Interscalene Nerve BlockNCT05739201
ISB, SSNB, and PENG Block for Arthroscopic Shoulder Surgery
A study testing interscalene nerve block, anterior suprascapular nerve block and Peri-capsular nerve group block in people with Interscalene Nerve Block and Anterior Suprascapular Nerve Block, run by Tanta University at 1 site in Egypt.
Trial summary
This study is designed to investigate the post-operative analgesic effect of interscalene nerve block or anterior suprascapular nerve block compared to pericapsular nerve group block in patient undergoing elective arthroscopic shoulder surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Interscalene Nerve Block, Anterior Suprascapular Nerve Block, Arthroscopic Shoulder Surgery
- What is being tested?
- interscalene nerve block, anterior suprascapular nerve block and Peri-capsular nerve group block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Feb 2023to 20 Dec 2023
- 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
- Adult patients.
- ASA class I and II and scheduled for elective shoulder arthroscopy.
Who cannot join
- Patient who refuses the regional anesthesia technique.
- History of allergy to local anesthetics.
- Local infection at the site of the block.
- History of Pre-existing major organ dysfunction such as hepatic and renal failure.
- History of pre-existing lung disease (COPD, uncontrolled asthma).
- Preexisting upper extremity neurological abnormality or neuropathy.
- Difficulties in comprehending (NRS).
- Chronic opioid users (opioid intake more than 3 months).
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Shrouk Mohamed Elsawaf
Tanta, EL-Gharbia, 31527
Shrouk M Elsawaf, Master, 01091533902 ext. +20, Shroukms95@gmail.com
About this study
Official title: Comparative Study Between Interscalene Nerve Block, Anterior Suprascapular Nerve Block, and Pericapsular Nerve Group Block for Arthroscopic Shoulder Surgery
This study is designed to investigate the post-operative analgesic effect of interscalene nerve block or anterior suprascapular nerve block compared to pericapsular nerve group block in patient undergoing elective arthroscopic shoulder surgery.
Read the detailed description
Shoulder arthroscopy is a common outpatient operation with an increasing number of indications and complexity. Early postoperative pain immediately following shoulder surgery is a major concern and cause of distress for patients and orthopedic surgeons. Adequate pain control is vital for all aspects of the patient's recovery.
Nowadays, several ultrasound -guided regional anesthesia methods are used for postoperative analgesia. Regional techniques such as interscalene and supraclavicular blocks are usually preferred for shoulder analgesia. Interscalene brachial plexus block (ISB) is the gold standard technique in this area.
Suprascapular nerve block (SSB) has been proposed as an alternative to the ISB in providing analgesia for shoulder surgeries as it has a lower likelihood of causing phrenic nerve blockade.
The pericapsular nerve group (PENG) block has been suggested to be safely applied for analgesia and can be part of surgical anesthesia, but alone is not sufficient for anesthesia in shoulder surgery. The block of this area did not cause motor block or pulmonary complications, nor result in muscle laxity, blocking only the shoulder and the upper third of the humerus.
- Conditions
- Interscalene Nerve Block, Anterior Suprascapular Nerve Block, Arthroscopic Shoulder Surgery
- Being tested
- interscalene nerve block, anterior suprascapular nerve block, Peri-capsular nerve group block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interscalene nerve blockProcedure or surgery
Patients will receive interscalene nerve block, in which the patient will be in supine position with the head turned to the contralateral side using an ultrasound scan to identify the C5 and C6 nerve roots between the scalene muscles.15 ml of 0.25% Bupivacaine will be deposited between the C5 and C6 nerve roots, within the interscalene groove using a 22 gauge-regional block needle.
anterior suprascapular nerve blockProcedure or surgery
Patients will receive anterior suprascapular nerve block, in which the patient will be in supine position with the head turned to the contralateral side, using an ultrasound the nerve will be traced as it diverges from the brachial plexus to lie under the omohyoid muscle in the supraclavicular fossa. 15 ml of 0.25% Bupivacaine will be deposited lateral to the suprascapular nerve, underneath the omohyoid muscle using a 22 gauge-regional block needle.
Peri-capsular nerve group blockProcedure or surgery
Patients will receive PENG block, in which the patient will be in supine position and the patient's arm will be placed in external rotation and abducted at 45 degrees, using an ultrasound the humeral head, the tendon of the subscapularis muscle and the deltoid muscle over it will be defined, 15 ml of 0.25% Bupivacaine will be placed between the deltoid muscle and subscapularis tendon using a 22 gauge-regional block needle.
| Study group | Role | What they receive |
|---|---|---|
| Group (I) | Active comparator | 30 patients will receive interscalene nerve block. Receives: Procedure: interscalene nerve block |
| Group (II) | Active comparator | 30 Patients will receive anterior suprascapular nerve block. Receives: Procedure: anterior suprascapular nerve block |
| Group (III) | Active comparator | 30 atients will receive pericapsular nerve group block around shoulder surgery Receives: Procedure: Peri-capsular nerve group block |
What is being measured
The primary outcome is the main question the study is designed to answer.
the total opioid consumption.
Postoperative analgesia will be assessed by total opioid consumption and time till administration of first rescue analgesia will be recorded.
Measured: 24-hour postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2023
- Study start20 Feb 2023
- Primary completion20 Dec 2023 (estimated)
- Study completion20 Dec 2023 (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 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shrouk Elsawaf, Tanta University
- Investigators
- Ayman A Youssef, MD, Principal investigator, Professor of Anaesthesiology, Surgical Intensive Care and Pain Therapy, Faculty of Medicine, Tanta University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05739201
- Sponsor's protocol ID
- 36264MS18/1/23
- Status last verified
- Sep 2023
- First submitted
- 13 Feb 2023
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon reasonable request from the principal investigator
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Interscalene Nerve Block, Anterior Suprascapular Nerve Block, and Pericapsular Nerve Group Block for Arthroscopic Shoulder Surgery
- ClinicalTrials.gov ID
- NCT05739201
- Acronym / sponsor ID
- 36264MS18/1/23
- Conditions
- Interscalene Nerve Block, Anterior Suprascapular Nerve Block, Arthroscopic Shoulder Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 20 Feb 2023 (actual)
- Primary completion
- 20 Dec 2023 (estimated)
- Study completion
- 20 Dec 2023 (estimated)
- First posted
- 22 Feb 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.
This study is designed to investigate the post-operative analgesic effect of interscalene nerve block or anterior suprascapular nerve block compared to pericapsular nerve group block in patient undergoing elective arthroscopic shoulder surgery.
Detailed description
Shoulder arthroscopy is a common outpatient operation with an increasing number of indications and complexity. Early postoperative pain immediately following shoulder surgery is a major concern and cause of distress for patients and orthopedic surgeons. Adequate pain control is vital for all aspects of the patient's recovery.
Nowadays, several ultrasound -guided regional anesthesia methods are used for postoperative analgesia. Regional techniques such as interscalene and supraclavicular blocks are usually preferred for shoulder analgesia. Interscalene brachial plexus block (ISB) is the gold standard technique in this area.
Suprascapular nerve block (SSB) has been proposed as an alternative to the ISB in providing analgesia for shoulder surgeries as it has a lower likelihood of causing phrenic nerve blockade.
The pericapsular nerve group (PENG) block has been suggested to be safely applied for analgesia and can be part of surgical anesthesia, but alone is not sufficient for anesthesia in shoulder surgery. The block of this area did not cause motor block or pulmonary complications, nor result in muscle laxity, blocking only the shoulder and the upper third of the humerus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group (I) | Active comparator | Procedure: interscalene nerve block30 patients will receive interscalene nerve block. |
| Group (II) | Active comparator | Procedure: anterior suprascapular nerve block30 Patients will receive anterior suprascapular nerve block. |
| Group (III) | Active comparator | Procedure: Peri-capsular nerve group block30 atients will receive pericapsular nerve group block around shoulder surgery |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients.
- ASA class I and II and scheduled for elective shoulder arthroscopy.
Key exclusion criteria (8 listed)
- Patient who refuses the regional anesthesia technique.
- History of allergy to local anesthetics.
- Local infection at the site of the block.
- History of Pre-existing major organ dysfunction such as hepatic and renal failure.
- History of pre-existing lung disease (COPD, uncontrolled asthma).
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 nerve blockPatients will receive interscalene nerve block, in which the patient will be in supine position with the head turned to the contralateral side using an ultrasound scan to identify the C5 and C6 nerve roots between the scalene muscles.15 ml of 0.25% Bupivacaine will be deposited between the C5 and C6 nerve roots, within the interscalene groove using a 22 gauge-regional block needle. | Procedure or surgery | Group (I) |
| anterior suprascapular nerve blockPatients will receive anterior suprascapular nerve block, in which the patient will be in supine position with the head turned to the contralateral side, using an ultrasound the nerve will be traced as it diverges from the brachial plexus to lie under the omohyoid muscle in the supraclavicular fossa. 15 ml of 0.25% Bupivacaine will be deposited lateral to the suprascapular nerve, underneath the omohyoid muscle using a 22 gauge-regional block needle. | Procedure or surgery | Group (II) |
| Peri-capsular nerve group blockPatients will receive PENG block, in which the patient will be in supine position and the patient's arm will be placed in external rotation and abducted at 45 degrees, using an ultrasound the humeral head, the tendon of the subscapularis muscle and the deltoid muscle over it will be defined, 15 ml of 0.25% Bupivacaine will be placed between the deltoid muscle and subscapularis tendon using a 22 gauge-regional block needle. | Procedure or surgery | Group (III) |
Primary outcome
the total opioid consumption.
Time frame: 24-hour postoperatively
Postoperative analgesia will be assessed by total opioid consumption and time till administration of first rescue analgesia will be recorded.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
- Individual participant dataSharing planned: Yes. The data will be available upon reasonable request from the principal investigator
Related trials for Interscalene Nerve Block
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RecruitingObservational study
Evaluating Hemidiaphragmatic Paralysis With Prolonged Neural Blockade From an Interscalene Brachial Plexus Block
Shoulder Surgery, Shoulder Pain
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Combined Suprascapular and PECS I Blocks Versus Interscalene Block for Shoulder Arthroscopy
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Intravenous Dexamethasone With Single-Shot Versus Continuous Brachial Plexus Block for Rebound Pain After Shoulder Surgery
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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.
Ayman A Youssef, MD principal investigator
Professor of Anaesthesiology, Surgical Intensive Care and Pain Therapy, Faculty of Medicine, Tanta 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 nerve block, anterior suprascapular nerve block and Peri-capsular nerve group block in people with Interscalene Nerve Block and Anterior 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 2 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 6 Sep 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shrouk M Elsawaf, Master (+201091533902 ext. +20, Shroukms95@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the total opioid consumption. (time frame: 24-hour 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 6 Sep 2023.