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

NCT06969625 | Recruiting DMC

• 1 other identifier: 1271/27-4-2025
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Arthroscopic Rotator Cuff Repair

Keywords

shoulder anterior capsular block; combined suprascapular and axillary nerve blocks; postoperative analgesia; arthroscopic rotator cuff repair surgery

Outcome Measures

Primary Outcomes (1)

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

  24 hours after surgery

Secondary Outcomes (6)

• 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.

  24 hours after surgery

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

  24 hours after surgery

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

  3 hours

• The block performance time

  1 hour

• Over all patients' satisfaction on the next day of surgery

  24 hours after surgery

Study Arms (2)

Group (SHAC) block

EXPERIMENTAL

Procedure: (SHAC) block

Group (SSNB-ANB) block

ACTIVE COMPARATOR

Procedure: (SSNB-ANB) block

Interventions

(SHAC) block 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 (SHAC) block

(SSNB-ANB) block 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.

Group (SSNB-ANB) block

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig University Hospitals

Zagazig, Al Sharqia, 44519, Egypt

RECRUITING

Related Publications (16)

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• 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.

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  PMID: 34336619 BACKGROUND

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  PMID: 29991222 BACKGROUND

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  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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MeSH Terms

Interventions

Dental Occlusion

Intervention Hierarchy (Ancestors)

Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Officials

• Shereen E. Abd Ellatif, MD

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

  STUDY DIRECTOR

• Sherif M. S. Mowafy, MD

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

  PRINCIPAL INVESTIGATOR

• Fatma M. Ahmed, MD

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

  STUDY CHAIR

Central Study Contacts

Sherif M. S. Mowafy, MD

CONTACT

+201003523374; sherifmowafy2012@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of anaesthesia, intensive care, and pain management

Study Record Dates

• First Submitted: May 3, 2025
• First Posted: May 14, 2025
• Study Start: June 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 30, 2026
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: starting 6 months after publication
• Access Criteria: from the study director

Locations

EG (1)