[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609610":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":46,"centralContacts":51,"locations":56,"responsibleParty":73,"collaborators":75,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":28,"eligibilityCriteria":84,"healthyVolunteers":80,"sex":85,"minAge":86,"maxAge":28,"enrollmentInfo":87,"targetDuration":28,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":97,"overallStatus":59,"whyStopped":28,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"University of North Carolina, Chapel Hill","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 1: Standard Interscalene Block","ACTIVE_COMPARATOR","Standard Interscalene Brachial Plexus Block (Control)\n\nDescription:\n\nParticipants receive a single 16 mL interscalene block at the C5-C6 level under ultrasound guidance. The injectate contains 15 mL of 0.5% bupivacaine HCl (75 mg) mixed with 1 mL preservative-free dexamethasone (4 mg).",[13,14,15],"Procedure: Ultrasound-Guided Interscalene Brachial Plexus Block","Drug: Bupivacaine HCl 0.5% Injectable Solution","Drug: Dexamethasone 4mg",{"label":17,"type":18,"description":19,"interventionNames":20},"Arm 2: Phrenic-Sparing Block Combination","EXPERIMENTAL","Combined Infraclavicular + Distal Suprascapular Block (Phrenic-Sparing Technique)\n\nDescription:\n\nParticipants receive two ultrasound-guided peripheral nerve blocks designed to minimize phrenic nerve involvement:\n\nInfraclavicular block: 15 mL 0.5% bupivacaine + 1 mL dexamethasone (total 16 mL) Distal suprascapular block: 12 mL 0.5% bupivacaine + 1 mL dexamethasone (total 13 mL) Total local-anesthetic dose = 135 mg bupivacaine + 8 mg dexamethasone, within accepted safety limits.",[21,14,15],"Procedure: Phrenic-Sparing Block Combination (Experimental)",[23,29,33,40],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"PROCEDURE","Ultrasound-Guided Interscalene Brachial Plexus Block","Single 16 mL injection (15 mL 0.5 % bupivacaine + 1 mL dexamethasone 4 mg) at the C5-C6 root level under ultrasound guidance.\n\nPerformed pre-operatively as standard care for shoulder surgery. Arm Cross-Reference: Standard Interscalene Block (Control)",[9],null,{"type":24,"name":30,"description":31,"armGroupLabels":32,"otherNames":28},"Phrenic-Sparing Block Combination (Experimental)","Infraclavicular: 15 mL (75 mg) 0.5 % bupivacaine + 1 mL dexamethasone (4 mg) injected around the cords of the brachial plexus beneath the clavicle under ultrasound guidance.\n\nDistal Suprascapular: 12 mL (60 mg) 0.5 % bupivacaine + 1 mL (4 mg) dexamethasone injected at the suprascapular notch under ultrasound guidance to provide complete shoulder coverage while minimizing phrenic nerve involvement. Total local anesthetic dose = 135 mg bupivacaine + 8 mg dexamethasone.\n\nArm Cross-Reference: Phrenic-Sparing Block Combination (Experimental)",[17],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"DRUG","Bupivacaine HCl 0.5% Injectable Solution","Infraclavicular: Adminstered as 15 mL (75 mg) injection (together with dexamethasone).\n\nDistal Suprascapular: Adminstered as 12 mL (60 mg) injection (together with dexamethasone).",[9,17],[39],"Bupivacaine Hydrochloride Injection",{"type":34,"name":41,"description":42,"armGroupLabels":43,"otherNames":44},"Dexamethasone 4mg","Adminstered as applicable for infraclavicular and distal suprascapular: as 1 mL (4 mg) injection (together with bupicacaine 0.5%).",[9,17],[45],"Decadron, Dexamethasone Intensol, De-Sone LA, Dxevo, Dexacorten",[47],{"name":48,"affiliation":49,"role":50},"Monika Nanda","University of North Carollina at Chapel Hill","PRINCIPAL_INVESTIGATOR",[52],{"name":48,"role":53,"phone":54,"phoneExt":28,"email":55},"CONTACT","919-966-5136","mnanda@aims.unc.edu",[57],{"facility":58,"status":59,"city":60,"state":61,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":71},"University of North Carolina Hospitals","RECRUITING","Chapel Hill","North Carolina","27599","United States","US",{"type":66,"coordinates":67},"Point",[68,69],-79.05584,35.9132,{"lat":69,"lon":68},[72],{"name":48,"role":53,"phone":54,"phoneExt":28,"email":55},{"type":74,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR",[76],{"name":77,"class":6},"American Society of Regional Anesthesia","100609610","interscalene-vs-phrenic-sparing-blocks-in-obesity-and-effect-of-maximum-inspiratory-pressure-100609610",false,"NCT07216820","Interscalene vs Phrenic-sparing Blocks in Obesity and Effect of Maximum Inspiratory Pressure","Interscalene vs Phrenic-sparing Blocks in Obesity: Effect of Pre-operative Maximum Inspiratory Pressure in a Randomized Trial","Inclusion Criteria:\n\n* Age ≥ 18 years (self-report, confirmed on chart).\n* Body-mass index ≥ 35 kg m\\^2 at the pre-operative clinic visit (chart).\n* Scheduled for elective unilateral shoulder surgery (arthroscopy, arthroplasty, rotator cuff repair, reverse arthroplasty) under general anesthesia at UNC Hospitals\n* Planned use of a single-injection regional brachial-plexus block for postoperative analgesia (anesthesia record).\n* Able to perform a maximal-inspiratory-pressure (MIP) maneuver at screening, producing two reproducible efforts (bedside test)\n* Able to read or understand English and provide written informed consent (consent discussion).\n\nExclusion Criteria:\n\n* Emergent or trauma shoulder procedure or case converted to open surgery (schedule\u002Fchart).\n* Pregnancy confirmed by point-of-care urine test on day of surgery (POC test). Prisoner status or legal incapacity to consent (chart\u002Finterview).\n* Severe pulmonary disease: GOLD stage 3-4 COPD, restrictive lung disease unrelated to obesity with FVC \\\u003C 50 % predicted, baseline dyspnea Borg ≥ 3, or home oxygen therapy (pulmonary clinic notes, patient interview).\n* Severe heart disease- Severe valvular heart disease, Congestive Heart Failure NYHA Class III or IV, Obstructive Coronary Artery Disease with Angina\n* Neuromuscular disorders affecting respiratory muscles (e.g., ALS, myasthenia gravis) or known diaphragmatic paralysis (chart).\n* Coagulopathy (platelets \\\u003C 100 × 10\u002F L or INR \\> 1.5) or local infection at block sites (pre-op labs\u002Fassessment).\n* Anemia and hemoglobinopathies: Hgb \\\u003C10 g\u002Fdl, clinically significant hemoglobinopathy.\n* Allergy to bupivacaine, dexamethasone, or ultrasound gel (self-report).\n* Chronic opioid use \\> 100 mg oral-morphine equivalents per day in the three months preceding surgery (medication history, PDMP query).\n* Prior enrolment in this trial or planned participation in another interventional study that might confound outcomes (research registry).\n* Anticipated inability to comply with postoperative assessments (e.g., profound cognitive impairment, expected early transfer to outside facility) as judged by the investigator","ALL","18 Years",{"count":88,"type":89},68,"ESTIMATED","INTERVENTIONAL",[92],"NA","The goal of this clinical trial is to learn whether a phrenic-sparing nerve block can lower early breathing problems after shoulder surgery in adults with obesity, and whether a simple breathing-strength test (maximum inspiratory pressure, MIP) helps identify who is at higher risk. The main questions are:\n\nDoes the phrenic-sparing approach reduce breathlessness or oxygen need in the recovery room (30-60 minutes after arrival)? Do patients have similar pain control and opioid use compared with the standard interscalene block (ISB)? Are there any breathing-related complications or unplanned admissions within 24 hours? Researchers will compare the phrenic-sparing block (infraclavicular + distal suprascapular) to the standard ISB, both commonly used at UNC.\n\nParticipants will:\n\nHave a quick MIP breath test before surgery (and, if age ≥65, a brief thigh muscle ultrasound).\n\nBe randomly assigned to receive either the standard ISB or the phrenic-sparing block (both ultrasound-guided and part of routine care).\n\nReceive usual anesthesia\u002Fsurgery; have a brief recovery check at 30-60 minutes (breathlessness score, oxygen use, oxygen level).\n\nHave pain medicines recorded from anesthesia start to PACU discharge; the team may review the chart up to 24 hours and make a short follow-up call (24-48 hours).",[95,96],"Shoulder Surgery","Obesity",[98,99,100],"interscalene block","phrenic-sparing block","brachial plexus block","2026-01-27",{"date":103,"type":104},"2026-01-28","ACTUAL",{"date":106,"type":104},"2026-01-21",{"date":108,"type":89},"2027-11-15",{"name":5,"class":6},1]