Shoulder SurgeryNCT06396455
Ultrasound Guided Suprascapular Nerve Block Versus ISB Block in Arthroscopic Shoulder Surgery
A study testing interscalene block group and Suprascapular nerve block group in people with Shoulder Surgery, run by Benha University at 1 site in Egypt.
Trial summary
Diaphragmatic dysfunction can be detected as a decrease in forced vital capacity (FVC) and forced expiratory volume at 1 s (FEV1) on spirometry or as lower diaphragmatic excursion (DE) on US, the latter having become the gold standard in thoracic assessment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Shoulder Surgery
- What is being tested?
- interscalene block group and Suprascapular nerve block group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 26 Jan 2023to 4 Apr 2024
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged (18-65 years)
- American Society of Anesthesiologists (ASA) physical status I or II
- scheduled for elective arthroscopic shoulder surgery
Who cannot join
- pre-existing respiratory,
- cardiac, renal, neurological, or hepatic disease, neuropathy affecting brachial plexus
- contraindication to peripheral nerve block (e.g., coagulopathy),
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison Between Ultrasound Guided Suprascapular Nerve Block Versus Ultrasound Guided Interscalene Brachial Plexus Block on Respiratory Mechanics in Patients Undergoing Arthroscopic Shoulder Surgery: A Randomized Controlled Study
Diaphragmatic dysfunction can be detected as a decrease in forced vital capacity (FVC) and forced expiratory volume at 1 s (FEV1) on spirometry or as lower diaphragmatic excursion (DE) on US, the latter having become the gold standard in thoracic assessment.
Read the detailed description
Severe intraoperative and postoperative pain associated with arthroscopic shoulder surgery has high incidence reaching up to 45%; it is often significant enough to interfere with initial recovery and rehabilitation.
Shoulder arthroscopy is becoming more common, representing the second most common Orthopedic surgery after knee arthroscopy . Interscalene brachial plexus block (ISB) is the gold standard analgesic technique for shoulder surgeries with success rates of 87% to 100%, but it also blocks the phrenic nerve (C3-C5).
Suprascapular nerve block via the anterior approach (SSB-A) is performed distally at the trunk/division level of the brachial plexus, thereby potentially sparing the phrenic nerve and minimising many adverse effects of ISB
- Conditions
- Shoulder Surgery
- Being tested
- interscalene block group, Suprascapular nerve block group
- Keywords
- Anterior Suprascapular Nerve Block, Suprascapular Nerve Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interscalene block groupProcedure or surgery
Also called Group ISB
The ISB group scanning was done by linear ultrasound probe just below the level of the cricoid cartilage medial to the sternocleidomastoid muscle; the skin was disinfected, and the transducer was positioned in the transverse plane to identify the carotid artery. Once the artery was identified, the transducer was moved slightly laterally across the neck to identify the scalene muscles and the brachial plexus that is present between the anterior and middle scalene muscles. 3 ml lidocaine 1% was injected at puncture site The needle was then inserted in-plane toward the brachial plexus, in a lateral-to-medial direction. After a careful aspiration, 20 ml of bupivacaine 0.25% was injected.
Suprascapular nerve block groupProcedure or surgery
Also called group SSNB
After cleaning the skin with an antiseptic solution, an ultrasound probe was put in sagittal orientation at the superior medial border of the scapula to identify the pleura and then moved laterally; when it was parallel to the spine of the scapula, the transducer was moved cephalad and the suprascapular fossa was identified, and then the transducer was moved lateral to locate the suprascapular notch. The suprascapular nerve was a round hyperechoic structure beneath the transverse scapular ligament in the scapular notch. 3 ml lidocaine 1% was injected at puncture site then the needle was inserted along the longitudinal axis of the ultrasound beam, and 10 ml of bupivacaine 0.25% was injected.
| Study group | Role | What they receive |
|---|---|---|
| interscalene block group | Experimental | patients received an ultrasound guided interscalene approach of brachial plexus plane block Receives: Procedure: interscalene block group |
| suprascapular nerve block group | Experimental | patients received ultrasound guided suprascapular nerve block. Receives: Procedure: Suprascapular nerve block group |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analogue score
The visual analogue score (VAS) was used (0 indicating no pain and 10 indicating worst unbearable pain) at rest and upon flexion for assessment of pain intensity upon arrival to the PACU
Measured: Postoperative pain was assessed using VAS at Postoperative care unit, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, and 24hours after block administration postoperatively
Secondary outcomes (1)
Patient satisfaction
Patient satisfaction was evaluated using 5-point Likert scale) (1=extremely dissatisfied; 5=extremely satisfied)
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start26 Jan 2023
- Primary completion28 Mar 2024
- Study completion4 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder SurgeryStudies of the same condition, open and under way.
- More trials run by Benha 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
- Model description
- Group ISB (interscalene block group) received an ultrasound guided interscalene approach of brachial plexus plane block and group SSNB (suprascapular nerve block) received ultrasound guided suprascapular nerve block.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ramy Mousa, Benha University
- Investigators
- Ramy Saleh, MD, Principal investigator, Anesthesia and surgical ICU department, Faculty of Medicine, Benha University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06396455
- Sponsor's protocol ID
- RC 16-1-2024
- Status last verified
- Apr 2024
- First submitted
- 24 Apr 2024
- Last updated
- 2 May 2024
- 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 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Between Ultrasound Guided Suprascapular Nerve Block Versus Ultrasound Guided Interscalene Brachial Plexus Block on Respiratory Mechanics in Patients Undergoing Arthroscopic Shoulder Surgery: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06396455
- Acronym / sponsor ID
- RC 16-1-2024
- Conditions
- Shoulder Surgery
- Keywords
- Anterior Suprascapular Nerve Block, Suprascapular Nerve Block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 26 Jan 2023 (actual)
- Primary completion
- 28 Mar 2024 (actual)
- Study completion
- 4 Apr 2024 (actual)
- First posted
- 2 May 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.
Diaphragmatic dysfunction can be detected as a decrease in forced vital capacity (FVC) and forced expiratory volume at 1 s (FEV1) on spirometry or as lower diaphragmatic excursion (DE) on US, the latter having become the gold standard in thoracic assessment.
Detailed description
Severe intraoperative and postoperative pain associated with arthroscopic shoulder surgery has high incidence reaching up to 45%; it is often significant enough to interfere with initial recovery and rehabilitation.
Shoulder arthroscopy is becoming more common, representing the second most common Orthopedic surgery after knee arthroscopy . Interscalene brachial plexus block (ISB) is the gold standard analgesic technique for shoulder surgeries with success rates of 87% to 100%, but it also blocks the phrenic nerve (C3-C5).
Suprascapular nerve block via the anterior approach (SSB-A) is performed distally at the trunk/division level of the brachial plexus, thereby potentially sparing the phrenic nerve and minimising many adverse effects of ISB
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Group ISB (interscalene block group) received an ultrasound guided interscalene approach of brachial plexus plane block and group SSNB (suprascapular nerve block) received ultrasound guided suprascapular nerve block.
| Arm | Type | Receives |
|---|---|---|
| interscalene block group | Experimental | Procedure: interscalene block grouppatients received an ultrasound guided interscalene approach of brachial plexus plane block |
| suprascapular nerve block group | Experimental | Procedure: Suprascapular nerve block grouppatients received ultrasound guided suprascapular nerve block. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- aged (18-65 years)
- American Society of Anesthesiologists (ASA) physical status I or II
- scheduled for elective arthroscopic shoulder surgery
Key exclusion criteria (3 listed)
- pre-existing respiratory,
- cardiac, renal, neurological, or hepatic disease, neuropathy affecting brachial plexus
- contraindication to peripheral nerve block (e.g., coagulopathy),
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 block groupAlso: Group ISBThe ISB group scanning was done by linear ultrasound probe just below the level of the cricoid cartilage medial to the sternocleidomastoid muscle; the skin was disinfected, and the transducer was positioned in the transverse plane to identify the carotid artery. Once the artery was identified, the transducer was moved slightly laterally across the neck to identify the scalene muscles and the brachial plexus that is present between the anterior and middle scalene muscles. 3 ml lidocaine 1% was injected at puncture site The needle was then inserted in-plane toward the brachial plexus, in a lateral-to-medial direction. After a careful aspiration, 20 ml of bupivacaine 0.25% was injected. | Procedure or surgery | interscalene block group |
| Suprascapular nerve block groupAlso: group SSNBAfter cleaning the skin with an antiseptic solution, an ultrasound probe was put in sagittal orientation at the superior medial border of the scapula to identify the pleura and then moved laterally; when it was parallel to the spine of the scapula, the transducer was moved cephalad and the suprascapular fossa was identified, and then the transducer was moved lateral to locate the suprascapular notch. The suprascapular nerve was a round hyperechoic structure beneath the transverse scapular ligament in the scapular notch. 3 ml lidocaine 1% was injected at puncture site then the needle was inserted along the longitudinal axis of the ultrasound beam, and 10 ml of bupivacaine 0.25% was injected. | Procedure or surgery | suprascapular nerve block group |
Primary outcome
visual analogue score
Time frame: Postoperative pain was assessed using VAS at Postoperative care unit, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, and 24hours after block administration postoperatively
The visual analogue score (VAS) was used (0 indicating no pain and 10 indicating worst unbearable pain) at rest and upon flexion for assessment of pain intensity upon arrival to the PACU
1 secondary outcome
Patient satisfaction
Time frame: 24 hours postoperatively
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 2 May 2024.
- 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.
Ramy Saleh, MD principal investigator
Anesthesia and surgical ICU department, Faculty of Medicine, Benha University, Egypt
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 group and Suprascapular nerve block group in people with Shoulder Surgery, run by Benha University at 1 site in Egypt.
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 3 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 2 May 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 Egypt. 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?
visual analogue score (time frame: Postoperative pain was assessed using VAS at Postoperative care unit, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, and 24hours after block administration postoperatively). 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 2 May 2024; AzTrials last refreshed its copy on 7 Nov 2026.