[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100576442":3},{"organization":4,"armGroups":7,"interventions":35,"overallOfficials":40,"centralContacts":40,"locations":54,"responsibleParty":74,"collaborators":40,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":40,"eligibilityCriteria":84,"healthyVolunteers":80,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":40,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":40,"overallStatus":56,"whyStopped":40,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Beijing Tiantan Hospital","OTHER",[8,14,19,24,29],{"label":9,"type":10,"description":11,"interventionNames":12},"intervention group 1","EXPERIMENTAL","0.012%diprospan+0.5%ropivacaine",[13],"Drug: 0.012%diprospan+0.5%ropivacaine",{"label":15,"type":10,"description":16,"interventionNames":17},"intervention group 2","0.009%diprospan+0.5%ropivacaine",[18],"Drug: 0.009%diprospan+0.5%ropivacaine",{"label":20,"type":10,"description":21,"interventionNames":22},"intervention group 3","0.006%diprospan+0.5%ropivacaine",[23],"Drug: 0.006%diprospan+0.5ropivacaine",{"label":25,"type":10,"description":26,"interventionNames":27},"intervention group 4","0.003%diprospan+0.5%ropivacaine",[28],"Drug: 0.003%diprospan+0.5%ropivacaine",{"label":30,"type":31,"description":32,"interventionNames":33},"control group","ACTIVE_COMPARATOR","0.5%ropivacaine",[34],"Drug: 0.5%ropivacaine",[36,41,44,48,51],{"type":37,"name":11,"description":38,"armGroupLabels":39,"otherNames":40},"DRUG","At the preoperative visit, patients will sign informed consent and learn to use the patient-controlled analgesia (PCA) pump and assess pain with the visual analogue scale (VAS). Standard general anesthesia will be induced and maintained with sufentanil, propofol, cisatracurium or rocuronium, and sevoflurane. Before incision, neurosurgeons will administer the allocated local infiltration solution. 0.5ml of diprospan will be diluted to 30 ml with 15 ml of ropivacaine in 0.9% NaCl to prepare diprospan at concentrations of 0.012%, respectively. The surgeon will use a 22 G straight needle for local infiltration anesthesia near the planned incisions. Postoperatively, patients will receive tropisetron and a PCA pump delivering sufentanil and ondansetron. PCA usage (effective\u002Fineffective presses) and supplemental analgesia with Tylenol or loxoprofen will be monitored for 48 hours and up to 3 months. Dosages and intraoperative parameters will be closely recorded throughout.",[9],null,{"type":37,"name":16,"description":42,"armGroupLabels":43,"otherNames":40},"At the preoperative visit, patients will sign informed consent and learn to use the patient-controlled analgesia (PCA) pump and assess pain with the visual analogue scale (VAS). Standard general anesthesia will be induced and maintained with sufentanil, propofol, cisatracurium or rocuronium, and sevoflurane. Before incision, neurosurgeons will administer the allocated local infiltration solution. 0.375ml of diprospan will be diluted to 30 ml with 15 ml of ropivacaine in 0.9% NaCl to prepare diprospan at concentrations of 0.009%, respectively. The surgeon will use a 22 G straight needle for local infiltration anesthesia near the planned incisions. Postoperatively, patients will receive tropisetron and a PCA pump delivering sufentanil and ondansetron. PCA usage (effective\u002Fineffective presses) and supplemental analgesia with Tylenol or loxoprofen will be monitored for 48 hours and up to 3 months. Dosages and intraoperative parameters will be closely recorded throughout.",[15],{"type":37,"name":45,"description":46,"armGroupLabels":47,"otherNames":40},"0.006%diprospan+0.5ropivacaine","At the preoperative visit, patients will sign informed consent and learn to use the patient-controlled analgesia (PCA) pump and assess pain with the visual analogue scale (VAS). Standard general anesthesia will be induced and maintained with sufentanil, propofol, cisatracurium or rocuronium, and sevoflurane. Before incision, neurosurgeons will administer the allocated local infiltration solution. 0.25ml of diprospan will be diluted to 30 ml with 15 ml of ropivacaine in 0.9% NaCl to prepare diprospan at concentrations of 0.006%, respectively. The surgeon will use a 22 G straight needle for local infiltration anesthesia near the planned incisions. Postoperatively, patients will receive tropisetron and a PCA pump delivering sufentanil and ondansetron. PCA usage (effective\u002Fineffective presses) and supplemental analgesia with Tylenol or loxoprofen will be monitored for 48 hours and up to 3 months. Dosages and intraoperative parameters will be closely recorded throughout.",[20],{"type":37,"name":26,"description":49,"armGroupLabels":50,"otherNames":40},"At the preoperative visit, patients will sign informed consent and learn to use the patient-controlled analgesia (PCA) pump and assess pain with the visual analogue scale (VAS). Standard general anesthesia will be induced and maintained with sufentanil, propofol, cisatracurium or rocuronium, and sevoflurane. Before incision, neurosurgeons will administer the allocated local infiltration solution. 0.125ml of diprospan will be diluted to 30 ml with 15 ml of ropivacaine in 0.9% NaCl to prepare diprospan at concentrations of 0.003%, respectively. The surgeon will use a 22 G straight needle for local infiltration anesthesia near the planned incisions. Postoperatively, patients will receive tropisetron and a PCA pump delivering sufentanil and ondansetron. PCA usage (effective\u002Fineffective presses) and supplemental analgesia with Tylenol or loxoprofen will be monitored for 48 hours and up to 3 months. Dosages and intraoperative parameters will be closely recorded throughout.",[25],{"type":37,"name":32,"description":52,"armGroupLabels":53,"otherNames":40},"At the preoperative visit, patients will sign informed consent and learn to use the patient-controlled analgesia (PCA) pump and assess pain with the visual analogue scale (VAS). Standard general anesthesia will be induced and maintained with sufentanil, propofol, cisatracurium or rocuronium, and sevoflurane. Before incision, neurosurgeons will administer the allocated local infiltration solution. 15 ml of ropivacaine will be diluted to 30 ml with in 0.9% NaCl, respectively. The surgeon will use a 22 G straight needle for local infiltration anesthesia near the planned incisions. Postoperatively, patients will receive tropisetron and a PCA pump delivering sufentanil and ondansetron. PCA usage (effective\u002Fineffective presses) and supplemental analgesia with Tylenol or loxoprofen will be monitored for 48 hours and up to 3 months. Dosages and intraoperative parameters will be closely recorded throughout.",[30],[55],{"facility":5,"status":56,"city":57,"state":58,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"RECRUITING","Beijing","Beijing Municipality","100070","China","CN",{"type":63,"coordinates":64},"Point",[65,66],116.39723,39.9075,{"lat":66,"lon":65},[69],{"name":70,"role":71,"phone":72,"phoneExt":40,"email":73},"Fang Luo, M.D.","CONTACT","+86 13611326978","13611326978@163.com",{"type":75,"investigatorFullName":76,"investigatorTitle":77,"investigatorAffiliation":5,"oldNameTitle":40,"oldOrganization":40},"PRINCIPAL_INVESTIGATOR","Fang Luo","Director of Department of Pain Management","100576442","minimum-effective-dose-of-incisional-local-infiltration-betamethasone-for-the-prevention-of-pain-after-spinal-surgery-100576442",false,"NCT06785350","Minimum Effective Dose of Incisional Local Infiltration Betamethasone for the Prevention of Pain After Spinal Surgery","Minimum Effective Dose of Incisional Local Infiltration Betamethasone for the Prevention of Pain After Spinal Surgery: a Randomised Controlled Trial","Inclusion Criteria:\n\nPatients scheduled for spine surgery under general anesthesia. Anticipated cervical, thoracic, and lumbar spine surgeries (within three level).\n\nPatients age 18-65 years. American Society of Anaesthesiologists Classification of I or II.\n\nExclusion Criteria:\n\nPatients refuse to participate. Patients who are allergic to ropivacaine, betamethasone and opioid, . Pateints who have been abusing drugs or alcohol. Patients who have abnormalities in kidney or liver function tests. BMI\\\u003C15kg\u002Fm2 or\\>35 kg\u002Fm2. Patient has a history of spinal surgery. Patient has peri-incisional infection. Patient has a history of stroke or other serious neurological disease. Patient has a history of diabetes and other metabolic disorders. Patient has a history of psychological disorders. Patient is on systemic steroids. Patient is pregnant or breastfeeding. Glasgow Coma Scale score \\\u003C 15 before surgery. Unable to provide written informed consent.\n\nWithdrawal criteria:\n\nVoluntary withdrawal. Delayed extubation. Poor cognitive function within 48 hours after surgery. Postoperative radiation therapy or chemotherapy during follow-up. Postoperative diagnosis of spinal cord or nerve root injury resulting in pain during follow-up.\n\nReoperation during follow-up.","ALL","18 Years","65 Years",{"count":89,"type":90},535,"ESTIMATED","INTERVENTIONAL",[93],"NA","Incisional pain is a common complication after surgery and is an important cause of delayed postoperative recovery, increased length of hospital stay, increased risk of wound infection and respiratory\u002Fcardiovascular complications, as well as an important medical, social, and economic problem. Prevention and treatment of postoperative incision pain remains challenging. Local Infiltration Anaesthesia (LIA) for surgical incisions with an anti-inflammatory and analgesic combination has been reported to be effective in reducing postoperative pain, but there is a gap in the research on the optimal concentration of anti-inflammatory drugs in the anti-inflammatory and analgesic combination during local infiltration. The aim of this study was to investigate the optimal concentration of anti-inflammatory drugs in the anti-inflammatory-analgesic combination solution used for local infiltration of spinal surgical incisions to prevent postoperative pain.",[96,97],"Pain Management","Spine Surgery","2025-07-11",{"date":100,"type":101},"2025-07-16","ACTUAL",{"date":103,"type":101},"2025-01-25",{"date":105,"type":90},"2025-12-01",{"name":5,"class":6},1]