Shoulder surgery performed in the outpatient setting can be associated with moderate to severe postoperative pain, especially during the first hours after surgery. Regional anesthesia is commonly used to improve postoperative pain control, reduce opioid use, and support early recovery and safe discharge.
The interscalene block (ISB) is widely considered an effective regional anesthesia technique for shoulder surgery, but it may be associated with adverse effects such as diaphragmatic impairment, dyspnea, hoarseness, Horner syndrome, and prolonged upper limb motor block. The anterior suprascapular nerve block (SSNB-A) is a more selective regional anesthesia technique that may provide comparable postoperative analgesia with fewer block-related adverse effects.
This prospective, randomized, single-blind, noninferiority trial compares SSNB-A with ISB in adult patients undergoing unilateral shoulder surgery in the outpatient setting. All participants receive general anesthesia and the same multimodal analgesic strategy. The primary objective is to determine whether SSNB-A is noninferior to ISB for postoperative pain control, assessed using the Numeric Rating Scale (NRS). Secondary outcomes include quality of recovery measured with the QoR-15 questionnaire, block-related adverse events, sensory and motor block characteristics, and the need for rescue analgesic medication.
Age > 18 years.
ASA physical status I, II, or III.
Scheduled for unilateral shoulder orthopedic surgery in the outpatient/day surgery setting under general anesthesia.
Surgical procedures may include long head of biceps tenotomy, biceps anchor repair, Bankart procedure, rotator cuff repair with or without biological membrane augmentation, subacromial decompression, acromioplasty, or acromioclavicular stabilization.
Contraindication to regional anesthesia, including allergy to local anesthetics, infection at the injection site, bleeding diathesis, or other contraindications according to applicable clinical practice recommendations.
Allergy to paracetamol or to any drug used in the multimodal rescue analgesic strategy.
Known neuropathy or sensory/motor deficit in the surgical area or in the territory of innervation of the study blocks.
History of psychiatric or behavioral disorders that may interfere with study participation or outcome assessment.
Parallel
Interscalene Nerve Block
Procedure/SurgeryParticipants receive an ultrasound-guided interscalene brachial plexus block before shoulder surgery using 10 mL of ropivacaina 0,5%, followed bu standardized general anesthesia and postoperative multimodal analgesia
Anterior suprascapular nerve block
Procedure/SurgeryParticipants receive an ultrasound-guided anterior suprascapular nerve block before shoulder surgery using 10 mL of ropivacaine 0,5%, followed by standardized general anesthesia and postoperative multimodal analgesia.
Ropivacaine
DrugRopivacaine 0.5% is used as the local anesthetic for the assigned ultrasound-guided regional anesthesia procedure. Participants receive 10 mL of ropivacaine 0.5% either for interscalene brachial plexus block or for anterior suprascapular nerve block, according to randomized group allocation. The same drug concentration and volume are used in both study groups.
Postoperative pain intensity at 6 hours after surgery
Postoperative pain intensity assessed using the Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst imaginable pain. The primary analysis compares NRS pain scores between the anterior suprascapular nerve block group and the interscalene block group to assess noninferiority.
Postoperative Pain Intensity at Other Predefined Postoperative Time Points
Postoperative pain intensity assessed using the Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst imaginable pain, at predefined postoperative time points other than the primary 6-hour endpoint
Quality of Recovery
Quality of recovery assessed using the 15-item Quality of Recovery questionnaire (QoR-15). The QoR-15 is a patient-reported outcome measure evaluating postoperative recovery across multiple domains, including pain, physical comfort, physical independence, psychological support, and emotional state. Higher scores indicate better quality of recovery. Scores will be compared between the two study groups at predefined postoperative time points.
Incidence of Block-Related Adverse Events
Incidence of adverse events potentially related to the regional anesthesia technique, including dyspnea, oxygen desaturation, hoarseness, Horner syndrome, pneumothorax, and neurologic complications. The incidence of these events will be compared between the anterior suprascapular nerve block group and the interscalene block group.
Rescue Analgesic Consumption
Use of rescue analgesic medication for uncontrolled postoperative pain within the standardized multimodal analgesic protocol. During the postoperative hospital stay, first-line rescue analgesia consists of nonsteroidal anti-inflammatory drugs and second-line rescue analgesia consists of opioid analgesics. After discharge, rescue analgesic use includes dexibuprofen 400 mg as first-line rescue medication and tapentadol 50 mg as second-line rescue medication. For each rescue analgesic administration or intake, the timing and the NRS pain score at the time of use will be recorded. Rescue analgesic consumption will be compared between the anterior suprascapular nerve block group and the interscalene block group.
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ASST Sette Laghi
Lead sponsor
Ospedale di Circolo - Fondazione Macchi
Sponsor institution
