[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657339":3},{"organization":4,"outcomesModule":7,"designInfo":82,"detailedDescription":94,"studyPopulation":81,"armGroups":95,"interventions":108,"overallOfficials":122,"centralContacts":127,"locations":137,"responsibleParty":155,"collaborators":81,"id":157,"slug":158,"hasResults":159,"nctId":160,"briefTitle":161,"officialTitle":161,"acronym":81,"eligibilityCriteria":162,"healthyVolunteers":159,"sex":163,"minAge":164,"maxAge":165,"enrollmentInfo":166,"targetDuration":81,"studyType":169,"phases":170,"briefSummary":172,"conditions":173,"keywords":177,"overallStatus":180,"whyStopped":81,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":190},{"fullName":5,"class":6},"Centre hospitalier de l'Université de Montréal (CHUM)","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":81},[9],{"measure":10,"description":11,"timeFrame":12},"Regression of sensory block by 2 dermatomes","Loss of pinprick sensation by Von Frey filaments from the injection of chloroprocaine for spinal anesthesia until regression of the sensory block by two dermatomes from the peak sensory level","At regression of spinal anesthesia by 2 dermatomes, approximately 60 minutes after surgery",[14,18,21,25,28,31,35,38,42,45,48,51,54,57,60,63,67,71,74,77],{"measure":15,"description":16,"timeFrame":17},"Duration of motor block","Using the Bromage scale from the time of injection of chloroprocaine for spinal anesthesia until complete recovery of motor block","At 5,10,15 and 20 minutes following spinal anesthesia, then every 10 minutes until complete recovery, approximately 90 minutes after surgery",{"measure":19,"description":20,"timeFrame":17},"Time until the first observable regression of the motor block","Time between the local anesthesic injection and the first measurable regression of the motor block measured using the Bromage scale.",{"measure":22,"description":23,"timeFrame":24},"Onset of sensory block","Time from injection of chloroprocaine for spinal anesthesia to reduction of sensitivity using loss of pinprick sensation","Up to 30 minutes following spinal anesthesia",{"measure":26,"description":27,"timeFrame":24},"Onset of motor block","Time from injection of chloroprocaine for spinal anesthesia to reduction of lower limbs movement using the Bromage scale",{"measure":29,"description":30,"timeFrame":24},"Quality of motor block","Maximal Bromage score The Bromage scale is a standardized tool used in neuraxial anesthesia to quantify motor block intensity in the lower extremities. It assesses a patient's ability to move their legs and feet. A scale of 0 to 3 is used: 0 - Full movement, 1- Partial block, 2 - Nearly complete block and 3 - Complete block.\n\nThe maximal Bromage score reflects the deepest level of lower-limb motor block, with higher scores indicating stronger motor impairment and therefore a denser motor block.",{"measure":32,"description":33,"timeFrame":34},"Opioid consumption","Total dose of opioids","At recovery room discharge, approximately one hour after the end of surgery",{"measure":36,"description":37,"timeFrame":34},"Antiemetic consumption","Total dose of antiemetics",{"measure":39,"description":40,"timeFrame":41},"Incidence of hypotension","Systolic blood pressure lower than 90 mm Hg","From injection of chloroprocaine for spinal anesthesia to recovery room discharge, approximately one hour after the end of the surgery",{"measure":43,"description":44,"timeFrame":41},"Incidence of bradycardia","Heart rate slower than 50 beats per minute",{"measure":46,"description":47,"timeFrame":41},"Incidence of nausea","Any episode of nausea reported by the patient or nursing team",{"measure":49,"description":50,"timeFrame":41},"Incidence of vomiting","Any episode of retching or vomiting reported by the patient or nursing team",{"measure":52,"description":53,"timeFrame":41},"Incidence of itching","Any episode of itching reported by the patient or nursing team",{"measure":55,"description":56,"timeFrame":41},"Incidence of urinary retention","Any episode of urinary retention reported by the patient or nursing team",{"measure":58,"description":59,"timeFrame":41},"Incidence of shivering","Any episode of shivering reported by the patient or nursing team",{"measure":61,"description":62,"timeFrame":41},"Incidence of headache","Any episode of headache reported by the patient or nursing team",{"measure":64,"description":65,"timeFrame":66},"Quality of postoperative recovery","QoR15 is a valid questionnaire to measure the quality of recovery after surgery and anaesthesia, which includes 15 questions. Each of the 15 items are scored by the patient from 0 (worst score) to 10 (optimal score), giving a lowest possible score of 0 (worst outcome), and a highest possible score of 150 (optimal outcome).","At 24 hours after the surgery",{"measure":68,"description":69,"timeFrame":70},"Intensity of nausea\u002Fvomiting","Pre-established analysis of nausea\u002Fvomiting intensity at 24 hours based on the QoR-15 question. QoR15 is a valid questionnaire to measure the quality of recovery after surgery and anaesthesia, which includes 15 questions. Each of the 15 items are scored by the patient from 0 (worst score) to 10 (optimal score).","At 24 hours after surgery",{"measure":72,"description":73,"timeFrame":70},"Pain intensity","Pre-established analysis of pain intensity at 24 hours based on the QoR-15. QoR15 is a valid questionnaire to measure the quality of recovery after surgery and anaesthesia, which includes 15 questions. Each of the 15 items are scored by the patient from 0 (worst score) to 10 (optimal score).",{"measure":75,"description":76,"timeFrame":70},"Quality of sleep","Pre-established analysis of sleep quality at 24 hours based on the QoR-15. QoR15 is a valid questionnaire to measure the quality of recovery after surgery and anaesthesia, which includes 15 questions. Each of the 15 items are scored by the patient from 0 (worst score) to 10 (optimal score).",{"measure":78,"description":79,"timeFrame":80},"Surgeon's satisfaction towards spinal anesthesia","Unsatisfied or satisfied","At the end of surgery, on the day of randomization",null,{"allocation":83,"interventionModel":84,"interventionModelDescription":85,"primaryPurpose":6,"observationalModel":81,"timePerspective":81,"maskingInfo":86},"RANDOMIZED","PARALLEL","Prospective, randomized, double-blind, placebo-controlled study",{"masking":87,"maskingDescription":88,"whoMasked":89},"QUADRUPLE","Patients in both groups will receive the study drug (dexamethasone or placebo) in the same volume of normal saline. The study drug will be prepared by an independent assistant.",[90,91,92,93],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","Spinal anesthesia is commonly used for lower body surgery. The injection of local anesthetics in the lumbar intrathecal space allows the desensitization of the lower body by blocking sensory and motor nerve roots. In return, spinal anesthesia causes a sympathetic block which is associated with deleterious hemodynamic effects such as hypotension.\n\nIsobaric chloroprocaine is a local anesthetic increasingly used for spinal anesthesia to reduce the duration of sensory and motor blocks compared to bupivacaine, allowing for faster postoperative recovery. However, certain medications used during surgery may possibly influence the duration of spinal anesthesia. Among these is dexamethasone, a drug belonging to the corticosteroid family. Dexamethasone is a well-known and commonly used medication in anesthesia to prevent postoperative nausea and vomiting. It is also used by anesthesiologists to reduce pain in the context of fast functional recovery after surgery. The safety of single-dose intravenous dexamethasone is therefore established in the context of anesthesia for several types of surgery.\n\nMedical literature demonstrates that dexamethasone can prolong the effect of certain local anesthetics when administered intravenously or perineurally (near the nerves), and sometimes has no effect on the duration of local anesthetics administered for spinal anesthesia. Currently, no information is available in the literature on the effect of intravenous dexamethasone on the duration of a spinal anesthesia with isobaric chloroprocaine.\n\nThis study aims to compare the effect of a single dose of 8 mg of intravenous dexamethasone versus placebo on the duration of sensory and motor block after spinal anesthesia with chloroprocaine.",[96,102],{"label":97,"type":98,"description":99,"interventionNames":100},"Intravenous dexamethasone","ACTIVE_COMPARATOR","During the performance of spinal anesthesia using isobaric 1% chloroprocaine 50 mg, an intravenous infusion of dexamethasone 8 mg (2 ml) will be initiated. The study drug will be administered intravenously over one minute. The study drug will be prepared by an independent assistant.",[101],"Drug: Intravenous Dexamethasone",{"label":103,"type":104,"description":105,"interventionNames":106},"Intravenous normal saline","PLACEBO_COMPARATOR","During the performance of spinal anesthesia using isobaric 1% chloroprocaine 50 mg, an intravenous infusion of 2 ml of Normal Saline will be initiated. The normal saline will be administered intravenously over one minute. The study drug will be prepared by an independent assistant.",[107],"Drug: Normal Saline",[109,116],{"type":110,"name":111,"description":112,"armGroupLabels":113,"otherNames":114},"DRUG","Intravenous Dexamethasone","Administration of a single-dose of intravenous dexamethasone 8 mg during spinal anesthesia with chloprocaine",[97],[115],"Decadron",{"type":110,"name":117,"description":118,"armGroupLabels":119,"otherNames":120},"Normal Saline","Administration of a single-dose of Normal saline during spinal anesthesia with chloprocaine",[103],[121],"Placebo",[123],{"name":124,"affiliation":125,"role":126},"Stephan Williams, MD, PhD","Santé Québec - CHUM","PRINCIPAL_INVESTIGATOR",[128,133],{"name":124,"role":129,"phone":130,"phoneExt":131,"email":132},"CONTACT","514-890-8000","12132","stephan.williams@umontreal.ca",{"name":134,"role":129,"phone":130,"phoneExt":135,"email":136},"Julie Desroches, PhD","24542","anesthesie.recherche.chum@ssss.gouv.qc.ca",[138],{"facility":139,"status":81,"city":140,"state":141,"zip":142,"country":143,"countryCode":144,"cosmosGeoPoint":145,"geoPoint":150,"contacts":151},"Santé Québec - Centre hospitalier de l'Université de Montréal","Montreal","Quebec","H2X 3E4","Canada","CA",{"type":146,"coordinates":147},"Point",[148,149],-73.58781,45.50884,{"lat":149,"lon":148},[152,153,154],{"name":124,"role":129,"phone":130,"phoneExt":131,"email":132},{"name":134,"role":129,"phone":130,"phoneExt":135,"email":136},{"name":124,"role":126,"phone":81,"phoneExt":81,"email":81},{"type":156,"investigatorFullName":81,"investigatorTitle":81,"investigatorAffiliation":81,"oldNameTitle":81,"oldOrganization":81},"SPONSOR","100657339","impact-of-intravenous-dexamethasone-on-the-duration-of-motor-and-sensory-block-following-spinal-anesthesia-with-chloroprocaine-100657339",false,"NCT07837674","Impact of Intravenous Dexamethasone on the Duration of Motor and Sensory Block Following Spinal Anesthesia With Chloroprocaine","Inclusion Criteria:\n\n* Age between 18 and 90 years old\n* ASA status I to III inclusively\n* Planned lower body surgery under spinal anesthesia with chloroprocaine\n* Signed informed consent form\n\nExclusion Criteria:\n\n* Contraindication to spinal anesthesia: infection at the puncture site, congenital or acquired coagulopathy\n* Preexisting neuropathy or nerve block that could interfere with study assessments\n* Allergy or hypersensitivity to local anesthetics, dexamethasone, or other medications used in the study\n* Preoperative use of corticosteroids\n* Patient refusal\n* Inability to consent\n* Language barrier, psychiatric, physical, or mental condition making sensory and motor blocks assessment impossible despite prior instruction\n* Administration of any intrathecal adjuvant (fentanyl, morphine, clonidine, dexmedetomidine, epinephrine, or others) along with chloroprocaine\n* Perioperative intravenous dexmedetomidine administration\n* Conversion to general anesthesia\n* Impossible post-anesthesia care unit assessment: patient still intubated \u002F transfer to intensive care unit, research team constraints, or other reasons\n* Assessment in the recovery room impossible: medical condition (shock, delirium, major agitation, altered state of consciousness, or other), transfer to the intensive care unit, research team constraints, or other","ALL","18 Years","90 Years",{"count":167,"type":168},60,"ESTIMATED","INTERVENTIONAL",[171],"NA","The purpose of this study is to compare the effect of a single dose of 8 mg of intravenous dexamethasone versus placebo on the duration of sensory and motor block after spinal anesthesia with chloroprocaine.",[174,175,176],"Spinal Anesthesia","Prolonged Sensory Block","Prolonged Motor Block",[178,179],"Dexamethasone","Chloroprocaine","NOT_YET_RECRUITING","2026-10-05",{"date":183,"type":184},"2026-10-08","ACTUAL",{"date":186,"type":168},"2026-11",{"date":188,"type":168},"2027-11",{"name":5,"class":6},1]