- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05563025
Comparison of Time and Cost Efficiency in Arthroscopic Shoulder Surgery Under Regional Anesthesia vs General Anesthesia (vs)
December 16, 2022 updated by: Samsun University
Arthroscopic Shoulder surgery can be done not only under general anesthesia but also regional technics.
In this study we aimed to compare the cost and time effectiveness of regional anesthesia and general anesthesia.
Study Overview
Status
Recruiting
Conditions
Detailed Description
In our routine practice, ultrasound guided brachial plexus blocks or general anesthesia can be used during shoulder surgery.
This retrospective study is designed to investigate the data of the patients who underwent arthroscopic shoulder between 01.09.2021-01.09.2022 at Samsun University Education and Research Hospital.
As well as patients' demographic data, presence of additional diseases, operation indications, duration of surgery, intraoperative medical agents that are used, duration of hospital stay will be collected from patients files.Fees for materials used for general anesthesia and regional anesthesia will be determined.
A fixed cost will be determined for the use of the operating room, including the salaries of the healthcare workers.
After final calculation of both of the group costs statistical analysis will be made.
Study Type
Observational
Enrollment (Anticipated)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Murat Ünal
- Phone Number: 1128 +90 362 311 1500
- Email: murat.unal@yahoo.com
Study Locations
-
-
-
Samsun, Turkey
- Recruiting
- Samsun University
-
Contact:
- Murat Unal
- Phone Number: 1128 +903623111500
- Email: murat.unal@yahoo.com
-
-
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
14 years to 76 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All patients between age 18 and 80 of ASA status 1,2,3 who underwent Arthroscopic Shoulder Surgery under General or Regional Anesthesia between 01.09.2021 and 01.09.2022.
Description
Inclusion Criteria:
- American Society of Anesthesiology (ASA) 1-2-3
- Arthroscopic Shoulder Surgery
Exclusion Criteria:
- Emergency surgery
- ASA -4
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
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
|---|
|
General
Arthroscopic Shoulder Surgery under General Anesthesia
|
|
Regional
Arthroscopic Shoulder Surgery under Regional Anesthesia
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cost of Regional Anesthesia and General Anesthesia
Time Frame: 1 year
|
Calculation of peroperative costs of patients undergoing arthroscopic shoulder surgery under general or regional anesthesia.
excluding surgical materials
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time
Time Frame: 1 year
|
Measuring the operation room usage under general or regional anesthesia
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Serkan Tulgar, Samsun University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Gonano C, Kettner SC, Ernstbrunner M, Schebesta K, Chiari A, Marhofer P. Comparison of economical aspects of interscalene brachial plexus blockade and general anaesthesia for arthroscopic shoulder surgery. Br J Anaesth. 2009 Sep;103(3):428-33. doi: 10.1093/bja/aep173. Epub 2009 Jul 8.
- Hewson DW, Oldman M, Bedforth NM. Regional anaesthesia for shoulder surgery. BJA Educ. 2019 Apr;19(4):98-104. doi: 10.1016/j.bjae.2018.12.004. Epub 2019 Feb 6. No abstract available.
- Tapar H, Suren M, Kaya Z, Arıcı S, Karaman S, Kahveci M. Üst Ekstremite Periferik Blok Anestezisi Ve Komplikasyonları. Journal of Contemporary Medicine 2012;2(3):195-200.
- Komann M, Avian A, Dreiling J, Gerbershagen H, Volk T, Weinmann C, Meissner W. Association of Perioperative Regional Analgesia with Postoperative Patient-Reported Pain Outcomes and Opioid Requirements: Comparing 22 Different Surgical Groups in 23,911 Patients from the QUIPS Registry. J Clin Med. 2021 May 19;10(10):2194. doi: 10.3390/jcm10102194.
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)
December 16, 2022
Primary Completion (Anticipated)
January 1, 2023
Study Completion (Anticipated)
January 1, 2023
Study Registration Dates
First Submitted
September 28, 2022
First Submitted That Met QC Criteria
September 28, 2022
First Posted (Actual)
October 3, 2022
Study Record Updates
Last Update Posted (Actual)
December 19, 2022
Last Update Submitted That Met QC Criteria
December 16, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- SamsunU_Art_Should_cost
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
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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