Interscalene Nerve BlockNCT06674551
Suprascapular and Axillary Versus Interscalene Blocks Regarding Phrenic Affection in Shoulder Surgeries
A study testing Suprascapular nerve block and Axillary nerve block and Interscalene Nerve Block in people with Interscalene Nerve Block and Suprascapular Nerve, run by Ain Shams University.
Trial summary
This study is aims to compare between combined suprascapular and axillary nerve blocks versus interscalene nerve block regarding phrenic nerve affection assessed by ultrasound guided diaphragmatic excursion in shoulder arthroscopy surgeries. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Interscalene Nerve Block, Suprascapular Nerve, Shoulder Surgery
- What is being tested?
- Suprascapular nerve block and Axillary nerve block and Interscalene Nerve Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 20 Nov 2024to 1 Nov 2025
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients aged between 18 - 60 years old.
- Both sexes.
- ASA physical status classes I - II.
- Body mass index: 18-35 kg/ m2.
Who cannot join
- Infection at site of injection.
- Psychiatric illness.
- Central Nervous System Diseases like (epilepsy, stroke …etc.) or neurological disease affecting patient's upper limb.
- Dependence on opiates and psycho-dynamic medications.
- Moderate to severe pulmonary disease.
- Coagulopathy and bleeding disorders.
- Allergies to drug used (Bupivacaine 0.5%).
- Previous surgery at site of injection and history of radiotherapy.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparative Study Between Combined Suprascapular and Axillary Nerve Blocks Versus Interscalene Nerve Block Regarding Phrenic Nerve Affection Assessed by Ultrasound Guided Diaphragmatic Excursion in Shoulder Arthroscopy Surgeries
This study is aims to compare between combined suprascapular and axillary nerve blocks versus interscalene nerve block regarding phrenic nerve affection assessed by ultrasound guided diaphragmatic excursion in shoulder arthroscopy surgeries.
Read the detailed description
Interscalene approach of brachial plexus nerve block is recognized as the gold standard technique for postoperative pain control after shoulder arthroscopy surgeries . However, it is associated with major adverse effects and possibly critical complications including phrenic nerve affection. Combined suprascapular and axillary nerve blocks are considered to be a safe and effective alternative to interscalene nerve block for shoulder surgery. Futher studies had been done regarding postoperative analgesia after shoulder arthroscopy surgeries using intersalene nerve block versus suprascapular and axillary nerve blocks.
In this study, we will Compare between combined suprascapular and axillary nerve blocks vs interscalene nerve block regarding objective phrenic nerve affection known as a serious complication of interscalene nerve block.
- Being tested
- Suprascapular nerve block and Axillary nerve block, Interscalene Nerve Block
- Keywords
- interscalene nerve block, axillary nerve block, shoulder surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suprascapular nerve block and Axillary nerve blockProcedure or surgery
A linear ultrasound probe will be placed in a sagittal plane at the superior medial border of the scapula. The probe will be moved laterally and then placed parallel to the scapular spine. when the needle tip contacts the bone just medial to the spinoglenoid notch and after confirmation of absence of vascular structure by color Doppler, 10 ml of 0.5% bupivacaine will be injected with aspiration every 3 ml to avoid intravascular injection and the spread of the local anaesthetic
Interscalene Nerve BlockProcedure or surgery
The ultrasound probe will be placed in the supraclavicular fossa in a transverse orientation, aimed caudad into the thoracic cavity, to visualize the brachial plexus near the subclavian artery. Once identified, the plexus will be followed cephalad where it is found within the brachial plexus fascial sheath in the interscalene groove.
| Study group | Role | What they receive |
|---|---|---|
| Suprascapular nerve block and Axillary nerve block ( Group A) | Experimental | Patients will receive Suprascapular nerve block (SSNB) and Axillary nerve block (AXNB) 30 minutes before the induction of general anaesthesia. Receives: Procedure: Suprascapular nerve block and Axillary nerve block |
| Interscalene nerve block (Group B) | Experimental | Patients will receive Interscalene nerve block (ISB) 30 minutes before the induction of general anaesthesia. Receives: Procedure: Interscalene Nerve Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of hemidiaphragmatic paralysis measured by ultrasound.
defined as a ≥ 25% reduction in diaphragmatic excursion measured by ultrasound.
Measured: measurement will be taken 8 hours after the performance of the block for fourth and last time.
Secondary outcomes (1)
postoperative pain using NRS
is to measure first rescue analgesia postoperative (24 hours)
Measured: 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start20 Nov 2024 (estimated)
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interscalene Nerve BlockStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06674551
- Sponsor's protocol ID
- FMASU MD128/2024
- Status last verified
- Sep 2024
- First submitted
- 1 Oct 2024
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Combined Suprascapular and Axillary Nerve Blocks Versus Interscalene Nerve Block Regarding Phrenic Nerve Affection Assessed by Ultrasound Guided Diaphragmatic Excursion in Shoulder Arthroscopy Surgeries
- ClinicalTrials.gov ID
- NCT06674551
- Acronym / sponsor ID
- FMASU MD128/2024
- Keywords
- interscalene nerve block, axillary nerve block, shoulder surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 20 Nov 2024 (estimated)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 5 Nov 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.
This study is aims to compare between combined suprascapular and axillary nerve blocks versus interscalene nerve block regarding phrenic nerve affection assessed by ultrasound guided diaphragmatic excursion in shoulder arthroscopy surgeries.
Detailed description
Interscalene approach of brachial plexus nerve block is recognized as the gold standard technique for postoperative pain control after shoulder arthroscopy surgeries . However, it is associated with major adverse effects and possibly critical complications including phrenic nerve affection. Combined suprascapular and axillary nerve blocks are considered to be a safe and effective alternative to interscalene nerve block for shoulder surgery. Futher studies had been done regarding postoperative analgesia after shoulder arthroscopy surgeries using intersalene nerve block versus suprascapular and axillary nerve blocks.
In this study, we will Compare between combined suprascapular and axillary nerve blocks vs interscalene nerve block regarding objective phrenic nerve affection known as a serious complication of interscalene nerve block.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suprascapular nerve block and Axillary nerve block ( Group A) | Experimental | Procedure: Suprascapular nerve block and Axillary nerve blockPatients will receive Suprascapular nerve block (SSNB) and Axillary nerve block (AXNB) 30 minutes before the induction of general anaesthesia. |
| Interscalene nerve block (Group B) | Experimental | Procedure: Interscalene Nerve BlockPatients will receive Interscalene nerve block (ISB) 30 minutes before the induction of general anaesthesia. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients aged between 18 - 60 years old.
- Both sexes.
- ASA physical status classes I - II.
- Body mass index: 18-35 kg/ m2.
Key exclusion criteria (8 listed)
- Infection at site of injection.
- Psychiatric illness.
- Central Nervous System Diseases like (epilepsy, stroke …etc.) or neurological disease affecting patient's upper limb.
- Dependence on opiates and psycho-dynamic medications.
- Moderate to severe pulmonary disease.
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 |
|---|---|---|
| Suprascapular nerve block and Axillary nerve blockA linear ultrasound probe will be placed in a sagittal plane at the superior medial border of the scapula. The probe will be moved laterally and then placed parallel to the scapular spine. when the needle tip contacts the bone just medial to the spinoglenoid notch and after confirmation of absence of vascular structure by color Doppler, 10 ml of 0.5% bupivacaine will be injected with aspiration every 3 ml to avoid intravascular injection and the spread of the local anaesthetic | Procedure or surgery | Suprascapular nerve block and Axillary nerve block ( Group A) |
| Interscalene Nerve BlockThe ultrasound probe will be placed in the supraclavicular fossa in a transverse orientation, aimed caudad into the thoracic cavity, to visualize the brachial plexus near the subclavian artery. Once identified, the plexus will be followed cephalad where it is found within the brachial plexus fascial sheath in the interscalene groove. | Procedure or surgery | Interscalene nerve block (Group B) |
Primary outcome
incidence of hemidiaphragmatic paralysis measured by ultrasound.
Time frame: measurement will be taken 8 hours after the performance of the block for fourth and last time.
defined as a ≥ 25% reduction in diaphragmatic excursion measured by ultrasound.
1 secondary outcome
postoperative pain using NRS
Time frame: 24 hours postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
Related trials for Interscalene Nerve Block
Not yet recruiting
Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
Postoperative Pain, Shoulder Arthroscopy
RecruitingObservational study
Evaluating Hemidiaphragmatic Paralysis With Prolonged Neural Blockade From an Interscalene Brachial Plexus Block
Shoulder Surgery, Shoulder Pain
Not yet recruiting
Combined Suprascapular and PECS I Blocks Versus Interscalene Block for Shoulder Arthroscopy
Postoperative Pain, Hemidiaphragmatic Paresis
RecruitingPhase 4
Intravenous Dexamethasone With Single-Shot Versus Continuous Brachial Plexus Block for Rebound Pain After Shoulder Surgery
Pain, Postoperative, Rebound Pain
Recruiting
Anterior Suprascapular Versus Interscalene Block for Postoperative Analgesia After Arthroscopic Shoulder Surgery in the Outpatient Setting
Postoperative Pain, Acute
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.
Questions about this trial
What is this clinical trial studying?
A study testing Suprascapular nerve block and Axillary nerve block and Interscalene Nerve Block in people with Interscalene Nerve Block and Suprascapular Nerve, run by Ain Shams University.
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 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: status not confirmed, as of the sponsor's last update on 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Khaled Mahmoud, Master (+201211880428, midoabbas2019@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of hemidiaphragmatic paralysis measured by ultrasound. (time frame: measurement will be taken 8 hours after the performance of the block for fourth and last time.). 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 5 Nov 2024.