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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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 groups in NCT06519851
Study groupRoleWhat they receive
• SSNB & SHACActive comparatorpatients 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%
• InterscalenePlacebo comparatorpatients 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.

  1. 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)
  1. 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

  2. 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.

  1. First posted25 Jul 2024
  2. Study startAug 2024 (estimated)
  3. Primary completionJun 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

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)
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

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.

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