[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656754":3},{"organization":4,"outcomesModule":7,"designInfo":35,"detailedDescription":46,"studyPopulation":34,"armGroups":47,"interventions":61,"overallOfficials":34,"centralContacts":84,"locations":93,"responsibleParty":119,"collaborators":34,"id":123,"slug":124,"hasResults":125,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":34,"eligibilityCriteria":129,"healthyVolunteers":125,"sex":130,"minAge":131,"maxAge":34,"enrollmentInfo":132,"targetDuration":34,"studyType":135,"phases":136,"briefSummary":138,"conditions":139,"keywords":141,"overallStatus":96,"whyStopped":34,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":158},{"fullName":5,"class":6},"ASST Sette Laghi","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":34},[9],{"measure":10,"description":11,"timeFrame":12},"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.","6 hours after surgery",[14,18,22,26,30],{"measure":15,"description":16,"timeFrame":17},"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","At post-anesthesia care unit arrival and at 12, 18, 24, 36, 48, and 72 hours after surgery",{"measure":19,"description":20,"timeFrame":21},"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.","On postoperative day 0, postoperative day 1, postoperative day 2, postoperative day 3, and postoperative day 5",{"measure":23,"description":24,"timeFrame":25},"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.","From block performance through postoperative day 0",{"measure":27,"description":28,"timeFrame":29},"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.","From post-anesthesia care unit arrival through postoperative day 5",{"measure":31,"description":32,"timeFrame":33},"Sensory and Motor Block Characteristics","Sensory and motor block characteristics assessed after regional anesthesia in the relevant nerve territories. Sensory and motor function will be evaluated in C5, C6, C7, C8, T1, and superior trunk territory using a 3-point scale, where 2 indicates normal sensation or motor function, 1 indicates reduced sensation or motor function, and 0 indicates absent sensation or motor function. The extent, onset, and persistence of sensory and motor block will be compared between the anterior suprascapular nerve block group and the interscalene block group.","At 30 minutes after block performance, at post-anesthesia care unit arrival, and 6 hours after surgery",null,{"allocation":36,"interventionModel":37,"interventionModelDescription":38,"primaryPurpose":39,"observationalModel":34,"timePerspective":34,"maskingInfo":40},"RANDOMIZED","PARALLEL","Participants are randomized in a 1:1 ratioto receive either ultrasound-guided interscalene block or ultrasound-guided anterior suprascapular nerve block before shoulder surgery. The two groups are followed in parallel and receive the same general anesthesia and multimodal postoperative analgesic protocol.","TREATMENT",{"masking":41,"maskingDescription":42,"whoMasked":43},"DOUBLE","Participants and postoperative outcome assessors are blinded to treatment allocation. The anesthesiologist performing the regional anesthesia technique is not blinded because the two blocks require different anatomical approaches. Postoperative data collection is performed by assessors unaware of grous assignment",[44,45],"PARTICIPANT","OUTCOMES_ASSESSOR","Shoulder surgery in the outpatient setting requires an anesthetic and analgesic strategy that provides effective postoperative pain control while allowing early recovery and safe discharge. Unilateral shoulder procedures may be associated with moderate to severe postoperative pain, particularly during the first 24 to 48 hours after surgery. In this context, regional anesthesia is an important component of perioperative pain management because it can reduce postoperative pain, decrease the need for opioid analgesics, limit postoperative nausea and vomiting, and facilitate early rehabilitation and recovery.\n\nThe interscalene brachial plexus block (ISB) is commonly used for postoperative analgesia after shoulder surgery and is considered one of the most effective regional anesthesia techniques for this indication. However, ISB may be associated with block-related adverse effects, including variable phrenic nerve involvement with diaphragmatic impairment, dyspnea, Horner syndrome, hoarseness, and prolonged motor block of the upper limb. These effects may be particularly relevant in the outpatient setting, where delayed discharge, unplanned admission, or reduced quality of recovery may occur if adverse effects persist after surgery.\n\nThe anterior suprascapular nerve block (SSNB-A) has been proposed as a regional anesthesia technique for shoulder surgery that may provide effective analgesia while potentially reducing some of the adverse effects associated with ISB. The suprascapular nerve contributes substantially to the sensory innervation of the shoulder. The anterior approach targets the nerve in the supraclavicular region and may also allow local anesthetic spread toward relevant components of the superior trunk region involved in shoulder innervation. Available evidence suggests that SSNB-A may provide postoperative analgesia comparable to ISB in selected shoulder procedures, with a potentially more favorable side-effect profile.\n\nThis study is a prospective, monocentric, randomized, single-blind, noninferiority trial comparing SSNB-A with ISB for postoperative analgesia in adult patients undergoing unilateral shoulder surgery in the outpatient setting. Participants are randomized to receive either an ultrasound-guided interscalene block or an ultrasound-guided anterior suprascapular nerve block before surgery. Randomization is performed shortly before the procedure using block randomization in order to ensure balanced allocation between the two study groups.\n\nEligible participants are adult patients scheduled for unilateral shoulder surgery in the outpatient 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, and acromioclavicular stabilization. Participants are screened according to predefined inclusion and exclusion criteria. Exclusion criteria include contraindications to regional anesthesia, allergy to local anesthetics or study analgesic drugs, known neuropathy or sensory or motor deficits in the surgical area or block territory, severe obesity, severe chronic obstructive pulmonary disease, pregnancy, known phrenic nerve paralysis with diaphragmatic paralysis, chronic opioid use, severe chronic pain, and inability or unwillingness to follow the postoperative analgesic protocol.\n\nBoth regional anesthesia techniques are routinely used at the study center and are performed by anesthesiologists experienced in ultrasound-guided upper limb nerve blocks. In the ISB group, the block is performed with the patient in the supine or semi-sitting position, with the head turned away from the surgical side. The brachial plexus is identified between the anterior and middle scalene muscles at the level of the cricoid cartilage using a linear ultrasound probe. An echogenic 21-gauge needle is advanced with an in-plane technique toward the space between the C5 and C6 nerve roots. After negative aspiration, 10 mL of ropivacaine 0.5% is injected in divided boluses to obtain adequate local anesthetic spread.\n\nIn the SSNB-A group, the block is performed with the patient in the supine or semi-sitting position, with the head turned away from the surgical side. The superior trunk of the brachial plexus is identified using a linear ultrasound probe, and the suprascapular nerve is visualized in the supraclavicular fossa as it separates from the superior trunk and courses beneath the inferior belly of the omohyoid muscle. An echogenic 21-gauge needle is advanced with an in-plane technique toward the suprascapular nerve. After negative aspiration, 10 mL of ropivacaine 0.5% is injected in divided boluses to obtain adequate spread around the nerve.\n\nAll participants undergo general anesthesia according to the study protocol. Intraoperative monitoring includes oxygen saturation, heart rate, noninvasive blood pressure, 5-lead electrocardiography, bispectral index monitoring, end-tidal carbon dioxide, and body temperature. Dexamethasone 0.15 mg\u002Fkg is administered intravenously before surgical incision. General anesthesia is maintained with inhaled anesthetics and opioids. Before the end of surgery, paracetamol 15 mg\u002Fkg and ondansetron 0.1 mg\u002Fkg are administered according to the protocol. After emergence from anesthesia, participants are observed in the post-anesthesia care unit.\n\nPostoperative analgesia is standardized in both study groups. In the post-anesthesia care unit, if postoperative pain is rated as NRS 4 or higher, ketorolac 30 mg intravenously is administered as first-line rescue analgesia. If pain remains uncontrolled after 30 minutes, tramadol 1 mg\u002Fkg intravenously is administered as second-line rescue analgesia. Participants are discharged from the post-anesthesia care unit to the day surgery ward when Aldrete discharge criteria are met. During the day surgery stay, participants continue the standardized recovery pathway, including monitoring of vital signs, pain control, mobilization, oral intake, hydration, and spontaneous urination. Additional postoperative analgesia during the ward stay includes oral paracetamol and ibuprofen as rescue therapy according to the study protocol.\n\nAt discharge, participants receive instructions for the postoperative multimodal analgesic regimen and the data collection forms. Post-discharge follow-up is performed by telephone at predefined time points in order to assess pain control, adherence to the analgesic regimen, recovery, adverse events, and outcome measures. Quality of recovery is assessed using the QoR-15 questionnaire during follow-up. Postoperative pain is assessed using the Numeric Rating Scale at predefined time points after surgery.\n\nThe primary objective of the study is to determine whether SSNB-A is noninferior to ISB in terms of postoperative pain control after shoulder surgery in the outpatient setting. The primary endpoint is postoperative pain measured by the Numeric Rating Scale, with the main analysis focused on the NRS score at 6 hours after surgery. The noninferiority margin is defined as 1.1 points on the 0-to-10 NRS scale.\n\nSecondary objectives include comparison of block-related adverse events, including dyspnea, oxygen desaturation, hoarseness, Horner syndrome, pneumothorax, and neurologic complications; assessment of quality of recovery using the QoR-15 questionnaire at discharge and during postoperative follow-up up to postoperative day 5 and at 30 days; comparison of sensory and motor block characteristics in the relevant dermatomes and myotomes; and comparison of rescue analgesic use within a standardized multimodal analgesic protocol.\n\nBaseline demographic and clinical data are collected before the anesthetic procedures, including age, sex, weight, height, ASA physical status, previous surgery, allergies, current medications, and relevant medical history. Intraoperative and postoperative data are collected according to the study protocol. Participants and postoperative outcome assessors are blinded to group allocation, while the anesthesiologist performing the block is not blinded. Statistical analyses are planned before completion of data collection and are performed by an investigator blinded to treatment allocation.\n\nThe planned sample size is 100 participants. The sample size calculation is based on the primary noninferiority analysis of postoperative NRS pain scores, assuming a noninferiority margin of 1.1, an estimated standard deviation of 2, a one-sided type I error rate of 5%, and a type II error rate below 20%. The sample size is increased to account for protocol deviations and exclusions, as the primary analysis is planned according to a per-protocol approach.\n\nThe study is conducted in accordance with the principles of Good Clinical Practice, the Declaration of Helsinki, and applicable national and international regulations regarding personal data protection. Written informed consent is obtained from all participants before enrollment.",[48,55],{"label":49,"type":50,"description":51,"interventionNames":52},"Interscalene block","ACTIVE_COMPARATOR","Participants randomized to this group receive an ultrasound-guided interscalene brachial plexus block before shoulder surgery, followed by standardized general anesthesia and the same multimodal postoperative analgesic protocol used in both study groups.",[53,54],"Procedure: Interscalene Nerve Block","Drug: Ropivacaine",{"label":56,"type":57,"description":58,"interventionNames":59},"Anterior Suprascapular Nerve Block","EXPERIMENTAL","Participants randomized to this group receive an ultrasound-guided anterior suprascapular nerve block before shoulder surgery, followed by standardized general anesthesia and the same multimodal postoperative analgesic protocol used in both study groups.",[60,54],"Procedure: Anterior suprascapular nerve block",[62,70,77],{"type":63,"name":64,"description":65,"armGroupLabels":66,"otherNames":67},"PROCEDURE","Interscalene Nerve Block","Participants 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",[49],[68,69],"Ultrasound-guided interscalene block","ISB",{"type":63,"name":71,"description":72,"armGroupLabels":73,"otherNames":74},"Anterior suprascapular nerve block","Participants 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.",[56],[75,76],"SSNB-A","Ultrasound-guided anterior suprascapular nerve block",{"type":78,"name":79,"description":80,"armGroupLabels":81,"otherNames":82},"DRUG","Ropivacaine","Ropivacaine 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.",[56,49],[83],"Ropivacaine 0.5%",[85,90],{"name":86,"role":87,"phone":88,"phoneExt":34,"email":89},"Giorgio Rossoni, MD","CONTACT","0039 0332393447","giorgio.rossoni@asst-settelaghi.it",{"name":91,"role":87,"phone":88,"phoneExt":34,"email":92},"Anna Marcato Anna Marcato, MD","anna.marcato@asst-settelaghi.it",[94],{"facility":95,"status":96,"city":97,"state":98,"zip":99,"country":98,"countryCode":100,"cosmosGeoPoint":101,"geoPoint":106,"contacts":107},"University Hospital Varese ASST SetteLaghi","RECRUITING","Varese","Italy","21100","IT",{"type":102,"coordinates":103},"Point",[104,105],8.82511,45.82058,{"lat":105,"lon":104},[108,109,111,113,115,117],{"name":86,"role":87,"phone":88,"phoneExt":34,"email":89},{"name":110,"role":87,"phone":88,"phoneExt":34,"email":92},"Anna Marcato, MD",{"name":110,"role":112,"phone":34,"phoneExt":34,"email":34},"SUB_INVESTIGATOR",{"name":86,"role":114,"phone":34,"phoneExt":34,"email":34},"PRINCIPAL_INVESTIGATOR",{"name":116,"role":112,"phone":34,"phoneExt":34,"email":34},"Laura Camici, MD",{"name":118,"role":112,"phone":34,"phoneExt":34,"email":34},"Gabriele Selmo, MD",{"type":114,"investigatorFullName":120,"investigatorTitle":121,"investigatorAffiliation":122,"oldNameTitle":34,"oldOrganization":34},"Giorgio Rossoni","MD","Ospedale di Circolo - Fondazione Macchi","100656754","anterior-suprascapular-versus-interscalene-block-for-postoperative-analgesia-after-arthroscopic-shoulder-surgery-in-the-outpatient-setting-100656754",false,"NCT07831096","Anterior Suprascapular Versus Interscalene Block for Postoperative Analgesia After Arthroscopic Shoulder Surgery in the Outpatient Setting","Interscalene Block Versus Anterior Suprascapular Nerve Block for Shoulder Surgery in the Outpatient Setting: Postoperative Pain Managemente and Quality of Recovery With a Multimodal Analgesic Strategy","Inclusion Criteria:\n\n* Age \\> 18 years.\n* ASA physical status I, II, or III.\n* Scheduled for unilateral shoulder orthopedic surgery in the outpatient\u002Fday surgery setting under general anesthesia.\n* 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.\n* Ability to understand the study procedures and provide written informed consent.\n\nExclusion Criteria:\n\n* 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.\n* Allergy to paracetamol or to any drug used in the multimodal rescue analgesic strategy.\n* Known neuropathy or sensory\u002Fmotor deficit in the surgical area or in the territory of innervation of the study blocks.\n* History of psychiatric or behavioral disorders that may interfere with study participation or outcome assessment.\n* Severe obesity, defined as body mass index (BMI) \\> 40 kg\u002Fm2.\n* Severe chronic obstructive pulmonary disease, GOLD stage III-IV.\n* Pregnancy.\n* Known phrenic nerve palsy associated with diaphragmatic paralysis.\n* Chronic opioid use during the previous 3 months.\n* Severe chronic pain during the previous 3 months, defined as NRS \\> 4.\n* Non-adherence to the postoperative analgesic protocol.","ALL","18 Years",{"count":133,"type":134},100,"ESTIMATED","INTERVENTIONAL",[137],"NA","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.\n\nThe 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.\n\nThis 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.",[140],"Postoperative Pain, Acute",[142,49,71,143,144,145,146,147,148],"Shoulder surgery","Regional Anesthesia","Outpatient Surgery","Postoperative analgesia","Quality of recovery","Numeric Rating Scale","Multimodal Analgesia","2026-09-15",{"date":151,"type":152},"2026-09-21","ACTUAL",{"date":154,"type":152},"2026-01-16",{"date":156,"type":134},"2027-04",{"name":5,"class":6},1]