[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653771":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":13,"studyPopulation":13,"armGroups":24,"interventions":37,"overallOfficials":13,"centralContacts":47,"locations":58,"responsibleParty":74,"collaborators":13,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":13,"eligibilityCriteria":82,"healthyVolunteers":78,"sex":83,"minAge":84,"maxAge":13,"enrollmentInfo":85,"targetDuration":13,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":13,"overallStatus":94,"whyStopped":13,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"King Hussein Cancer Center","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Overall Postoperative Pain Burden During the First 24 Hours After Surgery","Area under the curve (AUC) of Visual Analogue Scale (VAS) pain scores at rest during the first 24 hours after surgery. The Visual Analogue Scale (VAS) ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain; higher scores indicate worse pain.","From the end of surgery through 24 hours postoperatively.",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":13,"primaryPurpose":17,"observationalModel":13,"timePerspective":13,"maskingInfo":18},"RANDOMIZED","PARALLEL","SUPPORTIVE_CARE",{"masking":19,"maskingDescription":13,"whoMasked":20},"TRIPLE",[21,22,23],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR",[25,31],{"label":26,"type":27,"description":28,"interventionNames":29},"Magnesium Sulfate + Bupivacaine","EXPERIMENTAL","Participants will receive a single intraoperative local wound infiltration following modified radical mastectomy with axillary clearance, consisting of 750 mg magnesium sulfate combined with 0.5% bupivacaine. The planned bupivacaine dose is 100 mg (20 mL), subject to reduction if it exceeds the participant-specific maximum allowable dose based on body weight.",[30],"Drug: Magnesium Sulfate 750 mg with Bupivacaine 0.5% for Local Wound Infiltration",{"label":32,"type":33,"description":34,"interventionNames":35},"Bupivacaine + Normal Saline","ACTIVE_COMPARATOR","Participants will receive a single intraoperative local wound infiltration following modified radical mastectomy with axillary clearance, consisting of 0.5% bupivacaine combined with normal saline. The planned bupivacaine dose is 100 mg (20 mL), subject to reduction if it exceeds the participant-specific maximum allowable dose based on body weight.",[36],"Drug: Bupivacaine 0.5% + Normal Saline",[38,43],{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":13},"DRUG","Magnesium Sulfate 750 mg with Bupivacaine 0.5% for Local Wound Infiltration","Magnesium sulfate 750 mg added to 0.5% bupivacaine for a single intraoperative local wound infiltration following modified radical mastectomy with axillary clearance.",[26],{"type":39,"name":44,"description":45,"armGroupLabels":46,"otherNames":13},"Bupivacaine 0.5% + Normal Saline","A single intraoperative local wound infiltration of 0.5% bupivacaine combined with normal saline following modified radical mastectomy with axillary clearance. The planned bupivacaine dose is 100 mg (20 mL), subject to reduction if it exceeds the participant-specific maximum allowable dose based on body weight.",[32],[48,54],{"name":49,"role":50,"phone":51,"phoneExt":52,"email":53},"Supervisor, Clinical Trials Unit","CONTACT","+962 6 5300460","1342","FZahran@KHCC.JO",{"name":55,"role":50,"phone":56,"phoneExt":13,"email":57},"Clinical Research Coordinator","+962 788390734","aa.18586@KHCC.JO",[59],{"facility":60,"status":13,"city":61,"state":13,"zip":13,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"King Hussien Cancer Centre","Amman","Jordan","JO",{"type":65,"coordinates":66},"Point",[67,68],35.94503,31.95522,{"lat":68,"lon":67},[71,72],{"name":49,"role":50,"phone":51,"phoneExt":52,"email":53},{"name":73,"role":50,"phone":56,"phoneExt":52,"email":57},"Clinical Research Coordinator, 0.22",{"type":75,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR","100653771","a-double-blind-randomized-controlled-trial-evaluating-the-analgesic-efficacy-of-magnesium-sulfate-as-an-adjuvant-to-bupivacaine-in-local-wound-infiltration-for-patients-undergoing-modified-radical-mastectomy-mrm-with-axillary-clearance-100653771",false,"NCT07789600","Trial Evaluating the Analgesic Efficacy of Magnesium Sulfate as an Adjuvant to Bupivacaine in Local Wound Infiltration for Patients Undergoing Modified Radical Mastectomy (MRM) With Axillary Clearance","A Double-Blind, Randomized Controlled Trial Evaluating the Analgesic Efficacy of Magnesium Sulfate as an Adjuvant to Bupivacaine in Local Wound Infiltration for Patients Undergoing Modified Radical Mastectomy (MRM) With Axillary Clearance","Inclusion Criteria:\n\n* Adult female patients (age ≥18 years) undergoing elective modified radical mastectomy (MRM) with axillary clearance.\n* ASA physical status I-III.\n* Willingness to participate and provide informed consent.\n\nExclusion Criteria:\n\n* Allergy to bupivacaine or magnesium.\n* Chronic opioid use or pre-existing chronic pain conditions.\n* Significant renal or hepatic impairment.\n* Pregnancy or lactation.\n* Neuromuscular disorders.\n* Abnormal baseline serum magnesium levels (e.g., hypermagnesemia).","ALL","18 Years",{"count":86,"type":87},70,"ESTIMATED","INTERVENTIONAL",[90],"NA","This is a double-blind, randomized, controlled clinical trial evaluating the analgesic efficacy and safety of magnesium sulfate as an adjuvant to bupivacaine for local wound infiltration in patients undergoing modified radical mastectomy with axillary clearance. Participants will be randomized to receive either magnesium sulfate 750 mg with bupivacaine or the control intervention. Postoperative pain, analgesic requirements, and safety outcomes will be assessed during the postoperative period, including a follow-up safety assessment between Day 7 and Day 14 after surgery.",[93],"Modified Radical Mastectomy","NOT_YET_RECRUITING","2026-08-27",{"date":97,"type":98},"2026-08-31","ACTUAL",{"date":100,"type":87},"2026-09-01",{"date":102,"type":87},"2028-03-01",{"name":5,"class":6},1]