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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура (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 subscapula
• Процедура (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 quadrilater

Первичные конечные точки

• The total postoperative pethidine consumption (in milligrams) during the first 24-h after surgery. [Срок оценки: 24 hours after surgery]

Вторичные конечные точки (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. [Срок оценки: 24 hours after surgery]
• The time to first request of rescue analgesia (pethidine). [Срок оценки: 24 hours after surgery]
• 3. The total number of patients requiring additional dose of intraoperative fentanyl. [Срок оценки: 3 hours]
• The block performance time [Срок оценки: 1 hour]
• Over all patients' satisfaction on the next day of surgery [Срок оценки: 24 hours after surgery]
• The incidence of any complications [Срок оценки: 7 days after surgery]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Zagazig University Hospitals — Zagazig

Публикации

• 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 17377115

Идентификаторы

NCT: NCT06969625 · 1271/27-4-2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗