Arthroscopic Shoulder SurgeryPMSSNCT04101266
Pain Management in Arthtroscopic Shoulder Surgery
A study testing Interscalene block and suprascapular and infraclavicular nerve block in people with Arthroscopic Shoulder Surgery, run by Diskapi Yildirim Beyazit Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
It is compared that combined suprascapular and infraclavicular nerve blocks to interscalene nerve block for clinical outcomes after shoulder surgery Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Arthroscopic Shoulder Surgery
- What is being tested?
- Interscalene block and suprascapular and infraclavicular nerve block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Sep 2019to 1 Apr 2020
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for elective shoulder surgery under general anesthesia with suprascapular + infraclavicular nerve block or interscalene nerve block for any reason ASA 1-3 patients
Who cannot join
- Diabetes
- coagulopathy
- local anesthetic allergy
- chronic opioid users
- neurological deficit of the surgical limb
- obstructive or restrictive pulmoner disease
- inability to understand pain scores
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Diskapi Yildiim Beyazit Eduation and Research Hospital
Ankara
About this study
Official title: Comparison of the Effects Combined Suprascapular and Infraclavicular Nerve Blocks to Interscalene Nerve Block Applied Arthtroscopic Shoulder Surgery
It is compared that combined suprascapular and infraclavicular nerve blocks to interscalene nerve block for clinical outcomes after shoulder surgery
Read the detailed description
In this study, the investigators planned to investigate postoperative pain, analgesic dosage, respiratory effects of the block and side effects of patients undergoing general anaesthesia after arthroscopic shoulder surgery under preoperative interscalene nerve block or suprascapular + infraclavicular nerve block.
- Conditions
- Arthroscopic Shoulder Surgery
- Being tested
- Interscalene block, suprascapular and infraclavicular nerve block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interscalene blockOther
30 minutes before anaesthesia induction interscalene nerve block will be applied with ultrasound guidance with %0,25 bupivacain 20 cc .The sham block consisted of after patients were placed in the lateral decubitus position skin preparation, ultrasound scanning of the suprascapular region, and a dry-needling, all performed to preserve patient blinding in the ISB group patients.
suprascapular and infraclavicular nerve blockOther
30 minutes before anaesthesia induction suprascapular with %0,25 bupivacain 10 cc .and infraclavicular nerve block with %0,25 bupivacain 10 cc will be applied with ultrasound guidance
| Study group | Role | What they receive |
|---|---|---|
| Interscalene nerve block | Active comparator | preoperative interscalene nerve block to be applied with ultrasound guidance. Receives: Other: Interscalene block |
| suprascapular and infraclavicular nerve block | Active comparator | preoperative suprascapular and infraclavicular nerve block to be with ultrasound guidance Receives: Other: suprascapular and infraclavicular nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain: numeric rating scale (NRS)
postoperative pain will be evaluated by numeric rating scale (NRS) .
Measured: postoperative 30. minute, 4. hour, 8.hour,12. hour, 24. hour, 48. hour
Secondary outcomes (1)
phrenic nerve paralysis evaluated with ultrasound
Thirty minutes after the block, M-mode ultrasound examination of the ipsilateral hemidiaphragm was performed to measure diaphragmatic excursion.
Measured: thirty minutes after the nerve block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2019
- Study start30 Sep 2019
- Primary completion1 Mar 2020
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroscopic Shoulder SurgeryStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Tugba Arslan, Diskapi Yildirim Beyazit Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04101266
- Sponsor's protocol ID
- 59/13
- Acronym
- PMSS
- Status last verified
- Jun 2021
- First submitted
- 17 Sep 2019
- Last updated
- 10 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects Combined Suprascapular and Infraclavicular Nerve Blocks to Interscalene Nerve Block Applied Arthtroscopic Shoulder Surgery
- ClinicalTrials.gov ID
- NCT04101266
- Acronym / sponsor ID
- PMSS / 59/13
- Conditions
- Arthroscopic Shoulder Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research HospitalOther government
- Study start
- 30 Sep 2019 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 24 Sep 2019 (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.
It is compared that combined suprascapular and infraclavicular nerve blocks to interscalene nerve block for clinical outcomes after shoulder surgery
Detailed description
In this study, the investigators planned to investigate postoperative pain, analgesic dosage, respiratory effects of the block and side effects of patients undergoing general anaesthesia after arthroscopic shoulder surgery under preoperative interscalene nerve block or suprascapular + infraclavicular nerve block.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interscalene nerve block | Active comparator | Other: Interscalene blockpreoperative interscalene nerve block to be applied with ultrasound guidance. |
| suprascapular and infraclavicular nerve block | Active comparator | Other: suprascapular and infraclavicular nerve blockpreoperative suprascapular and infraclavicular nerve block to be with ultrasound guidance |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled for elective shoulder surgery under general anesthesia with suprascapular + infraclavicular nerve block or interscalene nerve block for any reason ASA 1-3 patients
Key exclusion criteria (7 listed)
- Diabetes
- coagulopathy
- local anesthetic allergy
- chronic opioid users
- neurological deficit of the surgical limb
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 block30 minutes before anaesthesia induction interscalene nerve block will be applied with ultrasound guidance with %0,25 bupivacain 20 cc .The sham block consisted of after patients were placed in the lateral decubitus position skin preparation, ultrasound scanning of the suprascapular region, and a dry-needling, all performed to preserve patient blinding in the ISB group patients. | Other | Interscalene nerve block |
| suprascapular and infraclavicular nerve block30 minutes before anaesthesia induction suprascapular with %0,25 bupivacain 10 cc .and infraclavicular nerve block with %0,25 bupivacain 10 cc will be applied with ultrasound guidance | Other | suprascapular and infraclavicular nerve block |
Primary outcome
postoperative pain: numeric rating scale (NRS)
Time frame: postoperative 30. minute, 4. hour, 8.hour,12. hour, 24. hour, 48. hour
postoperative pain will be evaluated by numeric rating scale (NRS) .
1 secondary outcome
phrenic nerve paralysis evaluated with ultrasound
Time frame: thirty minutes after the nerve block
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 10 Jun 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 and infraclavicular nerve block in people with Arthroscopic Shoulder Surgery, run by Diskapi Yildirim Beyazit Education and Research Hospital 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 7 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 10 Jun 2021. 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?
postoperative pain: numeric rating scale (NRS) (time frame: postoperative 30. minute, 4. hour, 8.hour,12. hour, 24. hour, 48. hour). 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 10 Jun 2021.