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

NCT ID: NCT06969625

Last Updated: 2025-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-01

Study Completion Date

2026-01-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Arthroscopic Rotator Cuff Repair

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Group (SHAC) block

Group Type EXPERIMENTAL

(SHAC) block

Intervention Type PROCEDURE

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.

Group (SSNB-ANB) block

Group Type ACTIVE_COMPARATOR

(SSNB-ANB) block

Intervention Type PROCEDURE

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.

Interventions

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(SHAC) block

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.

Intervention Type PROCEDURE

(SSNB-ANB) block

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zagazig University

OTHER_GOV

Sponsor Role lead

Responsible Party

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Sherif M. S. Mowafy

Associate professor of anaesthesia, intensive care, and pain management

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shereen E. Abd Ellatif, MD

Role: STUDY_DIRECTOR

Anaesthesia, Intensive Care, and Pain Management Department. Faculty of Medicine, Zagazig University

Sherif M. S. Mowafy, MD

Role: PRINCIPAL_INVESTIGATOR

Anaesthesia, Intensive Care, and Pain Management Department. Faculty of Medicine, Zagazig University

Fatma M. Ahmed, MD

Role: STUDY_CHAIR

Anaesthesia, Intensive Care, and Pain Management Department. Faculty of Medicine, Zagazig University

Locations

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Zagazig University Hospitals

Zagazig, Al Sharqia, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Sherif M. S. Mowafy, MD

Role: CONTACT

+201003523374

Facility Contacts

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Sherif M. S. Mowafy, MD

Role: primary

+201003523374

Shereen E. Abd Ellatif, MD

Role: backup

+201007948840

References

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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.

Reference Type BACKGROUND
PMID: 686873 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34669181 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32013290 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34520842 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34336619 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18020078 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29991222 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17377115 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32668833 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31854463 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32815804 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11884905 (View on PubMed)

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.

Reference Type BACKGROUND

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.

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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.

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Blom AW, Donovan RL, Beswick AD, Whitehouse MR, Kunutsor SK. Common elective orthopaedic procedures and their clinical effectiveness: umbrella review of level 1 evidence. BMJ. 2021 Jul 7;374:n1511. doi: 10.1136/bmj.n1511.

Reference Type BACKGROUND
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Other Identifiers

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1271/27-4-2025

Identifier Type: -

Identifier Source: org_study_id

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