Shoulder ArthroplastyNCT04822610
Comparison of Interscalene Block and Suprascapular With Axillary Block
A study testing interscalene block and suprascapular block + axillary block in people with Shoulder Arthroplasty and Ultrasound Guided, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
In this study, the investigators are going to compare the analgesia effectiveness of interscalane block and suprascapular with axillary block in shoulder arthroplasties Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Shoulder Arthroplasty, Ultrasound Guided
- What is being tested?
- interscalene block and suprascapular block + axillary block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jun 2021to 31 Jan 2022
- Phase
- Interventional
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- accepting the study protocol,
- age older than 18 years and younger than 90 years,
- undergoing shoulder arthroplasty surgery
- the American Society of Anesthesiologist (ASA) physical status of I-II-III-IV
Who cannot join
- severe respiratory distress
- patients with local anesthetic allergy
- contralateral hemidiaphragmatic parrhesia
- recurrent laryngeal nerve palsy
- infection at the injection site
- coagulation disorder
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University, Faculty of Medicine
Istanbul, Fatih, 34093
About this study
Official title: Comparison of Analgesic Effectiveness of Ultrasound Guided Interscalene Block Versus Suprascapular With Axillary Block in Shoulder Arthroplasties
In this study, the investigators are going to compare the analgesia effectiveness of interscalane block and suprascapular with axillary block in shoulder arthroplasties
Read the detailed description
In the preoperative period, the participants will be taken to the block room. The participants will be monitored, standard sedation will be applied.
The first group will be get interscalene block. The second group will be get suprascapular and axillary block. The third group patient will be get no block. Afterwards, the participants will be operated under general anesthesia. A patient-controlled analgesia device will be attached to each group of participants and their postoperative follow-up will be made.
- Conditions
- Shoulder Arthroplasty, Ultrasound Guided
- Being tested
- interscalene block, suprascapular block + axillary block
- Keywords
- axillary block, suprascapular block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interscalene blockProcedure or surgery
peripheral nerve block
suprascapular block + axillary blockProcedure or surgery
peripheral nerve block
| Study group | Role | What they receive |
|---|---|---|
| Study group: interscalene block + IV PCA | Experimental | preop usg guided interscalene block and IV PCA Receives: Procedure: interscalene block |
| Study group: suprascapular block + axillary block + IV PCA | Experimental | preop usg guided suprascapular block + axillary block and IV PCA Receives: Procedure: suprascapular block + axillary block |
| Control group: IV PCA | No intervention | no block + IV PCA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid (mg) consumption
Opioid (mg) consumption
Measured: 48 hours
Measurement of postoperative pain
VAS (visual analog scale) (0: no pain, 10: the worst pain imaginable)
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2021
- Study start30 Jun 2021
- Primary completion21 Jan 2022
- Study completion31 Jan 2022
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 Shoulder ArthroplastyStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study group - Study group- Control group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nur Canbolat, Istanbul University
- Investigators
- Kübra Ozkan, MD, Principal investigator, Istanbul Unıversity, Istanbul Faculty of Medicine, Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04822610
- Sponsor's protocol ID
- 2020/1562
- Status last verified
- Jan 2022
- First submitted
- 19 Jan 2021
- Last updated
- 1 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Toma O, Persoons B, Pogatzki-Zahn E, Van de Velde M, Joshi GP; PROSPECT Working Group collaborators. PROSPECT guideline for rotator cuff repair surgery: systematic review and procedure-specific postoperative pain management recommendations. Anaesthesia. 2019 Oct;74(10):1320-1331. doi: 10.1111/anae.14796. Epub 2019 Aug 7.
PubMed 31392721Lee SM, Park SE, Nam YS, Han SH, Lee KJ, Kwon MJ, Ji JH, Choi SK, Park JS. Analgesic effectiveness of nerve block in shoulder arthroscopy: comparison between interscalene, suprascapular and axillary nerve blocks. Knee Surg Sports Traumatol Arthrosc. 2012 Dec;20(12):2573-8. doi: 10.1007/s00167-012-1950-5. Epub 2012 Mar 21.
PubMed 22434159Park JY, Bang JY, Oh KS. Blind suprascapular and axillary nerve block for post-operative pain in arthroscopic rotator cuff surgery. Knee Surg Sports Traumatol Arthrosc. 2016 Dec;24(12):3877-3883. doi: 10.1007/s00167-015-3902-3. Epub 2016 Jan 5.
PubMed 26733274Cho N, Kang RS, McCartney CJL, Pawa A, Costache I, Rose P, Abdallah FW. Analgesic benefits and clinical role of the posterior suprascapular nerve block in shoulder surgery: a systematic review, meta-analysis and trial sequential analysis. Anaesthesia. 2020 Mar;75(3):386-394. doi: 10.1111/anae.14858. Epub 2019 Oct 3.
PubMed 31583679
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Analgesic Effectiveness of Ultrasound Guided Interscalene Block Versus Suprascapular With Axillary Block in Shoulder Arthroplasties
- ClinicalTrials.gov ID
- NCT04822610
- Acronym / sponsor ID
- 2020/1562
- Conditions
- Shoulder Arthroplasty, Ultrasound Guided
- Keywords
- axillary block, suprascapular block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 30 Jun 2021 (actual)
- Primary completion
- 21 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 30 Mar 2021 (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.
In this study, the investigators are going to compare the analgesia effectiveness of interscalane block and suprascapular with axillary block in shoulder arthroplasties
Detailed description
In the preoperative period, the participants will be taken to the block room. The participants will be monitored, standard sedation will be applied.
The first group will be get interscalene block. The second group will be get suprascapular and axillary block. The third group patient will be get no block. Afterwards, the participants will be operated under general anesthesia. A patient-controlled analgesia device will be attached to each group of participants and their postoperative follow-up will be made.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Study group - Study group- Control group
| Arm | Type | Receives |
|---|---|---|
| Study group: interscalene block + IV PCA | Experimental | Procedure: interscalene blockpreop usg guided interscalene block and IV PCA |
| Study group: suprascapular block + axillary block + IV PCA | Experimental | Procedure: suprascapular block + axillary blockpreop usg guided suprascapular block + axillary block and IV PCA |
| Control group: IV PCA | No intervention | –no block + IV PCA |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- accepting the study protocol,
- age older than 18 years and younger than 90 years,
- undergoing shoulder arthroplasty surgery
- the American Society of Anesthesiologist (ASA) physical status of I-II-III-IV
Key exclusion criteria (6 listed)
- severe respiratory distress
- patients with local anesthetic allergy
- contralateral hemidiaphragmatic parrhesia
- recurrent laryngeal nerve palsy
- infection at the injection site
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 |
|---|---|---|
| interscalene blockperipheral nerve block | Procedure or surgery | Study group: interscalene block + IV PCA |
| suprascapular block + axillary blockperipheral nerve block | Procedure or surgery | Study group: suprascapular block + axillary block + IV PCA |
Primary outcome
Opioid (mg) consumption
Time frame: 48 hours
Opioid (mg) consumption
Measurement of postoperative pain
Time frame: 48 hours
VAS (visual analog scale) (0: no pain, 10: the worst pain imaginable)
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 1 Feb 2022.
- Background: PubMed 31392721Toma O, Persoons B, Pogatzki-Zahn E, Van de Velde M, Joshi GP; PROSPECT Working Group collaborators. PROSPECT guideline for rotator cuff repair surgery: systematic review and procedure-specific postoperative pain management recommendations. Anaesthesia. 2019 Oct;74(10):1320-1331. doi: 10.1111/anae.14796. Epub 2019 Aug 7.
- Background: PubMed 22434159Lee SM, Park SE, Nam YS, Han SH, Lee KJ, Kwon MJ, Ji JH, Choi SK, Park JS. Analgesic effectiveness of nerve block in shoulder arthroscopy: comparison between interscalene, suprascapular and axillary nerve blocks. Knee Surg Sports Traumatol Arthrosc. 2012 Dec;20(12):2573-8. doi: 10.1007/s00167-012-1950-5. Epub 2012 Mar 21.
- Background: PubMed 26733274Park JY, Bang JY, Oh KS. Blind suprascapular and axillary nerve block for post-operative pain in arthroscopic rotator cuff surgery. Knee Surg Sports Traumatol Arthrosc. 2016 Dec;24(12):3877-3883. doi: 10.1007/s00167-015-3902-3. Epub 2016 Jan 5.
- Background: PubMed 31583679Cho N, Kang RS, McCartney CJL, Pawa A, Costache I, Rose P, Abdallah FW. Analgesic benefits and clinical role of the posterior suprascapular nerve block in shoulder surgery: a systematic review, meta-analysis and trial sequential analysis. Anaesthesia. 2020 Mar;75(3):386-394. doi: 10.1111/anae.14858. Epub 2019 Oct 3.
- Individual participant dataSharing planned: No
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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.
Kübra Ozkan, MD principal investigator
Istanbul Unıversity, Istanbul Faculty of Medicine, Anesthesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing interscalene block and suprascapular block + axillary block in people with Shoulder Arthroplasty and Ultrasound Guided, run by Istanbul 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 4 inclusion and 6 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 1 Feb 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?
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?
Opioid (mg) consumption (time frame: 48 hours). 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?
On the ClinicalTrials.gov record for NCT04822610, 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 1 Feb 2022.