Shoulder PainNCT06519851
Combined Shoulder Anterior Capsule and Suprascapular Nerve Block Versus Interscalene Block in Shoulder Surgery
A study testing suprascapular nerve block with 10 ml bupivacaine 0.25% & shoulder anterior capsule block with 30 ml bupivacaine 0.25% and Interscalene block with 20 ml bupivacaine 0.25% in people with Shoulder Pain, run by Assiut University.
Trial summary
The study aims to evaluate the postoperative analgesic effect of combined shoulder anterior capsule (SHAC) block with suprascapular nerve block (SSNB) versus Interscalene block (ISB) during the first 24 hours following shoulder surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- suprascapular nerve block with 10 ml bupivacaine 0.25% & shoulder anterior capsule block with 30 ml bupivacaine 0.25% and Interscalene block with 20 ml bupivacaine 0.25%
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- Aug 2024to Dec 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients of both genders
- patients aged 18-65 years
- BMI of less than 30
- American Society of Anesthesiologists (ASA) physical status I-II,
- Patients scheduled for unilateral shoulder surgery under general anesthesia.
Who cannot join
- Patient refusal
- BMI of 30 or more
- ASA III or more
- Pregnancy or breast feeding
- Uncooperative patients with communication difficulties, which might prevent a reliable postoperative assessment.
- Shoulder revision surgery
Show all 9Show fewer
- Pre-existing neurological deficits or neuropathy
- Known contraindications to peripheral nerve block, including local skin infections in the block procedure area, bleeding diathesis, coagulopathy
- Patients with chest problems not eligible for ISB
About this study
Official title: Combined Shoulder Anterior Capsule and Suprascapular Nerve Block Versus Interscalene Block in Shoulder Surgery: Randomized Controlled Clinical Trial
The study aims to evaluate the postoperative analgesic effect of combined shoulder anterior capsule (SHAC) block with suprascapular nerve block (SSNB) versus Interscalene block (ISB) during the first 24 hours following shoulder surgery.
Read the detailed description
Significant acute postoperative pain is common in adults after shoulder surgery, with approximately 45% reporting severe pain in the immediate postoperative period. This pain may necessitate opioid use for several days. The opioid requirement may be similar to that following gastrectomy or thoracotomy, and opioid-only analgesic techniques for shoulder surgery are commonly associated with opioid-related adverse effects such as nausea , vomiting, respiratory depression, pruritus, allergic reactions, sleep disturbance and constipation.
With the majority of these procedures being performed in the ambulatory setting, providing effective postoperative analgesia has become paramount in promoting quicker recovery and rehabilitation of these patients. Thus, alternative techniques are preferred. Nowadays, several ultrasound guided regional anesthesia methods are used for postoperative analgesia .
The shoulder is formed by two joints the acromioclavicular joint formed by the acromion process of the scapula and the clavicle, and the glenohumeral joint formed by the glenoid process of the scapula and the humeral head.
The shoulder joint is innervated by branches of the brachial plexus which include the suprascapular nerve, the axillary nerve, the subscapularis and lateral pectoral nerves .
The suprascapular nerve arises from the ventral rami of cervical nerve roots (C5 and C6), and it is a branch of the superior trunk of the brachial plexus. The suprascapular nerve is a mixed motor and sensory nerve providing motor innervation to the supraspinatus and infraspinatus muscles. And sensory innervation to the acromioclavicular joint, glenohumeral joint, and ligaments of the shoulder. The axillary nerve also originates from the ventral rami of C5 and C6 and it is a terminal branch of the brachial plexus. The axillary nerve is a mixed motor and sensory nerve providing motor innervation to the deltoid and sensory contributions to the glenohumeral joint . Other nerves involved in the sensory innervation of the shoulder joint include the nerve to subscapularis and the lateral pectoral nerve both of which arise from ventral rami of C5 and C6.
Cutaneous innervation is also important to consider in performing regional anesthesia. The cutaneous innervation of the shoulder is provided by branches of the brachial plexus with minor contributions from thoracic nerve roots. The supraclavicular nerve arises from cervical 3 and 4 nerve roots and provides cutaneous innervation to the cape of the shoulder. The axillary nerve provides cutaneous innervation over the lateral aspect of the shoulder.
Interscalene block which anesthetizes C5 and C6 nerve roots is the gold standard regional anesthesia technique for shoulder surgery but it carries a risk of ipsilateral phrenic nerve block and hemidiaphragmatic paralysis which limit its use in patients with preexisting pulmonary compromise. Less common complications included respiratory distress, weakness of the arm, hoarseness of voice, Horner's syndrome and brachial plexus neuropathy, rebound pain, and pneumothorax.Therefore, selecting the most appropriate brachial plexus block method is crucial to achieve effective pain control avoid complications.
Various diaphragm-sparing alternatives to interscalene blocks have been studied. Among them is the suprascapular nerve block (SSNB) which accounts for about 70% of the sensory innervation of the shoulder. Consequentially, it has been suggested that the SSNB will deliver adequate analgesia for shoulder surgery, but sometimes does not provide adequate analgesia because the axillary nerve, the lateral pectoral nerve, and sometimes the musculocutaneous nerve also contribute to the complex innervation of the shoulder joint.
By combining the (SSNB) with a recently described new block, the shoulder anterior capsular block (SHAC) , the investigator can reach all our targets. The SHAC is the combination of two different blocks. The first block is via the interfacial space between the deep layer of the deltoid fascia and the superficial layer of the subscapularis fascia, anterior to the subscapularis myotendinous junction, we can block both the axillary nerve and the subscapular nerves, the lateral pectoral nerve, and the musculocutaneous nerve. Second block, Pericapsular nerve group block (PENG) which is based in permeable spaces between the three glenohumeral ligaments as potential gateways. For example, it was suggested that deep pericapsular infiltration of local anesthetic towards the subscapularis may cover the axillary and subscapularis branches that feed the anteroinferior and superior quadrants of the glenohumeral joint by injecting the pericapsular space, reaching the terminal articular branches indistinctly from their origin.
- Conditions
- Shoulder Pain
- Being tested
- suprascapular nerve block with 10 ml bupivacaine 0.25% & shoulder anterior capsule block with 30 ml bupivacaine 0.25%, Interscalene block with 20 ml bupivacaine 0.25%
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
suprascapular nerve block with 10 ml bupivacaine 0.25% & shoulder anterior capsule block with 30 ml bupivacaine 0.25%Other
postoperative analgesic effect of combined shoulder anterior capsule (SHAC) block with suprascapular nerve block (SSNB) following shoulder surgery by ultrasound guided suprascapular nerve block (SSNB) with 10 ml bupivacaine 0.25% deep to the transverse scapular ligament and Shoulder anterior capsule (SHAC) block with 30 ml bupivacaine 0.25% (20 ml deep to the deltoid muscle between the deltoid and subscapularis tendon \&10mL in the pericapsular space)
Interscalene block with 20 ml bupivacaine 0.25%Other
postoperative analgesic effect of Interscalene block (ISB) following shoulder surgery by ultrasound guided interscalene brachial plexus block (ISB) with 20 ml bupivacaine 0.25% around C5-C6-C7 nerve roots of the brachial plexus
| Study group | Role | What they receive |
|---|---|---|
| • SSNB & SHAC | Active comparator | patients will receive general anesthesia + ultrasound guided suprascapular nerve block (SSNB) with 10 ml bupivacaine 0.25% deep to the transverse scapular ligament and Shoulder anterior capsule (SHAC) block with 30 ml bupivacaine 0.25% (20 ml deep to the deltoid muscle between the deltoid and subscapularis tendon \&10mL in the pericapsular space) Receives: Other: suprascapular nerve block with 10 ml bupivacaine 0.25% & shoulder anterior capsule block with 30 ml bupivacaine 0.25% |
| • Interscalene | Placebo comparator | patients will receive general anesthesia + ultrasound guided interscalene brachial plexus block (ISB) with 20 ml bupivacaine 0.25% around C5-C6-C7 nerve roots of the brachial plexus. Receives: Other: Interscalene block with 20 ml bupivacaine 0.25% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of postoperative analgesia measured by Visual analogue scale during the first 24 hours after shoulder surgery.
Visual analogue scale consists of a 10 centimeter line, with two end points representing 0 (no pain) and 10 (worst imaginable pain)
Measured: Pain will be assessed at 1st hour, then at 2, 6, 12, 18 and 24 hours postoperatively using VAS score.
Secondary outcomes (2)
The first time to rescue opioid analgesia, and the total opioid consumption in the first 24 hours postoperatively
The first time to rescue opioid analgesia, and the total opioid consumption in the first 24 hours postoperatively
Measured: 24 hours postoperatively
Any Complications related to the blocks
Any Complications related to the blocks as hemodynamic changes, hoarseness of voice, Horner syndrome, vascular injury, sensory or motor side effects.
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 posted25 Jul 2024
- Study startAug 2024 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dalia Mohamed Abbas, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06519851
- Sponsor's protocol ID
- SHAC & SSNB
- Status last verified
- Aug 2024
- First submitted
- 6 Jul 2024
- Last updated
- 6 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Shoulder Anterior Capsule and Suprascapular Nerve Block Versus Interscalene Block in Shoulder Surgery: Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06519851
- Acronym / sponsor ID
- SHAC & SSNB
- Conditions
- Shoulder Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Aug 2024 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 25 Jul 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.
The study aims to evaluate the postoperative analgesic effect of combined shoulder anterior capsule (SHAC) block with suprascapular nerve block (SSNB) versus Interscalene block (ISB) during the first 24 hours following shoulder surgery.
Detailed description
Significant acute postoperative pain is common in adults after shoulder surgery, with approximately 45% reporting severe pain in the immediate postoperative period. This pain may necessitate opioid use for several days. The opioid requirement may be similar to that following gastrectomy or thoracotomy, and opioid-only analgesic techniques for shoulder surgery are commonly associated with opioid-related adverse effects such as nausea , vomiting, respiratory depression, pruritus, allergic reactions, sleep disturbance and constipation.
With the majority of these procedures being performed in the ambulatory setting, providing effective postoperative analgesia has become paramount in promoting quicker recovery and rehabilitation of these patients. Thus, alternative techniques are preferred. Nowadays, several ultrasound guided regional anesthesia methods are used for postoperative analgesia .
The shoulder is formed by two joints the acromioclavicular joint formed by the acromion process of the scapula and the clavicle, and the glenohumeral joint formed by the glenoid process of the scapula and the humeral head.
The shoulder joint is innervated by branches of the brachial plexus which include the suprascapular nerve, the axillary nerve, the subscapularis and lateral pectoral nerves .
The suprascapular nerve arises from the ventral rami of cervical nerve roots (C5 and C6), and it is a branch of the superior trunk of the brachial plexus. The suprascapular nerve is a mixed motor and sensory nerve providing motor innervation to the supraspinatus and infraspinatus muscles. And sensory innervation to the acromioclavicular joint, glenohumeral joint, and ligaments of the shoulder. The axillary nerve also originates from the ventral rami of C5 and C6 and it is a terminal branch of the brachial plexus. The axillary nerve is a mixed motor and sensory nerve providing motor innervation to the deltoid and sensory contributions to the glenohumeral joint . Other nerves involved in the sensory innervation of the shoulder joint include the nerve to subscapularis and the lateral pectoral nerve both of which arise from ventral rami of C5 and C6.
Cutaneous innervation is also important to consider in performing regional anesthesia. The cutaneous innervation of the shoulder is provided by branches of the brachial plexus with minor contributions from thoracic nerve roots. The supraclavicular nerve arises from cervical 3 and 4 nerve roots and provides cutaneous innervation to the cape of the shoulder. The axillary nerve provides cutaneous innervation over the lateral aspect of the shoulder.
Interscalene block which anesthetizes C5 and C6 nerve roots is the gold standard regional anesthesia technique for shoulder surgery but it carries a risk of ipsilateral phrenic nerve block and hemidiaphragmatic paralysis which limit its use in patients with preexisting pulmonary compromise. Less common complications included respiratory distress, weakness of the arm, hoarseness of voice, Horner's syndrome and brachial plexus neuropathy, rebound pain, and pneumothorax.Therefore, selecting the most appropriate brachial plexus block method is crucial to achieve effective pain control avoid complications.
Various diaphragm-sparing alternatives to interscalene blocks have been studied. Among them is the suprascapular nerve block (SSNB) which accounts for about 70% of the sensory innervation of the shoulder. Consequentially, it has been suggested that the SSNB will deliver adequate analgesia for shoulder surgery, but sometimes does not provide adequate analgesia because the axillary nerve, the lateral pectoral nerve, and sometimes the musculocutaneous nerve also contribute to the complex innervation of the shoulder joint.
By combining the (SSNB) with a recently described new block, the shoulder anterior capsular block (SHAC) , the investigator can reach all our targets. The SHAC is the combination of two different blocks. The first block is via the interfacial space between the deep layer of the deltoid fascia and the superficial layer of the subscapularis fascia, anterior to the subscapularis myotendinous junction, we can block both the axillary nerve and the subscapular nerves, the lateral pectoral nerve, and the musculocutaneous nerve. Second block, Pericapsular nerve group block (PENG) which is based in permeable spaces between the three glenohumeral ligaments as potential gateways. For example, it was suggested that deep pericapsular infiltration of local anesthetic towards the subscapularis may cover the axillary and subscapularis branches that feed the anteroinferior and superior quadrants of the glenohumeral joint by injecting the pericapsular space, reaching the terminal articular branches indistinctly from their origin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| • SSNB & SHAC | Active comparator | Other: suprascapular nerve block with 10 ml bupivacaine 0.25% & shoulder anterior capsule block with 30 ml bupivacaine 0.25%patients will receive general anesthesia + ultrasound guided suprascapular nerve block (SSNB) with 10 ml bupivacaine 0.25% deep to the transverse scapular ligament and Shoulder anterior capsule (SHAC) block with 30 ml bupivacaine 0.25% (20 ml deep to the deltoid muscle between the deltoid and subscapularis tendon \&10mL in the pericapsular space) |
| • Interscalene | Placebo comparator | Other: Interscalene block with 20 ml bupivacaine 0.25%patients will receive general anesthesia + ultrasound guided interscalene brachial plexus block (ISB) with 20 ml bupivacaine 0.25% around C5-C6-C7 nerve roots of the brachial plexus. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients of both genders
- patients aged 18-65 years
- BMI of less than 30
- American Society of Anesthesiologists (ASA) physical status I-II,
- Patients scheduled for unilateral shoulder surgery under general anesthesia.
Key exclusion criteria (9 listed)
- Patient refusal
- BMI of 30 or more
- ASA III or more
- Pregnancy or breast feeding
- Uncooperative patients with communication difficulties, which might prevent a reliable postoperative assessment.
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 with 10 ml bupivacaine 0.25% & shoulder anterior capsule block with 30 ml bupivacaine 0.25%postoperative analgesic effect of combined shoulder anterior capsule (SHAC) block with suprascapular nerve block (SSNB) following shoulder surgery by ultrasound guided suprascapular nerve block (SSNB) with 10 ml bupivacaine 0.25% deep to the transverse scapular ligament and Shoulder anterior capsule (SHAC) block with 30 ml bupivacaine 0.25% (20 ml deep to the deltoid muscle between the deltoid and subscapularis tendon \&10mL in the pericapsular space) | Other | • SSNB & SHAC |
| Interscalene block with 20 ml bupivacaine 0.25%postoperative analgesic effect of Interscalene block (ISB) following shoulder surgery by ultrasound guided interscalene brachial plexus block (ISB) with 20 ml bupivacaine 0.25% around C5-C6-C7 nerve roots of the brachial plexus | Other | • Interscalene |
Primary outcome
Evaluation of postoperative analgesia measured by Visual analogue scale during the first 24 hours after shoulder surgery.
Time frame: Pain will be assessed at 1st hour, then at 2, 6, 12, 18 and 24 hours postoperatively using VAS score.
Visual analogue scale consists of a 10 centimeter line, with two end points representing 0 (no pain) and 10 (worst imaginable pain)
2 secondary outcomes
The first time to rescue opioid analgesia, and the total opioid consumption in the first 24 hours postoperatively
Time frame: 24 hours postoperatively
Any Complications related to the blocks
Time frame: 24 hours postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing suprascapular nerve block with 10 ml bupivacaine 0.25% & shoulder anterior capsule block with 30 ml bupivacaine 0.25% and Interscalene block with 20 ml bupivacaine 0.25% in people with Shoulder Pain, run by Assiut 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 5 inclusion and 9 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 Aug 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. Some participants in this study may receive a placebo. 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?
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?
Evaluation of postoperative analgesia measured by Visual analogue scale during the first 24 hours after shoulder surgery. (time frame: Pain will be assessed at 1st hour, then at 2, 6, 12, 18 and 24 hours postoperatively using VAS score.). 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 Aug 2024.