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Arthroscopic Rotator Cuff RepairNCT06969625

Shoulder Anterior Capsular Block for Postoperative Analgesia in Arthroscopic Rotator Cuff Repair Surgery

A study testing (SHAC) block and (SSNB-ANB) block in people with Arthroscopic Rotator Cuff Repair, run by Zagazig University at 1 site in Egypt.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Shoulder pain is frequently encountered in the medical field. Rotator cuff tears are the most common cause. Shoulder pain affects quality of life and delay rehabilitation programs. Effective control of post operative pain is a cornerstone in the success of these surgeries. Read more about this study

Who is it for?
Ages 21 to 65 years
Conditions the study is for
Arthroscopic Rotator Cuff Repair
What is being tested?
(SHAC) block and (SSNB-ANB) block
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteEgypt
Study dates
1 Jun 2025to 30 Jan 2026
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

  • Patients acceptance
  • Age: 21-60 years
  • Sex: both sexes (males or females).
  • Physical status: ASA 1\& II.
  • Body mass index (BMI) ≤ 30 kg/m2
  • Type of operation: arthroscopic rotator cuff repair surgery.
  • Duration of surgery: within 2 hours.

Who cannot join

  • Patient with any contraindications of regional blocks (as coagulopathy or local infection at injection site)
  • Patients with known history of allergy to the study drugs.
  • patients with neuropathy involving the limb undergoing surgery
  • Advanced hepatic, renal, cardiovascular, and neurologic diseases.
  • history of previous shoulder operation or fracture.
  • conversion to open surgery from arthroscopy.
  • pregnant females
  • patients with chronic opioid use

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sherif M. S. Mowafy, MD contact

+201003523374

sherifmowafy2012@gmail.com

Egypt1 site, 1 recruiting
  • Zagazig University Hospitals

    Zagazig, Al Sharqia, 44519

    Sherif M. S. Mowafy, MD, +201003523374, sherifmowafy2012@gmail.com

    Shereen E. Abd Ellatif, MD, +201007948840, shosh.again@gmail.com

    Recruiting

Other trials in Egypt

About this study

Official title: Shoulder Anterior Capsular Block Versus Combined Suprascapular and Axillary Nerve Blocks for Postoperative Analgesia in Arthroscopic Rotator Cuff Repair Surgery

Shoulder pain is frequently encountered in the medical field. Rotator cuff tears are the most common cause. Shoulder pain affects quality of life and delay rehabilitation programs.

Effective control of post operative pain is a cornerstone in the success of these surgeries. Regional anaesthesia is often favoured for shoulder surgery as it could effectively provide anaesthesia and postoperative analgesia. Additionally, the upper limb has multiple nerve targets that can be blocked. Ultrasound combined SSNB-ANB were described as an alternative to interscalene nerve block for shoulder surgeries equipotent pain relief and patient satisfaction as well as fewer complications due to the location of injection.

Ultrasound guided SHAC block is a motor sparing block which targets all nerves supplying shoulder consistently at two sites. It was validated in chronic shoulder pain patients. However, there is no sufficient evidence for this block in postoperative pain after shoulder surgery.

Read the detailed description

Regional anaesthesia is often favoured for shoulder surgery as it could effectively provide anaesthesia and postoperative analgesia. Additionally, the upper limb has multiple nerve targets that can be blocked. Innervation of shoulder joint is complex with 70 % contribution from suprascapular nerve (SSN), remaining from axillary (AN), lateral pectoral, subscapular, and musculocutaneous nerves. Therefore, Effective postoperative analgesia for shoulder surgery should target mainly both the SSN and AN which can be performed either at the level of the nerves themselves or their more proximal origins, often within the brachial plexus.

Until recently, interscalene brachial plexus block (ISB) was considered the gold standard technique for intra- and postoperative pain management in shoulder surgeries. However, its safety was questioned due to its drawbacks including prolonged motor block, and most importantly hemidiaphragm paralysis and the resultant pulmonary function compromise with prolongation of the patients' recovery time. The shoulder block which refers to the combined suprascapular nerve and axillary nerve block (SSNB-ANB) was first described in 2007 as an alternative to interscalene block (ISB) for shoulder surgeries with several studies reporting equipotent pain relief and patient satisfaction when the combined SSNB -ANB compared with the ISB alone with fewer complications due to the location of injection.

In 2020, Galluccio et al. described a novel ultrasound-guided block, the shoulder anterior capsular block (SHAC), motor sparing block, which blocks all the nerves supplying the shoulder based on the combination of two blocks targeting the interfacial and pericapsular spaces. Thanks to this approach which block axillary, subscapular, lateral pectoral and musculocutaneous nerves and avoid motor block associated with more proximal nerve blocks, thus allowing early active mobilization, physiotherapy and rehabilitation.

SHAC block was validated in chronic shoulder pain patients. hence, we hypothesized that SHAC block is effective in postoperative shoulder pain relief and early rehabilitation after ARCR which could make it an alternative to SSNB-ANB in these patients. This study will be undertaken to compare between the analgesic effect of ultrasound guided SHAC block versus combined ultrasound guided SSNB-ANB for arthroscopic rotator cuff surgery.

Being tested
(SHAC) block, (SSNB-ANB) block
Keywords
shoulder anterior capsular block, combined suprascapular and axillary nerve blocks, postoperative analgesia, arthroscopic rotator cuff repair surgery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • (SHAC) blockProcedure or surgery

    The shoulder anterior capsular block targets interfacial and pericapsular space. A 25-gauge 80-mm insulated stimulating needle will be used for injections and in-plane needling will be from lateral to medial side. After aspiration is negative, 10 ml of 0.5 % bupivacaine plus dexamethasone 4 mg as adjuvant will be injected in the interfacial plane. Once the injection into the fascial space is achieved, the operator can proceed towards the glenohumeral pericapsular space by crossing the subscapularis muscle with the needle and the second injection after negative aspiration will be 10 ml 0.5 % bupivacaine plus dexamethasone 4 mg in pericapsular space.

  • (SSNB-ANB) blockProcedure or surgery

    Suprascapular Nerve Block (SNB): Using an in-plane ultrasound guidance from the medial side, 10 mL of 0.5% bupivacaine plus dexamethasone 4 mg as adjuvant will be injected after contacting the lateral aspect of the supraspinous fossa and negative aspiration confirmed. The LA should spread beneath the supraspinatus, lifting up the muscle.

    Axillary Nerve Block (ANB):

    The ANB is performed from behind the patient with the patient seated. The axillary nerve will be identified within the quadrilateral space by placing high frequency linear probe (Sono site M turbo) parallel to the long axis of the humeral shaft. The nerve was identified next to the circumflex artery. The skin will be anesthetized with 1% lidocaine (3mL). 10 mL of 0.5% bupivacaine plus dexamethasone 4 mg will be injected against the surface of the humerus, just posterior and lateral to the artery after confirming negative aspiration.

Study groups in NCT06969625
Study groupRoleWhat they receive
Group (SHAC) blockExperimentalNot described
Receives: Procedure: (SHAC) block
Group (SSNB-ANB) blockActive comparatorNot described
Receives: Procedure: (SSNB-ANB) block

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The total postoperative pethidine consumption (in milligrams) during the first 24-h after surgery.

    Measured: 24 hours after surgery

Secondary outcomes (6)
  1. Postoperative pain assessment by Numeric rating scale (NRS) at rest and on passive movements in the recovery room and at 2,4,8,16 and 24 hours after surgery.

    The patients will be instructed to use numeric rating scale (NRS) for pain. The numeric rating scale will be explained using a 0-10 scale, with the left-most end (zero) meaning "no pain" and the right-most end (10) meaning "the worst pain imaginable". Patients will be instructed to circle the number that represents the amount of pain that they are experiencing at the time of the evaluation

    Measured: 24 hours after surgery

  2. The time to first request of rescue analgesia (pethidine).

    Measured: 24 hours after surgery

  3. 3. The total number of patients requiring additional dose of intraoperative fentanyl.

    Measured: 3 hours

  4. The block performance time

    defined by the sum of scanning time and needle time. Scanning time is the time from ultrasound probe is placed on the skin until a satisfactory image is obtained. Needle time is taken from the time needle tip penetrated the skin and exited after block placement.

    Measured: 1 hour

  5. Over all patients' satisfaction on the next day of surgery

    by using a 5-points likert-like verbal scale (1 = very dissatisfied analgesia, 2 = dissatisfied analgesia, and 3 = neutral, 4=satisfied analgesia, and 5=very satisfied analgesia).

    Measured: 24 hours after surgery

  6. The incidence of any complications

    block related complications including hematoma, local anesthetic toxicity, infection, persistent paresthesia, weakness, and tingling at 1 and 7 days after surgery - opioid related side effects including nausea, vomiting, and sedation).

    Measured: 7 days after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 May 2025
  2. Study start1 Jun 2025 (estimated)
  3. Primary completion1 Jan 2026 (estimated)
  4. Study completion30 Jan 2026 (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
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06969625
Sponsor's protocol ID
1271/27-4-2025
Status last verified
May 2025
First submitted
3 May 2025
Last updated
14 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: all collected IPD

Publications

  • Downie WW, Leatham PA, Rhind VM, Wright V, Branco JA, Anderson JA. Studies with pain rating scales. Ann Rheum Dis. 1978 Aug;37(4):378-81. doi: 10.1136/ard.37.4.378.

    PubMed 686873
  • Galluccio F, Fajardo Perez M, Yamak Altinpulluk E, Hou JD, Lin JA. Evaluation of Interfascial Plane and Pericapsular Nerve Blocks to the Shoulder Joint: A Preliminary Analysis of Shoulder Anterior Capsular Block. Pain Ther. 2021 Dec;10(2):1741-1754. doi: 10.1007/s40122-021-00326-0. Epub 2021 Oct 20.

    PubMed 34669181
  • Galluccio F, Arnay EG, Salazar C, Altinpulluk EY, Capassoni M, Garcia DS, Espinoza K, Olea MS, Perez MF. Re: "Ultrasound-Guided Block of the Axillary Nerve: A Prospective, Randomized, Single-Blind Study Comparing Interfascial and Perivascular Injections". Pain Physician. 2020 Jan;23(1):E62-E64. No abstract available.

    PubMed 32013290
  • Zhao J, Xu N, Li J, Liang G, Zeng L, Luo M, Pan J, Yang W, Liu J. Efficacy and safety of suprascapular nerve block combined with axillary nerve block for arthroscopic shoulder surgery: A systematic review and meta-analysis of randomized controlled trials. Int J Surg. 2021 Oct;94:106111. doi: 10.1016/j.ijsu.2021.106111. Epub 2021 Sep 11.

    PubMed 34520842
  • Faiz SHR, Mohseni M, Imani F, Attaee MK, Movassaghi S, Rahimzadeh P. Comparison of Ultrasound-Guided Supra-scapular Plus Axillary Nerve Block with Interscalene Block for Postoperative Pain Management in Arthroscopic Shoulder Surgery; A Double-Blinded Randomized Open-Label Clinical Trial. Anesth Pain Med. 2021 May 2;11(2):e112540. doi: 10.5812/aapm.112540. eCollection 2021 Apr.

    PubMed 34336619
  • Price DJ. The shoulder block: a new alternative to interscalene brachial plexus blockade for the control of postoperative shoulder pain. Anaesth Intensive Care. 2007 Aug;35(4):575-81. doi: 10.1177/0310057X0703500418.

    PubMed 18020078
  • Divella M, Vetrugno L, Orso D, Langiano N, Bignami E, Bove T, Della Rocca G. Interscalenic versus suprascapular nerve block: can the type of block influence short- and long-term outcomes? An observational study. Minerva Anestesiol. 2019 Apr;85(4):344-350. doi: 10.23736/S0375-9393.18.12791-X. Epub 2018 Jul 9.

    PubMed 29991222
  • Brull R, McCartney CJ, Chan VW, El-Beheiry H. Neurological complications after regional anesthesia: contemporary estimates of risk. Anesth Analg. 2007 Apr;104(4):965-74. doi: 10.1213/01.ane.0000258740.17193.ec.

    PubMed 17377115
  • Lim YC, Koo ZK, Ho VW, Chang SS, Manohara S, Tong QJ. Randomized, controlled trial comparing respiratory and analgesic effects of interscalene, anterior suprascapular, and posterior suprascapular nerve blocks for arthroscopic shoulder surgery. Korean J Anesthesiol. 2020 Oct;73(5):408-416. doi: 10.4097/kja.20141. Epub 2020 Jul 16.

    PubMed 32668833
  • Rhyner P, Kirkham K, Hirotsu C, Farron A, Albrecht E. A randomised controlled trial of shoulder block vs. interscalene brachial plexus block for ventilatory function after shoulder arthroscopy. Anaesthesia. 2020 Apr;75(4):493-498. doi: 10.1111/anae.14957. Epub 2019 Dec 19.

    PubMed 31854463
  • Morita S, Oizumi N, Suenaga N, Yoshioka C, Yamane S, Tanaka Y. Dexamethasone added to levobupivacaine prolongs the duration of interscalene brachial plexus block and decreases rebound pain after arthroscopic rotator cuff repair. J Shoulder Elbow Surg. 2020 Sep;29(9):1751-1757. doi: 10.1016/j.jse.2020.04.019. Epub 2020 Jun 9.

    PubMed 32815804
  • Shishido H, Kikuchi S, Heckman H, Myers RR. Dexamethasone decreases blood flow in normal nerves and dorsal root ganglia. Spine (Phila Pa 1976). 2002 Mar 15;27(6):581-6. doi: 10.1097/00007632-200203150-00005.

    PubMed 11884905
  • 4. Vaidiyanathan B, Sundaresan S, Raajesh I. "Shoulder Anterior Capsular Block: An Effective Strategy for Alleviating Pain During Shoulder Mobilisation in Adhesive Capsulitis Patients": A Case Series. Arch Anesth & Crit Care. 2024;10(Supp. 1):526-29.

  • Borgeat A, Ekatodramis G. Anaesthesia for shoulder surgery. Best Pract Res Clin Anaesthesiol. 2002 Jun;16(2):211-25. doi: 10.1053/bean.2002.0234.

    PubMed 12491553
  • Patel MS, Abboud JA, Sethi PM. Perioperative pain management for shoulder surgery: evolving techniques. J Shoulder Elbow Surg. 2020 Nov;29(11):e416-e433. doi: 10.1016/j.jse.2020.04.049. Epub 2020 Jun 9.

    PubMed 32844751

Questions about this trial

What is this clinical trial studying?

A study testing (SHAC) block and (SSNB-ANB) block in people with Arthroscopic Rotator Cuff Repair, run by Zagazig 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 7 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 14 May 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 Sherif M. S. Mowafy, MD (+201003523374, sherifmowafy2012@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The total postoperative pethidine consumption (in milligrams) during the first 24-h after surgery. (time frame: 24 hours after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06969625, which also lists 16 linked publications.

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 14 May 2025.

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