Interscalene BlockNCT07090733
Ultrasound Guided Interscalene, Suprascapular and Anterior Glenoid Nerve Blocks on Diaphragmatic Excursion and Analgesia Following Arthroscopic Shoulder Surgery
A study testing Interscalene brachial plexus block, Suprascapular nerve block and Anterior glenoid block in people with Interscalene Block and Suprascapular Nerve Block, run by Tanta University at 1 site in Egypt.
Trial summary
This study aims to evaluate the diaphragmatic movement and postoperative analgesia following anterior glenoid, suprascapular, and interscalene nerve blocks in patients undergoing elective arthroscopic shoulder surgery. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Interscalene Block, Suprascapular Nerve Block, Anterior Glenoid Nerve Block
- What is being tested?
- Interscalene brachial plexus block, Suprascapular nerve block and Anterior glenoid block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 21 to 65 years.
- Both sexes.
- American Society of Anesthesiologists (ASA) physical status I or II.
- Scheduled for arthroscopic shoulder surgery.
Who cannot join
- Patient's refusal to participate.
- Patients with a history of allergy to local anesthetics.
- Patients with a history of chronic use of painkillers.
- Patients presented with mental dysfunction.
- Patients with coagulation disorders.
- Patients presented with skin or soft tissue infection at the proposed site of needle Insertion.
- Pregnant Patients.
- Patients with Chronic Obstructive Pulmonary Disease (COPD) or a Body Mass Index (BMI) of more than 40.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University
Tanta, El-Gharbia, 31527
Fatma E Elsamahy, Master, 00201094082899, Drfatmaelsamahy@gmail.com
Osama M Shalaby, MD
About this study
Official title: The Effect of Ultrasound Guided Interscalene, Suprascapular and Anterior Glenoid Nerve Blocks on Diaphragmatic Excursion and Analgesia Following Arthroscopic Shoulder Surgery: A Prospective Randomized Controlled Study
This study aims to evaluate the diaphragmatic movement and postoperative analgesia following anterior glenoid, suprascapular, and interscalene nerve blocks in patients undergoing elective arthroscopic shoulder surgery.
Read the detailed description
Arthroscopic shoulder surgery is a key approach for diagnosing and treating many shoulder disorders. Nevertheless, 30-70% of patients often experience moderate to severe pain, especially at 48 h after the operation, which affects rapid recovery.
The interscalene brachial plexus block (ISB) remains the gold standard for providing analgesia after shoulder surgery. Suprascapular nerve block (SSNB) is the most commonly used regional nerve block. Seventy percent of the sensory nerve fibers of the shoulder joint are innervated by the suprascapular nerve (SSN), with the supraspinatus and infraspinatus being directly innervated by the SSN.
- Conditions
- Interscalene Block, Suprascapular Nerve Block, Anterior Glenoid Nerve Block, Diaphragmatic Excursion, Analgesia, Arthroscopic Shoulder Surgery
- Being tested
- Interscalene brachial plexus block, Suprascapular nerve block, Anterior glenoid block, Suprascapular nerve block + Anterior glenoid block
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interscalene brachial plexus blockOther
Also called 15 ml of 0.25% bupivacaine
Patients will receive general anesthesia, plus an ultrasound-guided interscalene brachial plexus block (ISB) with the injection of 15 mL of 0.25% bupivacaine.
Suprascapular nerve blockOther
Also called 15 ml of 0.25% bupivacaine
Patients will receive general anesthesia plus an ultrasound-guided suprascapular nerve block (SSNB) with injection of 15 ml of 0.25% bupivacaine.
Anterior glenoid blockOther
Also called 15 ml of 0.25% bupivacaine
Patients will receive general anesthesia plus an ultrasound-guided anterior glenoid block with injection of 15 ml of 0.25% bupivacaine.
Suprascapular nerve block + Anterior glenoid blockOther
Also called 30 mL of 0.25% bupivacaine
Patients will receive general anesthesia, along with a total volume of 30 mL of 0.25% bupivacaine, divided into 15 mL for ultrasound-guided SSNB and 15 mL for ultrasound-guided anterior glenoid block.
| Study group | Role | What they receive |
|---|---|---|
| Group I | Active comparator | Patients will receive general anesthesia, plus an ultrasound-guided Interscalene brachial plexus block (ISB) with the injection of 15 mL of 0.25% bupivacaine.
Patients will receive general anesthesia plus an ultrasound-guided suprascapular nerve block (SSNB) Receives: Other: Interscalene brachial plexus block |
| Group II | Experimental | Patients will receive general anesthesia plus an ultrasound-guided suprascapular nerve block (SSNB) with injection of 15 ml of 0.25% bupivacaine. Receives: Other: Suprascapular nerve block |
| Group III | Experimental | Patients will receive general anesthesia plus an ultrasound-guided anterior glenoid block with injection of 15 ml of 0.25% bupivacaine. Receives: Other: Anterior glenoid block |
| Group IV | Experimental | Patients will receive general anesthesia, along with a total volume of 30 mL of bupivacaine 0.25%, divided into 15 mL of Bupivacaine 0.25% for ultrasound-guided SSNB and 15 mL of Bupivacaine 0.25% for ultrasound-guided anterior glenoid block. Receives: Other: Suprascapular nerve block + Anterior glenoid block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hemi-diaphragmatic paralysis
Incidence of hemi-diaphragmatic paralysis determined by ultrasound-guided assessment of diaphragmatic excursion. Diaphragmatic excursion will be measured before procedure (pre-block), 30 minutes after performing the block and post operative after complete recovery in post-anesthesia care unit (PACU).
Measured: 24 hours postoperatively
Secondary outcomes (3)
Degree of pain
Each patient will be instructed about postoperative pain assessment with the numerical rating scale (NRS) score. NRS (0 represents "no pain" while 10 represents "the worst pain imaginable"). NRS will be recorded at T0, 30 min, 2, 4, 6, 12, 18, and 24 hours postoperatively.
Measured: 24 hours postoperatively
Total analgesic consumption
All patients will receive Paracetamol 1 g/6 hours as a regular analgesia and Morphine 3mg if the numerical rating scale (NRS) > 3 as a rescue analgesia.
Measured: 24 hours postoperatively
Degree of patient satisfaction
The degree of patient satisfaction will be assessed based on a questionnaire and graded on a 4-point scale (excellent/good/fair/poor)
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 posted29 Jul 2025
- Study start1 Jan 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interscalene BlockStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Elsamahy, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07090733
- Sponsor's protocol ID
- 36265MD/12/24
- Status last verified
- Jul 2025
- First submitted
- 21 Jul 2025
- Last updated
- 29 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ultrasound Guided Interscalene, Suprascapular and Anterior Glenoid Nerve Blocks on Diaphragmatic Excursion and Analgesia Following Arthroscopic Shoulder Surgery: A Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07090733
- Acronym / sponsor ID
- 36265MD/12/24
- Conditions
- Interscalene Block, Suprascapular Nerve Block, Anterior Glenoid Nerve Block, Diaphragmatic Excursion, Analgesia, Arthroscopic Shoulder Surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 29 Jul 2025 (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 aims to evaluate the diaphragmatic movement and postoperative analgesia following anterior glenoid, suprascapular, and interscalene nerve blocks in patients undergoing elective arthroscopic shoulder surgery.
Detailed description
Arthroscopic shoulder surgery is a key approach for diagnosing and treating many shoulder disorders. Nevertheless, 30-70% of patients often experience moderate to severe pain, especially at 48 h after the operation, which affects rapid recovery.
The interscalene brachial plexus block (ISB) remains the gold standard for providing analgesia after shoulder surgery. Suprascapular nerve block (SSNB) is the most commonly used regional nerve block. Seventy percent of the sensory nerve fibers of the shoulder joint are innervated by the suprascapular nerve (SSN), with the supraspinatus and infraspinatus being directly innervated by the SSN.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group I | Active comparator | Other: Interscalene brachial plexus blockPatients will receive general anesthesia, plus an ultrasound-guided Interscalene brachial plexus block (ISB) with the injection of 15 mL of 0.25% bupivacaine. Patients will receive general anesthesia plus an ultrasound-guided suprascapular nerve block (SSNB) |
| Group II | Experimental | Other: Suprascapular nerve blockPatients will receive general anesthesia plus an ultrasound-guided suprascapular nerve block (SSNB) with injection of 15 ml of 0.25% bupivacaine. |
| Group III | Experimental | Other: Anterior glenoid blockPatients will receive general anesthesia plus an ultrasound-guided anterior glenoid block with injection of 15 ml of 0.25% bupivacaine. |
| Group IV | Experimental | Other: Suprascapular nerve block + Anterior glenoid blockPatients will receive general anesthesia, along with a total volume of 30 mL of bupivacaine 0.25%, divided into 15 mL of Bupivacaine 0.25% for ultrasound-guided SSNB and 15 mL of Bupivacaine 0.25% for ultrasound-guided anterior glenoid block. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age from 21 to 65 years.
- Both sexes.
- American Society of Anesthesiologists (ASA) physical status I or II.
- Scheduled for arthroscopic shoulder surgery.
Key exclusion criteria (8 listed)
- Patient's refusal to participate.
- Patients with a history of allergy to local anesthetics.
- Patients with a history of chronic use of painkillers.
- Patients presented with mental dysfunction.
- Patients with coagulation disorders.
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 brachial plexus blockAlso: 15 ml of 0.25% bupivacainePatients will receive general anesthesia, plus an ultrasound-guided interscalene brachial plexus block (ISB) with the injection of 15 mL of 0.25% bupivacaine. | Other | Group I |
| Suprascapular nerve blockAlso: 15 ml of 0.25% bupivacainePatients will receive general anesthesia plus an ultrasound-guided suprascapular nerve block (SSNB) with injection of 15 ml of 0.25% bupivacaine. | Other | Group II |
| Anterior glenoid blockAlso: 15 ml of 0.25% bupivacainePatients will receive general anesthesia plus an ultrasound-guided anterior glenoid block with injection of 15 ml of 0.25% bupivacaine. | Other | Group III |
| Suprascapular nerve block + Anterior glenoid blockAlso: 30 mL of 0.25% bupivacainePatients will receive general anesthesia, along with a total volume of 30 mL of 0.25% bupivacaine, divided into 15 mL for ultrasound-guided SSNB and 15 mL for ultrasound-guided anterior glenoid block. | Other | Group IV |
Primary outcome
Incidence of hemi-diaphragmatic paralysis
Time frame: 24 hours postoperatively
Incidence of hemi-diaphragmatic paralysis determined by ultrasound-guided assessment of diaphragmatic excursion. Diaphragmatic excursion will be measured before procedure (pre-block), 30 minutes after performing the block and post operative after complete recovery in post-anesthesia care unit (PACU).
3 secondary outcomes
Degree of pain
Time frame: 24 hours postoperatively
Total analgesic consumption
Time frame: 24 hours postoperatively
Degree of patient satisfaction
Time frame: 24 hours postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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Addition of a Pectoserratus Block to Interscalene Block in Patients Undergoing Total Shoulder Replacement
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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.
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 brachial plexus block, Suprascapular nerve block and Anterior glenoid block in people with Interscalene Block and Suprascapular Nerve Block, run by Tanta 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 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: looking for participants now, as of the sponsor's last update on 29 Jul 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fatma E Elsamahy, Master (00201094082899, Drfatmaelsamahy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of hemi-diaphragmatic paralysis (time frame: 24 hours 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 29 Jul 2025.