criteria:
- inability to communicate
- body mass index (BMI) > 35 kg/m2
- infection in the area where the block was to be applied
- allergy to the drugs used
- mentally impaired
- bleeding impaired
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 |
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VAS and DVAS
To measure the pain score of patients after surgery
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pain scores in rest and coughing
Time Frame: 24 hours
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Pain scores observed after surgery at 0, 1 ,2 ,6 ,12 ,24 th hours by visual analog scale.
We assessed pain scores both in rest and coughing.
This scale scores pain from 0 to 10. 0 means no pain and 10 means unbearable pain.
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24 hours
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consumption of opioids
Time Frame: 24 hours
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We observed how much opioid ( how many miligrams) the patient consumed in 24 hours postoperatively with pca device.
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24 hours
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
postoperative complications
Time Frame: 24 hours
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we compare postoperative complications like nausea, vomiting, constipation, pruritus first 24 hours after surgery.
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24 hours
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lenght of hospital stay
Time Frame: 48 hours
|
we compared how many days the patients stayed in the hospital until discharge
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48 hours
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
April 15, 2018
Primary Completion (Actual)
October 15, 2018
Study Completion (Actual)
February 1, 2019
Study Registration Dates
First Submitted
January 13, 2020
First Submitted That Met QC Criteria
January 17, 2020
First Posted (Actual)
January 22, 2020
Study Record Updates
Last Update Posted (Actual)
January 22, 2020
Last Update Submitted That Met QC Criteria
January 17, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-7/27
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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.
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