Clinical trial NCT06969625: Shoulder Anterior Capsular Block for Postoperative Analgesia in Arthroscopic Rotator Cuff Repair Surgery
Official title: Shoulder Anterior Capsular Block Versus Combined Suprascapular and Axillary Nerve Blocks for Postoperative Analgesia in Arthroscopic Rotator Cuff Repair Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Arthroscopic Rotator Cuff Repair
Keywords: shoulder anterior capsular block
combined suprascapular and axillary nerve blocks
postoperative analgesia
arthroscopic rotator cuff repair surgery
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2025-05-14
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The total postoperative pethidine consumption (in milligrams) during the first 24-h after surgery.
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: 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.
timeFrame: 24 hours after surgery
measure: The time to first request of rescue analgesia (pethidine).
timeFrame: 24 hours after surgery
measure: 3. The total number of patients requiring additional dose of intraoperative fentanyl.
timeFrame: 3 hours
measure: The block performance time
timeFrame: 1 hour
measure: Over all patients' satisfaction on the next day of surgery
timeFrame: 24 hours after surgery
measure: The incidence of any complications
timeFrame: 7 days after surgery
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig University Hospitals
state: Al Sharqia
Study officials:
affiliation: Anaesthesia, Intensive Care, and Pain Management Department. Faculty of Medicine, Zagazig University
name: Shereen E. Abd Ellatif, MD
role: STUDY_DIRECTOR
affiliation: Anaesthesia, Intensive Care, and Pain Management Department. Faculty of Medicine, Zagazig University
name: Sherif M. S. Mowafy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Anaesthesia, Intensive Care, and Pain Management Department. Faculty of Medicine, Zagazig University
name: Fatma M. Ahmed, MD
role: STUDY_CHAIR
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