[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644857":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":43,"centralContacts":48,"locations":57,"responsibleParty":70,"collaborators":53,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":53,"eligibilityCriteria":80,"healthyVolunteers":76,"sex":81,"minAge":82,"maxAge":53,"enrollmentInfo":83,"targetDuration":53,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":99,"whyStopped":53,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Centre of Postgraduate Medical Education","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Perioperative lidocaine infusion","EXPERIMENTAL","Intravenous lidocaine bolus of 1.5 mg\u002Fkg administered over 10 minutes before induction of anesthesia, followed by continuous infusion at 1.5 mg\u002Fkg\u002Fh until the end of surgery.",[13],"Procedure: Perioperative lidocaine infusion",{"label":15,"type":10,"description":16,"interventionNames":17},"Perioperative dexmedetomidine infusion","Intravenous dexmedetomidine bolus of 0.6 mcg\u002Fkg administered over 10 minutes before induction of anesthesia, followed by continuous infusion at 0.6 mcg\u002Fkg\u002Fh until the end of surgery",[18],"Procedure: Perioperative dexmedetomidine infusion",{"label":20,"type":21,"description":22,"interventionNames":23},"Perioperative 0.9% NaCl infusion","PLACEBO_COMPARATOR","The infusion of 0.9% NaCl will then be started at a rate of 0.9 mL\u002Fkg\u002Fh and continued for 10 minute. Subsequently, the infusion will be continued until placement of the final skin suture at a rate of 0.15 mL\u002Fkg\u002Fh.",[24],"Procedure: Perioperative placebo infusion",[26,32,37],{"type":27,"name":9,"description":28,"armGroupLabels":29,"otherNames":30},"PROCEDURE","The study drug infusion will be started prior ti induction of general anesthesia at a rate of 0.9 mL\u002Fkg\u002Fh and continued for 10 minutes, corresponding to a dose of 1.5 mg\u002Fkg lidocaine. Subsequently, the infusion will be continued until placement of the final skin suture at a rate of 0.15 mL\u002Fkg\u002Fh, corresponding to 1.5 mg\u002Fkg\u002Fh of lidocaine.",[9],[31],"Intravenous infusion of lidocaine solution using infusion pump.",{"type":27,"name":15,"description":33,"armGroupLabels":34,"otherNames":35},"The study drug infusion will be started at a rate of 0.9 mL\u002Fkg\u002Fh and continued for 10 minutes, corresponding to a dose of 0.6 μg\u002Fkg dexmedetomidine. Subsequently, the infusion will be continued until placement of the final skin suture at a rate of 0.15 mL\u002Fkg\u002Fh, corresponding to 0.6 mcg\u002Fkg\u002Fh of dexmedetomidine.",[15],[36],"Intravenous infusion of dexmedetomidine using infusion pump.",{"type":27,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"Perioperative placebo infusion","The 0.9% NaCl infusion will be started at a rate of 0.9 mL\u002Fkg\u002Fh and continued for 10 minutes. Subsequently, the infusion will be continued until placement of the final skin suture at a rate of 0.15 mL\u002Fkg\u002Fh.",[20],[42],"Infusion of 0.9% NaCl using infusion pump.",[44],{"name":45,"affiliation":46,"role":47},"Małgorzata Malec-Milewska, MD, Prof.","Department of Anesthesia and Intensive Care, Orlowski Hospital, Warsaw","STUDY_CHAIR",[49,55],{"name":50,"role":51,"phone":52,"phoneExt":53,"email":54},"Bartosz Horosz, MD,PhD","CONTACT","0048225841122",null,"bartosz.horosz@gmail.com",{"name":56,"role":51,"phone":53,"phoneExt":53,"email":53},"Katarzyna Białowolska-Horosz, MD,PhD",[58],{"facility":59,"status":53,"city":60,"state":53,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":53},"Department of Anesthesiology and Intensive Care, Centre of Postgraduate Medical Education","Warsaw","01-355","Poland","PL",{"type":65,"coordinates":66},"Point",[67,68],21.01178,52.22977,{"lat":68,"lon":67},{"type":71,"investigatorFullName":72,"investigatorTitle":73,"investigatorAffiliation":5,"oldNameTitle":53,"oldOrganization":53},"PRINCIPAL_INVESTIGATOR","Bartosz Horosz, MD","MD,PhD","100644857","intraoperative-lidocaine-or-dexmedetomidine-for-postoperative-pain-modulation-after-urethral-reconstruction-100644857",false,"NCT07676942","Intraoperative Lidocaine or Dexmedetomidine for Postoperative Pain Modulation After Urethral Reconstruction.","Effects of Intravenous Lidocaine and Dexmedetomidine Infusions on Postoperative Pain and the Development of Chronic Pain Following Urethral Reconstruction Surgery: A Randomized, Double-Blind, Placebo-Controlled Trial.","Inclusion Criteria:\n\n* ASA status less or equal 3\n* Scheduled for reconstructive surgery of urethra\n* Able to understand information provided and to sign informed consent for participation in the study\n\nExclusion Criteria:\n\n* known allergy to one of the investigated medications\n* current chronic pain\n* known chronic use of opioids, gabapentinoids and antidepressants","MALE","18 Years",{"count":84,"type":85},80,"ESTIMATED","INTERVENTIONAL",[88],"NA","The development of chronic postoperative pain (CPP) following surgery is influenced by several factors, among which the intensity of acute postoperative pain in the immediate perioperative period and mechanisms related to nerve fiber injury play a crucial role. Previous studies have demonstrated that factors such as the severity of early postoperative pain, patient age, and the extent of surgical intervention may increase the risk of transition from acute to chronic pain. In recent years, growing attention has been directed toward anesthetic techniques and adjuvant analgesics (co-analgesics) administered during surgery, which may potentially reduce the incidence of CPP.\n\nThe aim of this study is to evaluate the effects of intraoperative intravenous infusions of dexmedetomidine or lidocaine during urethral reconstructive surgery on postoperative pain intensity, patient-reported quality of recovery, and the incidence and characteristics of chronic postoperative pain, including its neuropathic component. In particular, the study will investigate whether administration of these agents reduces pain intensity during the first 48 hours after surgery-which, according to existing evidence, may correlate with the risk of CPP development-and whether intraoperative infusion of lidocaine or dexmedetomidine translates into reduced pain severity and a lower risk of neuropathic pain at long-term follow-up (3, 6, and 12 months after surgery).\n\nAn important aspect of this project is that both investigational drugs-lidocaine and dexmedetomidine-have an established role in routine anesthesiology practice, and their safety profiles are well characterized and extensively documented in the medical literature. Intravenous lidocaine infusion has been used for many years as part of multimodal perioperative analgesia; numerous randomized controlled trials and meta-analyses have confirmed its efficacy in reducing postoperative pain intensity and opioid requirements, with a low risk of adverse effects when administered at therapeutic doses. Dexmedetomidine has been routinely used for years both in intensive care units and as a component of general anesthesia across a wide range of surgical procedures. Its analgesic, anxiolytic, and opioid-sparing effects have been supported by a substantial body of clinical evidence, and the doses used in the present protocol are consistent with established clinical practice.",[91],"Urethral Stricture",[93,94,95,96,97,98],"urethral reconstruction","buccal membrane graft","postoperative pain","neuropathic pain","lidocaine","dexmedetomidine","NOT_YET_RECRUITING","2026-06-23",{"date":102,"type":103},"2026-06-30","ACTUAL",{"date":105,"type":85},"2026-06",{"date":107,"type":85},"2028-07",{"name":5,"class":6},1]