[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635766":3},{"organization":4,"outcomesModule":7,"designInfo":68,"detailedDescription":71,"studyPopulation":71,"armGroups":80,"interventions":93,"overallOfficials":103,"centralContacts":109,"locations":118,"responsibleParty":137,"collaborators":71,"id":140,"slug":71,"hasResults":141,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":71,"eligibilityCriteria":145,"healthyVolunteers":141,"sex":146,"minAge":147,"maxAge":148,"enrollmentInfo":149,"targetDuration":71,"studyType":152,"phases":153,"briefSummary":155,"conditions":156,"keywords":158,"overallStatus":121,"whyStopped":71,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":172},{"fullName":5,"class":6},"McGill University Health Centre\u002FResearch Institute of the McGill University Health Centre","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":59},[9],{"measure":10,"description":11,"timeFrame":12},"Chronic post-mastectomy pain","Brief Pain Inventory score ≥3\u002F10","3 months postoperatively",[14,18,21,23,25,27,29,30,31,32,36,37,38,41,44,47,49,51,53,56],{"measure":15,"description":16,"timeFrame":17},"Acute postoperative pain","Numerical rating scale (ranging from 0: no pain - to 10: the worst possible pain)","within 0-15 minutes after post-anesthesia care unit (PACU) admission",{"measure":19,"description":16,"timeFrame":20},"acute postoperative pain","Within 30 minutes prior to PACU discharge",{"measure":15,"description":16,"timeFrame":22},"on postoperative day 1",{"measure":15,"description":16,"timeFrame":24},"on postoperative day 7",{"measure":15,"description":16,"timeFrame":26},"1 month postoperatively",{"measure":15,"description":28,"timeFrame":20},"postoperative opioids consumption",{"measure":15,"description":28,"timeFrame":22},{"measure":15,"description":28,"timeFrame":24},{"measure":15,"description":28,"timeFrame":26},{"measure":33,"description":34,"timeFrame":35},"postoperative nausea and vomiting","binary question","within 30 minutes prior to PACU discharge",{"measure":33,"description":34,"timeFrame":22},{"measure":33,"description":34,"timeFrame":24},{"measure":39,"description":40,"timeFrame":12},"postoperative complications","anamnesis",{"measure":42,"description":43,"timeFrame":12},"anxiety and depression","Hospital Anxiety and Depression Scale (HADS): It consists of 14 questions, with 7 measuring anxiety (HADS-A) and 7 measuring depression (HADS-D).\n\nScoring: Each question is scored from 0-3, totaling 0-21 per subscale. A score from 0 to 7 is within the typical range, a score between 8 and 10 is a borderline score, and a score \\>10 depicts a moderate to severe anxiety or depression.",{"measure":45,"description":46,"timeFrame":20},"Analgesics consumption","The use of analgesics (acetaminophen, NSAIDS, opioids) and their doses during the PACU stay",{"measure":45,"description":48,"timeFrame":22},"The use of analgesics (acetaminophen, NSAIDS, opioids) and their doses during the first 24h after surgery",{"measure":45,"description":50,"timeFrame":24},"The use of analgesics (acetaminophen, NSAIDS, opioids) and their doses during the week after surgery",{"measure":45,"description":52,"timeFrame":26},"The use of analgesics (acetaminophen, NSAIDS, opioids) and their doses during the month after surgery",{"measure":54,"description":55,"timeFrame":12},"analgesics consumption","The use of analgesics (acetaminophen, NSAIDS, opioids) and their doses during the second and third months after surgery",{"measure":57,"description":58,"timeFrame":12},"Postoperative complications","Any complication in relationship with the surgery occurring during the 3 months after surgery",[60,63,64,67],{"measure":61,"description":62,"timeFrame":26},"Functional recovery","New or worsening cognitive, physical, sleeping disorders occurring during the 3 months after surgery, using binary question",{"measure":61,"description":62,"timeFrame":12},{"measure":65,"description":66,"timeFrame":26},"Health-related quality of life","Health-related quality of life, assessed using a numeric rating scale",{"measure":65,"description":66,"timeFrame":12},{"allocation":69,"interventionModel":70,"interventionModelDescription":71,"primaryPurpose":72,"observationalModel":71,"timePerspective":71,"maskingInfo":73},"RANDOMIZED","PARALLEL",null,"PREVENTION",{"masking":74,"maskingDescription":71,"whoMasked":75},"QUADRUPLE",[76,77,78,79],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[81,87],{"label":82,"type":83,"description":84,"interventionNames":85},"Dexamethasone","EXPERIMENTAL","Participants randomized to the intervention group will receive a single dose of dexamethasone 8 mg administered intravenously at induction of anesthesia. This dose and timing reflect standard clinical practice for patients at risk of postoperative nausea and vomiting.",[86],"Drug: Dexamethasone (intravenous)",{"label":88,"type":89,"description":90,"interventionNames":91},"Placebo","PLACEBO_COMPARATOR","Participants randomized to the control group will receive a placebo, consisting of an equivalent volume of normal saline, administered intravenously at induction of anesthesia.",[92],"Drug: Normal Saline (0.9% NaCl)",[94,99],{"type":95,"name":96,"description":97,"armGroupLabels":98,"otherNames":71},"DRUG","Dexamethasone (intravenous)","The investigational product used in this study is dexamethasone, a corticosteroid routinely administered in the perioperative setting for the prevention of postoperative nausea and vomiting.",[82],{"type":95,"name":100,"description":101,"armGroupLabels":102,"otherNames":71},"Normal Saline (0.9% NaCl)","normal saline at a equivalent volume",[88],[104,107],{"name":105,"affiliation":5,"role":106},"Oana Predescu, MD, PhD, MSc","PRINCIPAL_INVESTIGATOR",{"name":108,"affiliation":5,"role":106},"Thomas Schricker, MD, PhD",[110,115],{"name":105,"role":111,"phone":112,"phoneExt":113,"email":114},"CONTACT","514-934-1934","44604","oana.predescu@mcgill.ca",{"name":116,"role":111,"phone":112,"phoneExt":71,"email":117},"Anne-Françoise Rousseau, MD, PhD","anne-francoise.rousseau@mcgill.ca",[119],{"facility":120,"status":121,"city":122,"state":123,"zip":71,"country":124,"countryCode":125,"cosmosGeoPoint":126,"geoPoint":131,"contacts":132},"McGill University Health Centre (MUHC)","RECRUITING","Montreal","Quebec","Canada","CA",{"type":127,"coordinates":128},"Point",[129,130],-73.58781,45.50884,{"lat":130,"lon":129},[133,134,135,136],{"name":105,"role":111,"phone":112,"phoneExt":113,"email":114},{"name":116,"role":111,"phone":112,"phoneExt":71,"email":117},{"name":105,"role":106,"phone":71,"phoneExt":71,"email":71},{"name":108,"role":106,"phone":71,"phoneExt":71,"email":71},{"type":106,"investigatorFullName":138,"investigatorTitle":139,"investigatorAffiliation":5,"oldNameTitle":71,"oldOrganization":71},"Thomas Schricker","Professor","100635766",false,"NCT07556952","Dex & Mastectomy Pain","Does the Perioperative Administration of Dexamethasone Increase the Incidence of Chronic Postmastectomy Pain? A Double-blind Randomized Controlled Trial","Inclusion Criteria:\n\n* Female patients aged 18-75 years who can provide consent\n* undergoing unilateral or bilateral mastectomy\n* with or without lymph node dissection and\u002For immediate reconstruction,\n* ASA physical status I-III.\n\nExclusion Criteria:\n\n* Male sex;\n* pre-existing chronic pain conditions;\n* chronic opioid use;\n* pregnancy or breastfeeding;\n* breast surgery within the last three years;\n* chronic corticosteroid therapy;\n* contraindications to dexamethasone.","FEMALE","18 Years","75 Years",{"count":150,"type":151},170,"ESTIMATED","INTERVENTIONAL",[154],"PHASE4","Chronic post-surgical pain is a common complication following mastectomy and represents a significant source of long-term morbidity. Pain that persists beyond the expected period of tissue healing can interfere with physical functioning, psychological well-being, and quality of life. Despite advances in surgical and anesthetic techniques, the mechanisms contributing to chronic postmastectomy pain remain incompletely understood.\n\nDexamethasone is a corticosteroid routinely administered in the perioperative setting for the prevention of postoperative nausea and vomiting. In addition to its antiemetic properties, dexamethasone has potent anti-inflammatory and immunomodulatory effects that may influence tissue healing and pain processing pathways. Given its widespread use during surgery, understanding its potential impact on long-term pain outcomes is clinically relevant.\n\nClinical observational studies examining the association between perioperative dexamethasone administration and chronic postmastectomy pain have not demonstrated a clear or consistent relationship. However, by design, observational studies cannot establish causality or definitively exclude a potential effect of perioperative dexamethasone on the development of chronic post-surgical pain.\n\nIn contrast, preclinical studies using animal models of post-surgical pain have shown that perioperative exposure to dexamethasone may be associated with increased postoperative pain sensitivity and hyperalgesia. These findings suggest a potential biological mechanism through which perioperative corticosteroid administration could influence long-term pain outcomes, although their relevance to human surgical populations remains uncertain.\n\nTo date, no randomized controlled trials have directly evaluated whether perioperative dexamethasone administration affects the incidence of chronic postmastectomy pain in humans. Given the routine use of dexamethasone in perioperative care, the absence of definitive clinical evidence, and the presence of preclinical signals suggesting a possible effect on pain sensitization, a randomized, double-blind, placebo-controlled trial is warranted.\n\nThis study focuses on adult patients undergoing mastectomy, a population with a well-established risk of chronic post-surgical pain. Chronic pain will be assessed three months after surgery, a commonly accepted time point for distinguishing chronic post-surgical pain from normal postoperative recovery. The proposed study design aims to minimize bias and generate high-quality evidence to inform perioperative medication practices.",[157],"Post-Mastectomy Chronic Pain Syndrome",[159,160,161,162],"dexamethasone","mastectomy","chronic pain","post-operative","2026-06-02",{"date":165,"type":166},"2026-06-04","ACTUAL",{"date":168,"type":166},"2026-04-13",{"date":170,"type":151},"2028-06-30",{"name":5,"class":6},1]