AnesthesiavsNCT05563025
Comparison of Time and Cost Efficiency in Arthroscopic Shoulder Surgery Under Regional Anesthesia vs General Anesthesia
An observational study of Anesthesia, run by Samsun University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Anesthesia
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Dec 2022to 1 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- American Society of Anesthesiology (ASA) 1-2-3
- Arthroscopic Shoulder Surgery
Who cannot join
- Emergency surgery
- ASA -4
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Samsun University
Samsun
Murat Unal, +903623111500 ext. 1128, murat.unal@yahoo.com
About this study
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.
Read the 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.
- Conditions
- Anesthesia
- Keywords
- Cost, Regional Anesthesia, Shoulder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| General | Arthroscopic Shoulder Surgery under General Anesthesia | |
| Regional | Arthroscopic Shoulder Surgery under Regional Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost of Regional Anesthesia and General Anesthesia
Calculation of peroperative costs of patients undergoing arthroscopic shoulder surgery under general or regional anesthesia. excluding surgical materials
Measured: 1 year
Secondary outcomes (1)
Time
Measuring the operation room usage under general or regional anesthesia
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2022
- Study start16 Dec 2022
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsun University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Serkan Tulgar, Study chair, Samsun University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05563025
- Sponsor's protocol ID
- SamsunU_Art_Should_cost
- Acronym
- vs
- Status last verified
- Dec 2022
- First submitted
- 28 Sep 2022
- Last updated
- 19 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
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.
PubMed 33456877Komann 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.
PubMed 34069496Gonano 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.
PubMed 19586958
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Time and Cost Efficiency in Arthroscopic Shoulder Surgery Under Regional Anesthesia vs General Anesthesia
- ClinicalTrials.gov ID
- NCT05563025
- Acronym / sponsor ID
- vs / SamsunU_Art_Should_cost
- Conditions
- Anesthesia
- Keywords
- Cost, Regional Anesthesia, Shoulder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Samsun UniversityUniversity, hospital or other
- Study start
- 16 Dec 2022 (actual)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 3 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General | – | –Arthroscopic Shoulder Surgery under General Anesthesia |
| Regional | – | –Arthroscopic Shoulder Surgery under Regional Anesthesia |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- American Society of Anesthesiology (ASA) 1-2-3
- Arthroscopic Shoulder Surgery
Key exclusion criteria (2 listed)
- Emergency surgery
- ASA -4
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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 secondary outcome
Time
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2022.
- BackgroundTapar 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.
- Background: PubMed 33456877Hewson 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.
- Background: PubMed 34069496Komann 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.
- Background: PubMed 19586958Gonano 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Serkan Tulgar study chair
Samsun University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, run by Samsun University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Murat Ünal (+90 362 311 1500 ext. 1128, murat.unal@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cost of Regional Anesthesia and General Anesthesia (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05563025, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2022.