Pain, PostoperativeNCT06265571
Postoperative Pain in Shoulder Surgery
An observational study of Pain, Postoperative, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
Trial summary
After the approval of the ethics committee, the files of the patients who underwent arthroscopic shoulder surgery between 01.01.2019 and 01.03.2020 were evaluated retrospectively. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- perineural injection
- Type of treatment
- Injection or infusion
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2020to 15 Jul 2021
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: >18 years old patients undergoing arthroscopic shoulder surgery by the same surgeon.
Who may be able to join
- arthroscopic shoulder surgery full data form
Who cannot join
- chronic obstructive lung disease chronic opoid consumption missing data from the postoperative pain form
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Ultrasound-Guided Suprascapular Block Plus Low-dose Interscalen Brachial Plexus Block for Postoperative Pain in Shoulder Surgery
After the approval of the ethics committee, the files of the patients who underwent arthroscopic shoulder surgery between 01.01.2019 and 01.03.2020 were evaluated retrospectively.
Data were recorded including age, gender, duration of anesthesia, duration of surgery, postoperative analgesia consumption, complications such as respiratory distress due to hemidiaphragmatic paralysis and complications such as hematoma and nerve damage due to block intervention.
Read the detailed description
Patients who underwent arthroscopic shoulder surgery and underwent USG-guided interscalene block and concomitant suprascapular block were included in the study. We tried to determine whether there is a difference between different dose regimens in order to determine the effective analgesic dose and minimize the side effects of dose-dependent interscalene block applications.
- Conditions
- Pain, Postoperative
- Being tested
- perineural injection
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
perineural injectionOther
perineural injection of local anesthestetic for postoperative pain management
| Study group | Role | What they receive |
|---|---|---|
| GROUP I | Interscalene block (group I)15 ml of 0.5% bupivacaine was applied with a single injection to 12 of 18 patients, Receives: Other: perineural injection | |
| GROUP II | 7.5 ml of interscalene and 7.5 ml of suprascapular block (GROUP II) were applied to 6 patients with posterior approach. Receives: Other: perineural injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
rescue analgesia
postoperative pain score (VAS) > 4 required to rescue analgesia
Measured: between 01.01.2019 and 01.03.2020
difference between the analgesic methods
Measured: between 01.01.2019 and 01.03.2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start15 Nov 2020
- Primary completion15 Jun 2021
- Study completion15 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ferda YAMAN, Eskisehir Osmangazi University
- Investigators
- Ferda YAMAN, Assoc prof, Study director, University of Eskişehir Osmangazi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06265571
- Sponsor's protocol ID
- EskisehirUO
- Status last verified
- Feb 2024
- First submitted
- 11 Sep 2023
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: reterospectively completed
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ultrasound-Guided Suprascapular Block Plus Low-dose Interscalen Brachial Plexus Block for Postoperative Pain in Shoulder Surgery
- ClinicalTrials.gov ID
- NCT06265571
- Acronym / sponsor ID
- EskisehirUO
- Conditions
- Pain, Postoperative
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- 15 Nov 2020 (actual)
- Primary completion
- 15 Jun 2021 (actual)
- Study completion
- 15 Jul 2021 (actual)
- First posted
- 20 Feb 2024 (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.
After the approval of the ethics committee, the files of the patients who underwent arthroscopic shoulder surgery between 01.01.2019 and 01.03.2020 were evaluated retrospectively.
Data were recorded including age, gender, duration of anesthesia, duration of surgery, postoperative analgesia consumption, complications such as respiratory distress due to hemidiaphragmatic paralysis and complications such as hematoma and nerve damage due to block intervention.
Detailed description
Patients who underwent arthroscopic shoulder surgery and underwent USG-guided interscalene block and concomitant suprascapular block were included in the study. We tried to determine whether there is a difference between different dose regimens in order to determine the effective analgesic dose and minimize the side effects of dose-dependent interscalene block applications.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GROUP I | – | Other: perineural injectionInterscalene block (group I)15 ml of 0.5% bupivacaine was applied with a single injection to 12 of 18 patients, |
| GROUP II | – | Other: perineural injection7.5 ml of interscalene and 7.5 ml of suprascapular block (GROUP II) were applied to 6 patients with posterior approach. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- >18 years old patients undergoing arthroscopic shoulder surgery by the same surgeon.
Key inclusion criteria (1 listed)
- arthroscopic shoulder surgery full data form
Key exclusion criteria (1 listed)
- chronic obstructive lung disease chronic opoid consumption missing data from the postoperative pain form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| perineural injectionperineural injection of local anesthestetic for postoperative pain management | Other | GROUP I, GROUP II |
Primary outcome
rescue analgesia
Time frame: between 01.01.2019 and 01.03.2020
postoperative pain score (VAS) > 4 required to rescue analgesia
difference between the analgesic methods
Time frame: between 01.01.2019 and 01.03.2020
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Individual participant dataSharing planned: Undecided. reterospectively completed
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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.
Ferda YAMAN, Assoc prof study director
University of Eskişehir Osmangazi
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 Pain, Postoperative, run by Eskisehir Osmangazi 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 20 Feb 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rescue analgesia (time frame: between 01.01.2019 and 01.03.2020). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Feb 2024.