Diaphragm Paralysis Due to Local AnesthesiaPhase 4NCT04626869
Anterior Suprascapular Nerve Block is an Effective and Diaphragm Protective Approach for Arthroscopic Shoulder Surgery
A Phase 4 study testing Evaluation of Diaphragm Movement in people with Diaphragm Paralysis Due to Local Anesthesia and Anterior Suprascapular Nerve Block, run by Alper Tunga Dogan at 1 site in Turkey (Türkiye).
Trial summary
Interscalene block is still the gold standard in shoulder surgery analgesia. The most important side effect is diaphragm paralysis due to the phrenic nerve being affected. It may cause symptomatic dyspnea, especially in patients with limited respiratory capacity. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Diaphragm Paralysis Due to Local Anesthesia, Anterior Suprascapular Nerve Block, Analgesia, Arthroscopic Shoulder Surgery
- What is being tested?
- Evaluation of Diaphragm Movement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2020to 1 Apr 2021
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients > 18 years old
- American Society of Anesthesiology (ASA) score of 1-3
- Scheduled for elective surgery.
Who cannot join
- Patients with a condition that prevents peripheral nerve block
- Coagulopathies
- Chronic opioid use
- Stroke
- Polyneuropathy
- Cognitive dysfunction
- Communication difficulties
- Allergies to drugs used
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anterior Suprascapular Nerve Block is as Effective as Interscalene Nerve Block and Causes Less Diapragm Paralysis in Arthroscopic Shoulder Surgery
Interscalene block is still the gold standard in shoulder surgery analgesia. The most important side effect is diaphragm paralysis due to the phrenic nerve being affected. It may cause symptomatic dyspnea, especially in patients with limited respiratory capacity. There are studies showing that an effective analgesia, as much as the interscalene block can do, can be provided by blocking the suprascapular nerve in the neck region.
The aim of our study is to show that the anterior suprascapular block applied with ultra-low volume (5ml) in shoulder arthroscopy operations is at least as effective as the interscalene block and does not cause diaphragm paralysis.
Read the detailed description
Interscalene block is still the gold standard in shoulder surgery analgesia. The most important side effect is diaphragm paralysis due to the phrenic nerve being affected. It may cause symptomatic dyspnea, especially in patients with limited respiratory capacity. More distal brachial plexus blocks have been defined to avoid diaphragmatic paralysis . Thus, it is aimed to apply the local anesthetic drug further from the phrenic nerve. With the application of ultrasound, the amount of local anesthetic drug was reduced to less than 20 ml.
There are studies showing that an effective analgesia, as much as the interscalene block can do, can be provided by blocking the suprascapular nerve in the neck region. Although it has been shown in a cadaver study that the phrenic nerve can be stained after anterior suprascapular nerve block, the clinical effect is not fully known.
The effect of continuous local anesthetic drug administration on respiratory muscles through catheters placed in the peripheral nerve is another matter of concern. The method that will not affect the phrenic nerve at all and at the same time provide an effective analgesia is still under investigation.
The aim of our study is to show that the anterior suprascapular block applied with ultra-low volume (5ml) in shoulder arthroscopy operations is at least as effective as the interscalene block and does not cause diaphragm paralysis. One of the questions that our research aims to answer is how the continuous application of local anesthetic drugs affects the diaphragm muscle with the insertion of catheters in both regions.
- Conditions
- Diaphragm Paralysis Due to Local Anesthesia, Anterior Suprascapular Nerve Block, Analgesia, Arthroscopic Shoulder Surgery
- Being tested
- Evaluation of Diaphragm Movement
- Keywords
- arthroscopic shoulder surgery, Interscalene nerve block, Anterior suprascapular nerve block, Analgesia, postoperative, Diaphragm paralysis
- Medical subject headings
- Agnosia, Respiratory Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of Diaphragm MovementOther
Diaphragmatic movement will be evaluated with ultrasonography and a 5-2 MHz convex transducer will be used. The ultrasound probe is placed between the mid-clavicular line and the anterior axillary line by directing it vertically and slightly cranially. During quiet breathing and deep breathing, diaphragm movement will be measured. The reduction in diaphragm motion will be calculated as the difference (in percent) in diaphragm motion measured before and 30 minutes after the block. Each test will be done 3 times and the values will be averaged. A decrease between 75% and 100% will be defined as complete paresis, a decrease between 25% and 75% as partial paresis, and less than 25% decrease in diaphragmatic movement will be defined as no paresis. In order to investigate the effect of continuous local anesthetic drug administration on diaphragm movement via nerve catheter, the same procedure will be repeated 24 hours after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Interscalene block | Active comparator | patients will be placed in a semi-sitting position with their heads facing the opposite side. Linear ultrasound probe (GE Loqic P9 7-15 MHz) to detect the brachial plexus. At the cervical level 5-6, the posterior brachial plexus will be approached as "in-plane" from the posterior with the needle (Contiplex C, Braun) through the catheter. The nerve structure will be confirmed with stimulation in the upper extremity muscles with a nerve stimulator and 5 ml 0.5% Bupivacaine will be injected. Receives: Other: Evaluation of Diaphragm Movement |
| Anterior suprascapular nerve block | Active comparator | patients will be placed in a semi-sitting position with their heads facing the opposite side. Linear ultrasound probe (GE Loqic P9 7-15 MHz) will be placed in the suprascapular region in a coronal oblique manner. The omohyoid muscle, under it the suprascapular nerve, the brachial plexus and the subclavian artery will be identified. The suprascapular nerve will be approached from the posterior as "in-plane" with a needle (Contiplex C, Braun) through the catheter. The nerve structure will be confirmed by stimulation in the supraspinous muscle with a nerve stimulator and 5 ml 0.5% Bupivacaine will be injected. Receives: Other: Evaluation of Diaphragm Movement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain rating
Measured by VAS. Postoperative 30 minutes
Measured: the first postoperative 30 minutes
Pain rating
Measured by VAS. Postoperative 6 hours
Measured: Postoperative 6 hours
Pain rating
Measured by VAS. Postoperative 12 hours
Measured: Postoperative 12 hours
Secondary outcomes (2)
Diaphragmatic movements
Diaphragmatic movement will be evaluated with ultrasound. 30 minutes after the block application.
Measured: 30 minutes after the block application.
Diaphragmatic movements
Diaphragmatic movement will be evaluated with ultrasound. 24 hours after the block application.
Measured: At the first postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2020
- Study start1 Dec 2020
- Primary completion15 Mar 2021
- Study completion1 Apr 2021
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 Diaphragm Paralysis Due to Local 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The patients will be divided into two groups as patients who underwent suprascapular nerve block with the supraclavicular approach and patients who underwent conventional interscalene nerve block. 5 ml of 0.5% Bupivacaine will be injected into both groups. Diaphragmatic movement will be evaluated with ultrasound at the right and left subcostal border with the patients in a semi-sitting position. The reduction in diaphragm motion will be calculated as the difference (in percent) in diaphragm motion measured before and 30 minutes after the block.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alper Tunga Dogan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alper Tunga Dogan, V.K.V. American Hospital, Istanbul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04626869
- Sponsor's protocol ID
- 2020.1234
- Status last verified
- Nov 2021
- First submitted
- 16 Sep 2020
- Last updated
- 30 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tran DQ, Layera S, Bravo D, Cristi-Sanchez I, Bermudez L, Aliste J. Diaphragm-sparing nerve blocks for shoulder surgery, revisited. Reg Anesth Pain Med. 2019 Sep 20:rapm-2019-100908. doi: 10.1136/rapm-2019-100908. Online ahead of print.
PubMed 31541010Bansal V, Shastri U, Canlas C, Gadsden JC. Diaphragm-Sparing Nerve Blocks for Shoulder Surgery: An Alternative Approach. Reg Anesth Pain Med. 2017 Jul/Aug;42(4):544-545. doi: 10.1097/AAP.0000000000000606. No abstract available.
PubMed 28632682Auyong DB, Hanson NA, Joseph RS, Schmidt BE, Slee AE, Yuan SC. Comparison of Anterior Suprascapular, Supraclavicular, and Interscalene Nerve Block Approaches for Major Outpatient Arthroscopic Shoulder Surgery: A Randomized, Double-blind, Noninferiority Trial. Anesthesiology. 2018 Jul;129(1):47-57. doi: 10.1097/ALN.0000000000002208.
PubMed 29634491Wiegel M, Moriggl B, Schwarzkopf P, Petroff D, Reske AW. Anterior Suprascapular Nerve Block Versus Interscalene Brachial Plexus Block for Shoulder Surgery in the Outpatient Setting: A Randomized Controlled Patient- and Assessor-Blinded Trial. Reg Anesth Pain Med. 2017 May/Jun;42(3):310-318. doi: 10.1097/AAP.0000000000000573.
PubMed 28257388
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anterior Suprascapular Nerve Block is as Effective as Interscalene Nerve Block and Causes Less Diapragm Paralysis in Arthroscopic Shoulder Surgery
- ClinicalTrials.gov ID
- NCT04626869
- Acronym / sponsor ID
- 2020.1234
- Conditions
- Diaphragm Paralysis Due to Local Anesthesia, Anterior Suprascapular Nerve Block, Analgesia, Arthroscopic Shoulder Surgery
- Keywords
- arthroscopic shoulder surgery, Interscalene nerve block, Anterior suprascapular nerve block, Analgesia, postoperative, Diaphragm paralysis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Alper Tunga DoganUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 15 Mar 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 13 Nov 2020 (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.
Interscalene block is still the gold standard in shoulder surgery analgesia. The most important side effect is diaphragm paralysis due to the phrenic nerve being affected. It may cause symptomatic dyspnea, especially in patients with limited respiratory capacity. There are studies showing that an effective analgesia, as much as the interscalene block can do, can be provided by blocking the suprascapular nerve in the neck region.
The aim of our study is to show that the anterior suprascapular block applied with ultra-low volume (5ml) in shoulder arthroscopy operations is at least as effective as the interscalene block and does not cause diaphragm paralysis.
Detailed description
Interscalene block is still the gold standard in shoulder surgery analgesia. The most important side effect is diaphragm paralysis due to the phrenic nerve being affected. It may cause symptomatic dyspnea, especially in patients with limited respiratory capacity. More distal brachial plexus blocks have been defined to avoid diaphragmatic paralysis . Thus, it is aimed to apply the local anesthetic drug further from the phrenic nerve. With the application of ultrasound, the amount of local anesthetic drug was reduced to less than 20 ml.
There are studies showing that an effective analgesia, as much as the interscalene block can do, can be provided by blocking the suprascapular nerve in the neck region. Although it has been shown in a cadaver study that the phrenic nerve can be stained after anterior suprascapular nerve block, the clinical effect is not fully known.
The effect of continuous local anesthetic drug administration on respiratory muscles through catheters placed in the peripheral nerve is another matter of concern. The method that will not affect the phrenic nerve at all and at the same time provide an effective analgesia is still under investigation.
The aim of our study is to show that the anterior suprascapular block applied with ultra-low volume (5ml) in shoulder arthroscopy operations is at least as effective as the interscalene block and does not cause diaphragm paralysis. One of the questions that our research aims to answer is how the continuous application of local anesthetic drugs affects the diaphragm muscle with the insertion of catheters in both regions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The patients will be divided into two groups as patients who underwent suprascapular nerve block with the supraclavicular approach and patients who underwent conventional interscalene nerve block. 5 ml of 0.5% Bupivacaine will be injected into both groups. Diaphragmatic movement will be evaluated with ultrasound at the right and left subcostal border with the patients in a semi-sitting position. The reduction in diaphragm motion will be calculated as the difference (in percent) in diaphragm motion measured before and 30 minutes after the block.
| Arm | Type | Receives |
|---|---|---|
| Interscalene block | Active comparator | Other: Evaluation of Diaphragm Movementpatients will be placed in a semi-sitting position with their heads facing the opposite side. Linear ultrasound probe (GE Loqic P9 7-15 MHz) to detect the brachial plexus. At the cervical level 5-6, the posterior brachial plexus will be approached as "in-plane" from the posterior with the needle (Contiplex C, Braun) through the catheter. The nerve structure will be confirmed with stimulation in the upper extremity muscles with a nerve stimulator and 5 ml 0.5% Bupivacaine will be injected. |
| Anterior suprascapular nerve block | Active comparator | Other: Evaluation of Diaphragm Movementpatients will be placed in a semi-sitting position with their heads facing the opposite side. Linear ultrasound probe (GE Loqic P9 7-15 MHz) will be placed in the suprascapular region in a coronal oblique manner. The omohyoid muscle, under it the suprascapular nerve, the brachial plexus and the subclavian artery will be identified. The suprascapular nerve will be approached from the posterior as "in-plane" with a needle (Contiplex C, Braun) through the catheter. The nerve structure will be confirmed by stimulation in the supraspinous muscle with a nerve stimulator and 5 ml 0.5% Bupivacaine will be injected. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients > 18 years old
- American Society of Anesthesiology (ASA) score of 1-3
- Scheduled for elective surgery.
Key exclusion criteria (8 listed)
- Patients with a condition that prevents peripheral nerve block
- Coagulopathies
- Chronic opioid use
- Stroke
- Polyneuropathy
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 |
|---|---|---|
| Evaluation of Diaphragm MovementDiaphragmatic movement will be evaluated with ultrasonography and a 5-2 MHz convex transducer will be used. The ultrasound probe is placed between the mid-clavicular line and the anterior axillary line by directing it vertically and slightly cranially. During quiet breathing and deep breathing, diaphragm movement will be measured. The reduction in diaphragm motion will be calculated as the difference (in percent) in diaphragm motion measured before and 30 minutes after the block. Each test will be done 3 times and the values will be averaged. A decrease between 75% and 100% will be defined as complete paresis, a decrease between 25% and 75% as partial paresis, and less than 25% decrease in diaphragmatic movement will be defined as no paresis. In order to investigate the effect of continuous local anesthetic drug administration on diaphragm movement via nerve catheter, the same procedure will be repeated 24 hours after surgery. | Other | Anterior suprascapular nerve block, Interscalene block |
Primary outcome
Pain rating
Time frame: the first postoperative 30 minutes
Measured by VAS. Postoperative 30 minutes
Pain rating
Time frame: Postoperative 6 hours
Measured by VAS. Postoperative 6 hours
Pain rating
Time frame: Postoperative 12 hours
Measured by VAS. Postoperative 12 hours
2 secondary outcomes
Diaphragmatic movements
Time frame: 30 minutes after the block application.
Diaphragmatic movements
Time frame: At the first postoperative 24 hours
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 30 Nov 2021.
- Results publication: PubMed 31541010Tran DQ, Layera S, Bravo D, Cristi-Sanchez I, Bermudez L, Aliste J. Diaphragm-sparing nerve blocks for shoulder surgery, revisited. Reg Anesth Pain Med. 2019 Sep 20:rapm-2019-100908. doi: 10.1136/rapm-2019-100908. Online ahead of print.
- Results publication: PubMed 28632682Bansal V, Shastri U, Canlas C, Gadsden JC. Diaphragm-Sparing Nerve Blocks for Shoulder Surgery: An Alternative Approach. Reg Anesth Pain Med. 2017 Jul/Aug;42(4):544-545. doi: 10.1097/AAP.0000000000000606. No abstract available.
- Results publication: PubMed 29634491Auyong DB, Hanson NA, Joseph RS, Schmidt BE, Slee AE, Yuan SC. Comparison of Anterior Suprascapular, Supraclavicular, and Interscalene Nerve Block Approaches for Major Outpatient Arthroscopic Shoulder Surgery: A Randomized, Double-blind, Noninferiority Trial. Anesthesiology. 2018 Jul;129(1):47-57. doi: 10.1097/ALN.0000000000002208.
- Results publication: PubMed 28257388Wiegel M, Moriggl B, Schwarzkopf P, Petroff D, Reske AW. Anterior Suprascapular Nerve Block Versus Interscalene Brachial Plexus Block for Shoulder Surgery in the Outpatient Setting: A Randomized Controlled Patient- and Assessor-Blinded Trial. Reg Anesth Pain Med. 2017 May/Jun;42(3):310-318. doi: 10.1097/AAP.0000000000000573.
- Individual participant dataSharing planned: No
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 Phase 4 study testing Evaluation of Diaphragm Movement in people with Diaphragm Paralysis Due to Local Anesthesia and Anterior Suprascapular Nerve Block, run by Alper Tunga Dogan 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 3 inclusion and 8 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 30 Nov 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Pain rating (time frame: the first postoperative 30 minutes). The study lists 3 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 NCT04626869, 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 30 Nov 2021.