Diaphragmatic ParalysisNCT06146179
Combined Anterior Suprascapular Nerve Block and Superficial Cervical Plexus Block In Shoulder Arthroplasty Surgery
An observational study of Diaphragmatic Paralysis and Anterior Suprascapular Nerve Block, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial summary
The suprascapular nerve, originating from the C5 trunk, provides innervation to the acromioclavicular and glenohumeral joints. The supraclavicular nerve, a branch of the cervical plexus, contributes to the sensory innervation of the upper deltoid region. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diaphragmatic Paralysis, Anterior Suprascapular Nerve Block, Superficial Cervical Plexus Block
- How many people
- 8 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2023to 30 May 2024
- 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: Participants who underwent combined anterior suprascapular nerve block and superficial cervical plexus block in reverse shoulder arthroplasty surgery
Who may be able to join
- Population is defined by database within a given time frame
- Participants who underwent combined anterior suprascapular nerve block and superficial cervical plexus block in reverse shoulder arthroplasty surgery
- Participants aged 18-80
- ASA I-II-III
Who cannot join
- ASA score > III
- Pediatric individuals under 18 years of age
- Individuals who are pregnant
- Known diaphragmatic paralysis
- Had an allergy or toxicity to local anesthetic agents
- Have an opioid drug allergy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Application Of Combined Anterior Suprascapular Nerve Block and Superficial Cervical Plexus Block In Reverse Shoulder Arthroplasty Surgery, A Case Series
The suprascapular nerve, originating from the C5 trunk, provides innervation to the acromioclavicular and glenohumeral joints. The supraclavicular nerve, a branch of the cervical plexus, contributes to the sensory innervation of the upper deltoid region. Cervical and brachial plexus blocks can cause diaphragm paralysis. This study examined the effects of low-volume combined anterior suprascapular nerve block and superficial cervical plexus block on pain and phrenic nerve in participants underwent reverse shoulder arthroplasty surgery.
Read the detailed description
A retrospective analysis was performed on data obtained from eight participants who underwent reverse shoulder arthroplasty surgery. Anterior suprascapular nerve block and superficial cervical plexus block were applied to these participants. Anterior suprascapular nerve block was performed using 5 ml and superficial cervical plexus block was performed using 3 ml of %0,5 bupivacaine. Ultrasound was used to measure the diaphragm thickness at the end of inspiration and expiration, and to calculate the diaphragm thickness fraction. Postoperative pain management included patient-controlled analgesia with morphine, opioid consumption and VAS score recorded by pain observation forms.
Data will be collected by examining these pain observation forms and diaphragm thickness measurements.
- Conditions
- Diaphragmatic Paralysis, Anterior Suprascapular Nerve Block, Superficial Cervical Plexus Block, Phrenic Nerve Paralysis
- Keywords
- diaphragmatic paralysis, anterior suprascapular nerve block, superficial cervical plexus block, reverse shoulder replacement, shoulder pain
- Medical subject headings
- Respiratory Paralysis, Shoulder Pain
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 |
|---|---|---|
| Group 1 | Group 1: Combined Anterior Suprascapular Nerve Block and Superficial Cervical Plexus Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Change Ratio of Diaphragm Thickness Fraction
Postoperative Change Ratio of Diaphragm Thickness Fraction (%) at Postoperatively 30th. min.
Measured: Postoperatively 30th. min.
Secondary outcomes (10)
Pain Assessment with Visual Analogue Scale at postoperatively 30th. Min.
Postoperative VAS score (Ranging from 0-10)
Measured: Postoperatively 30th. min
Pain Assessment with Visual Analogue Scale at postoperatively 4th. Hours.
Postoperative VAS score (Ranging from 0-10)
Measured: Postoperatively 4th. hour
Pain Assessment with Visual Analogue Scale at postoperatively 6th. Hours.
Postoperative VAS score (Ranging from 0-10)
Measured: Postoperatively 6th. hour
Pain Assessment with Visual Analogue Scale at postoperatively 12th. Hours.
Postoperative VAS score (Ranging from 0-10)
Measured: Postoperatively 12th. hour
Pain Assessment with Visual Analogue Scale at postoperatively 24th. Hours.
Postoperative VAS score (Ranging from 0-10)
Measured: Postoperatively 24th. hour
Opioid Consumption at postoperatively 30th. Min.
Postoperative Opioid Consumption with Morphine PCA (0.5 mg/cc, demand dose 2 cc, lock of time; 10 min. )
Measured: Postoperatively 30th. min.
Opioid Consumption at postoperatively 4th. Hours.
Postoperative Opioid Consumption with Morphine PCA (0.5 mg/cc, demand dose 2 cc, lock of time; 10 min. )
Measured: Postoperatively 4th. hour
Opioid Consumption at postoperatively 6th. Hours.
Postoperative Opioid Consumption with Morphine PCA (0.5 mg/cc, demand dose 2 cc, lock of time; 10 min. )
Measured: Postoperatively 6th. hour
Opioid Consumption at postoperatively 12th. Hours.
Postoperative Opioid Consumption with Morphine PCA (0.5 mg/cc, demand dose 2 cc, lock of time; 10 min. )
Measured: Postoperatively 12th. hour
Opioid Consumption at postoperatively 24th. Hours.
Postoperative Opioid Consumption with Morphine PCA (0.5 mg/cc, demand dose 2 cc, lock of time; 10 min. )
Measured: Postoperatively 24th. hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2023
- Study start1 Nov 2023
- Primary completion30 Mar 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diaphragmatic ParalysisStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebru Girgin Dinç, MD, Istanbul Medeniyet University
- Investigators
- Ebru Girgin Dinç, Study director, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06146179
- Sponsor's protocol ID
- 2023/0363
- Status last verified
- Dec 2024
- First submitted
- 17 Nov 2023
- Last updated
- 19 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application Of Combined Anterior Suprascapular Nerve Block and Superficial Cervical Plexus Block In Reverse Shoulder Arthroplasty Surgery, A Case Series
- ClinicalTrials.gov ID
- NCT06146179
- Acronym / sponsor ID
- 2023/0363
- Conditions
- Diaphragmatic Paralysis, Anterior Suprascapular Nerve Block, Superficial Cervical Plexus Block, Phrenic Nerve Paralysis
- Keywords
- diaphragmatic paralysis, anterior suprascapular nerve block, superficial cervical plexus block, reverse shoulder replacement, shoulder pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 24 Nov 2023 (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.
The suprascapular nerve, originating from the C5 trunk, provides innervation to the acromioclavicular and glenohumeral joints. The supraclavicular nerve, a branch of the cervical plexus, contributes to the sensory innervation of the upper deltoid region. Cervical and brachial plexus blocks can cause diaphragm paralysis. This study examined the effects of low-volume combined anterior suprascapular nerve block and superficial cervical plexus block on pain and phrenic nerve in participants underwent reverse shoulder arthroplasty surgery.
Detailed description
A retrospective analysis was performed on data obtained from eight participants who underwent reverse shoulder arthroplasty surgery. Anterior suprascapular nerve block and superficial cervical plexus block were applied to these participants. Anterior suprascapular nerve block was performed using 5 ml and superficial cervical plexus block was performed using 3 ml of %0,5 bupivacaine. Ultrasound was used to measure the diaphragm thickness at the end of inspiration and expiration, and to calculate the diaphragm thickness fraction. Postoperative pain management included patient-controlled analgesia with morphine, opioid consumption and VAS score recorded by pain observation forms.
Data will be collected by examining these pain observation forms and diaphragm thickness measurements.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Group 1: Combined Anterior Suprascapular Nerve Block and Superficial Cervical Plexus Block |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants who underwent combined anterior suprascapular nerve block and superficial cervical plexus block in reverse shoulder arthroplasty surgery
Key inclusion criteria (4 listed)
- Population is defined by database within a given time frame
- Participants who underwent combined anterior suprascapular nerve block and superficial cervical plexus block in reverse shoulder arthroplasty surgery
- Participants aged 18-80
- ASA I-II-III
Key exclusion criteria (6 listed)
- ASA score > III
- Pediatric individuals under 18 years of age
- Individuals who are pregnant
- Known diaphragmatic paralysis
- Had an allergy or toxicity to local anesthetic agents
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
Postoperative Change Ratio of Diaphragm Thickness Fraction
Time frame: Postoperatively 30th. min.
Postoperative Change Ratio of Diaphragm Thickness Fraction (%) at Postoperatively 30th. min.
10 secondary outcomes
Pain Assessment with Visual Analogue Scale at postoperatively 30th. Min.
Time frame: Postoperatively 30th. min
Pain Assessment with Visual Analogue Scale at postoperatively 4th. Hours.
Time frame: Postoperatively 4th. hour
Pain Assessment with Visual Analogue Scale at postoperatively 6th. Hours.
Time frame: Postoperatively 6th. hour
Pain Assessment with Visual Analogue Scale at postoperatively 12th. Hours.
Time frame: Postoperatively 12th. hour
Pain Assessment with Visual Analogue Scale at postoperatively 24th. Hours.
Time frame: Postoperatively 24th. hour
Opioid Consumption at postoperatively 30th. Min.
Time frame: Postoperatively 30th. min.
Opioid Consumption at postoperatively 4th. Hours.
Time frame: Postoperatively 4th. hour
Opioid Consumption at postoperatively 6th. Hours.
Time frame: Postoperatively 6th. hour
Opioid Consumption at postoperatively 12th. Hours.
Time frame: Postoperatively 12th. hour
Opioid Consumption at postoperatively 24th. Hours.
Time frame: Postoperatively 24th. hour
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 19 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Diaphragmatic Paralysis
Not yet recruiting
Impact of High Thoracic Paravertebral Block on Diaphragmatic Function: a Prospective Study
Breast Cancer Surgery, Breast Cancer Surgery Pain
Recruiting
Evaluation of Diaphragmatic Function After Interscalene Block With Liposomal Bupivacaine
Diaphragmatic Function, Metacarpal Fracture
Not yet recruitingPhase 4
Comparative Evaluation of Diaphragmatic Function Following Interscalene, Anterior Suprascapular, and Costoclavicular Nerve Blocks in Shoulder Surgery
Hemidiaphragmatic Paralysis, Postoperative Pain
Recruiting
Diaphragmatic Evaluation by Fluoroscopy to Identify Phrenic Nerve Dysfunction Related to Electroporation
Atrial Fibrillation
Enrolling by invitation
Transcutaneous Diaphragmatic Electrical Stimulation and Pulmonary Function in Non-Ambulatory Cerebral Palsy
Cerebral Palsy
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.
Ebru Girgin Dinç study director
Istanbul Medeniyet 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 Diaphragmatic Paralysis and Anterior Suprascapular Nerve Block, run by Istanbul Medeniyet 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 19 Dec 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?
Postoperative Change Ratio of Diaphragm Thickness Fraction (time frame: Postoperatively 30th. min.). 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 19 Dec 2024.