[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644703":3},{"organization":4,"outcomesModule":7,"designInfo":72,"detailedDescription":83,"studyPopulation":71,"armGroups":84,"interventions":98,"overallOfficials":71,"centralContacts":112,"locations":118,"responsibleParty":136,"collaborators":71,"id":138,"slug":71,"hasResults":139,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":93,"eligibilityCriteria":143,"healthyVolunteers":139,"sex":144,"minAge":145,"maxAge":71,"enrollmentInfo":146,"targetDuration":71,"studyType":149,"phases":150,"briefSummary":152,"conditions":153,"keywords":155,"overallStatus":162,"whyStopped":71,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":172},{"fullName":5,"class":6},"CMC Ambroise Paré","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":71},[9],{"measure":10,"description":11,"timeFrame":12},"Time to regression of sensory block by two dermatomes (pin-prick test)","Time (in minutes) from the spinal puncture to the first assessment at which the sensory block has regressed by two dermatomes from the maximum (highest\u002Fmost cephalad) dermatome level of sensory block achieved after the puncture, assessed with the pin-prick test. Sensory testing will be performed every 5 minutes until two-dermatome regression is observed. Responses will be recorded as: 2 = sharp (normal sensation), 1 = dull (decreased sensation), and 0 = absent sensation.","Up to 2 hours following spinal anesthesia",[14,18,21,25,28,32,35,39,42,45,48,51,54,58,61,64,68],{"measure":15,"description":16,"timeFrame":17},"Time to complete resolution of motor block","Time (in minutes) from the spinal puncture to complete recovery of motor block, assessed by the Modified Bromage Scale (0-3: 0 = full flexion of hip, knee, and ankle; 1 = inability to raise extended leg; 2 = inability to flex knee; 3 = no movement of hip, knee, or ankle). Motor block will be assessed every 5 minutes after the spinal puncture until regression of the sensory block by two dermatomes, and then every 10 minutes until complete motor recovery (Bromage 0).","Up to 8 hours following spinal anesthesia",{"measure":19,"description":20,"timeFrame":17},"Time to regression of sensory block by four dermatomes (pin-prick test)","Time (in minutes) from the spinal puncture to regression of four dermatomes from the highest dermatome level of sensory block achieved after the puncture. Sensory block will be assessed using the pin-prick test every 5 minutes after the spinal puncture until regression by two dermatomes, and then every 10 minutes until regression by four dermatomes. Responses will be recorded as: 2 = sharp (normal sensation), 1 = dull (decreased sensation), and 0 = absent sensation.",{"measure":22,"description":23,"timeFrame":24},"Maximum sensory block level","Highest dermatome level of sensory block achieved after the spinal puncture (pin-prick test).","Up to 30 minutes following spinal anesthesia",{"measure":26,"description":27,"timeFrame":24},"Time to maximum sensory block level","Time (in minutes) from the spinal puncture to the highest blocked dermatome (pin-prick test).",{"measure":29,"description":30,"timeFrame":31},"Need for additional anesthetic procedure","Whether an additional anesthetic procedure was required during surgery, including sedation or conversion to general anesthesia","From spinal anesthesia to the end of surgery",{"measure":33,"description":34,"timeFrame":12},"Time to regression of sensory block by two dermatomes (cold test)","Time (in minutes) from spinal puncture to two dermatome sensory regression assessed by a standardized cold test",{"measure":36,"description":37,"timeFrame":38},"Incidence of hypotension","Any episode of hypotension, defined as a systolic blood pressure (SBP) \\\u003C 90 mmHg and\u002For a mean arterial pressure (MAP) \\\u003C 65 mmHg and\u002For a decrease in blood pressure ≥ 30% from baseline","From spinal anesthesia to 24 hours after surgery",{"measure":40,"description":41,"timeFrame":38},"Incidence of bradycardia","Any episode of bradycardia defined as a heart rate (HR) \\\u003C 50 bpm",{"measure":43,"description":44,"timeFrame":38},"Incidence of nausea","Any episode of nausea reported by the patient or nursing team",{"measure":46,"description":47,"timeFrame":38},"Incidence of vomiting","Any episode of vomiting reported by the patient or nursing team",{"measure":49,"description":50,"timeFrame":38},"Incidence of pruritus","Any episode of pruritus reported by the patient or nursing team",{"measure":52,"description":53,"timeFrame":38},"Incidence of urinary retention","Any episode of urinary retention reported by the patient or nursing team",{"measure":55,"description":56,"timeFrame":57},"Maximal pain score in the PACU","Maximal pain score collected in the PACU using a Numeric Rating Scale (NRS-Pain) ranging from 0 to 10 (0= no pain; 10= extreme pain).","Up to 6 hours following spinal anesthesia",{"measure":59,"description":60,"timeFrame":38},"Total opioid consumption","Total opioid consumption, converted to oral morphine equivalents (OME, mg) from the intraoperative period to 24 hours postoperatively, including opioid use at home as reported during the Day 1 follow-up",{"measure":62,"description":63,"timeFrame":38},"Pain intensity","Pain intensity at rest and during movement will be assessed using a Numeric Rating Scale (NRS-Pain) ranging from 0 to 10 (0= no pain; 10= extreme pain). Pain scores will be recorded intraoperatively (H0)in the PACU (H1), during ambulatory hospitalization (H3 and H6), and at home until Day-1 (H9, H12 and H24).",{"measure":65,"description":66,"timeFrame":67},"Duration of surgery","Time (in minutes) between the skin incision and the last suture","Intraoperative period",{"measure":69,"description":70,"timeFrame":38},"Incidence of post-puncture headache","Any episode of headache reported by the patient or nursing team",null,{"allocation":73,"interventionModel":74,"interventionModelDescription":71,"primaryPurpose":75,"observationalModel":71,"timePerspective":71,"maskingInfo":76},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":77,"maskingDescription":71,"whoMasked":78},"QUADRUPLE",[79,80,81,82],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","This is a monocenter, prospective, randomized (1:1 ratio), controlled, parallel-group, double-blind, phase III superiority trial assessing the efficacy and the safety of IV dexamethasone for prolonging sensory block in patients undergoing knee arthroscopy under spinal anesthesia with chloroprocaine.\n\nParticipants will be randomly allocated into two groups:\n\n* Group CHLORO (control group): Patients will receive spinal anesthesia with chloroprocaine 40mg (Clorotekal®10 mg\u002FmL, solution for injection, 4 mL) combined with an IV infusion of 3 mL of normal saline solution diluted in 100 mL of 0.9% sodium chloride, administered over 20 minutes.\n* Group CHLORODEX (experimental group): Patients will receive spinal anesthesia with chloroprocaine 40 mg (Clorotekal®10 mg\u002FmL, solution for injection, 4 mL) combined with an IV infusion of dexamethasone at a dose of 0.15 mg\u002FKg (maximum 16 mg), diluted in 100 mL of 0.9% sodium chloride, administered over 20 minutes.\n\nTo ensure blinding, study infusions (saline or dexamethasone) will be prepared in identical 100 mL bags and labelled by a pharmacy staff member or an \"outside protocol\" healthcare professional (physician or nurse) not involved in patient care or assessment.\n\nThe infusion will start approximately 10-15 minutes before the spinal punction.\n\nIn the operating room, patients will receive standard perioperative care for spinal anesthesia, including placement of a peripheral intravenous line, supplemental low-flow oxygen therapy to maintain SpO₂ \\> 93%, continuous hemodynamic monitoring, and strict aseptic precautions. Analgesic premedication with paracetamol combined with either ketoprofen or celecoxib will be administered according to institutional practice.\n\nSpinal anesthesia will be performed with the patient in a semi-sitting position via the L3-L4 or L4-L5 interspace using a 25G x 80mm Sprotte needle. After cerebrospinal fluid reflux, 40 mg of chloroprocaine without adjuvant will be injected intrathecally, and patients will then be positioned in the supine position for the procedure.\n\nKnee arthroscopy will be performed according to standard surgical practice, without any modification of the surgical procedure for study purposes.\n\nNo additional sedation or analgesia will be administered during the procedure. In the event of failure of spinal anesthesia or early recovery of sensation, conversion to general anesthesia or deep sedation may be performed at the discretion of the anesthesiologist, depending on the clinical situation.\n\nPostoperatively, multimodal analgesia will be initiated according to the institutional protocol, combining paracetamol, nefopam, and either ketoprofen or celecoxib, with morphine administered if necessary.\n\nSensory and motor blocks will be assessed every 5 minutes after spinal puncture until regression of two dermatomes and then every 10 minutes until recovery of four dermatomes and complete motor function (maximum until hospital discharge).\n\nMotor block will be assessed using the Bromage score and sensory block will be assessed using the Pin Prick test and the cold test.\n\nThe primary objective of the study is to evaluate the efficacy of intravenous dexamethasone in prolonging sensory block following spinal anesthesia with chloroprocaine, as assessed by the time from intrathecal injection to regression of sensory block by two dermatomes from the highest level of sensory block achieved, as measured by the pin-prick test.",[85,92],{"label":86,"type":87,"description":88,"interventionNames":89},"CHLORO","PLACEBO_COMPARATOR","Normal saline solution IV infusion",[90,91],"Drug: Sodium Chloride 0.9%","Drug: Chloroprocaine Injection [Clorotekal]",{"label":93,"type":94,"description":95,"interventionNames":96},"CHLORODEX","EXPERIMENTAL","Dexamethasone IV infusion",[97,91],"Drug: Dexamethasone",[99,104,108],{"type":100,"name":101,"description":102,"armGroupLabels":103,"otherNames":71},"DRUG","Sodium Chloride 0.9%","IV infusion of 3 mL of normal saline solution diluted in 100 mL of 0.9% sodium chloride, administered over 20 minutes",[86],{"type":100,"name":105,"description":106,"armGroupLabels":107,"otherNames":71},"Dexamethasone","IV infusion of dexamethasone at a dose of 0.15 mg\u002Fkg (maximum 16 mg), diluted in 100 mL of 0.9% sodium chloride, administered over 20 minutes",[93],{"type":100,"name":109,"description":110,"armGroupLabels":111,"otherNames":71},"Chloroprocaine Injection [Clorotekal]","Spinal anesthesia with chloroprocaine 40 mg",[86,93],[113],{"name":114,"role":115,"phone":116,"phoneExt":71,"email":117},"Sébastien BLOC, MD","CONTACT","01 44 14 11 11","sebebloc@gmail.com",[119],{"facility":120,"status":71,"city":121,"state":122,"zip":123,"country":124,"countryCode":125,"cosmosGeoPoint":126,"geoPoint":131,"contacts":132},"Clinique Drouot Rémusat","Paris","Île-de-France Region","75016","France","FR",{"type":127,"coordinates":128},"Point",[129,130],2.3488,48.85341,{"lat":130,"lon":129},[133],{"name":134,"role":115,"phone":116,"phoneExt":71,"email":135},"Cyril QUEMENEUR, MD","c.quemeneur@gmx.com",{"type":137,"investigatorFullName":71,"investigatorTitle":71,"investigatorAffiliation":71,"oldNameTitle":71,"oldOrganization":71},"SPONSOR","100644703",false,"NCT07674576","Efficacy of Intravenous Dexamethasone in Prolonging the Duration of Spinal Anesthesia With Chloroprocaine in Knee Arthroscopy","Efficacy of Intravenous Dexamethasone in Prolonging the Duration of Spinal Anesthesia With Chloroprocaine in Knee Arthroscopy: a Double-blind, Randomized, Controlled Trial","Inclusion Criteria:\n\n* Undergoing knee arthroscopy lasting ≤ 40 minutes requiring spinal anesthesia (diagnostic arthroscopy or meniscal surgery),\n* Signed written informed consent form,\n* Affiliation to a social security system,\n* Negative pregnancy test on the day of procedure for non-menopausal patients.\n\nExclusion Criteria:\n\n* Contraindications to spinal anesthesia with intrathecal chloroprocaine\n* History of diabetes,\n* Pre-existing peripheral neuropathy,\n* American Society of Anesthesiologists (ASA) physical status IV,\n* Contraindication to dexamethasone,\n* Hypersensitivity of any drug used in this study,\n* Long-term oral corticosteroid therapy,\n* Chronic opioid use,\n* Chronic pain syndromes,\n* Contraindications to Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) (Ketoprofen, Celecoxib)\n* Need for a peripheral nerve block in addition to spinal anesthesia (e.g. knee ligamentoplasty),\n* Mental or linguistic inability to understand the study,\n* Patients under legal protection (guardianship, curatorship or safeguard of justice),\n* Patients currently included or planning to be included in another interventional study,\n* Pregnant or breastfeeding women,\n* Women of childbearing potential not using effective contraception.","ALL","18 Years",{"count":147,"type":148},60,"ESTIMATED","INTERVENTIONAL",[151],"PHASE3","Chloroprocaine is a short-acting local anesthetic that allows rapid recovery and early ambulation but is currently recommended for procedures lasting 40 minutes or less.\n\nDexamethasone is commonly used during anesthesia for the prevention of postoperative nausea and vomiting and has also been shown to prolong the duration of analgesia and sensory block after regional anesthesia.\n\nDexamethasone may therefore extend the duration of chloroprocaine spinal anesthesia, potentially allowing its use for longer surgical procedures while maintaining the benefits of rapid postoperative recovery.\n\nThis study aims to evaluate whether intravenous dexamethasone can prolong the effects of spinal anesthesia performed with chloroprocaine in adults undergoing knee arthroscopy.",[154],"Knee Arthroscopy",[156,157,158,159,160,161],"Knee arthroscopy","dexamethasone","chloroprocaine","spinal anesthesia","sensory block","motor block","NOT_YET_RECRUITING","2026-06-25",{"date":165,"type":166},"2026-06-29","ACTUAL",{"date":168,"type":148},"2026-09-01",{"date":170,"type":148},"2028-09-01",{"name":5,"class":6},1]