[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100599198":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":24,"locations":30,"responsibleParty":46,"collaborators":48,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":18,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":18,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":33,"whyStopped":18,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Sixth Affiliated Hospital, Sun Yat-sen University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Liposomal Bupivacaine Repeat Dosing Group","EXPERIMENTAL","A single dose of liposomal bupivacaine is administered at the conclusion of surgery without adjunctive analgesics, followed by a supplemental dose 72 hours postoperatively.",[13],"Drug: A single dose of liposomal bupivacaine is administered at the conclusion of surgery without adjunctive analgesics, followed by a supplemental dose 72 hours postoperatively.",{"label":15,"type":16,"description":17,"interventionNames":18},"Liposomal Bupivacaine Single-Injection Group","NO_INTERVENTION","A single dose of liposomal bupivacaine is administered at the conclusion of surgery without adjunctive analgesics.",null,[20],{"type":21,"name":11,"description":22,"armGroupLabels":23,"otherNames":18},"DRUG","At surgical closure, a single dose of undiluted liposomal bupivacaine (266 mg\u002F20 mL) is administered without concurrent analgesics. The total 20 mL volume is divided into six equal aliquots (≈3.3 mL each) and infiltrated circumferentially around the incision using a 25-gauge or larger-bore needle. Injections target tissue layers above and below the fascia and within the subcutaneous plane, with frequent aspiration during administration to mitigate intravascular injection risk. Seventy-two hours postoperatively, a repeat dose of undiluted liposomal bupivacaine (266 mg\u002F20 mL) is administered. Prior to infiltration, topical lidocaine cream is applied to the per-incisional skin for ≥20 minutes. The full 20 mL volume is then injected uniformly around the incision via circumferential needle advancement into pericicatricial tissues.",[9],[25],{"name":26,"role":27,"phone":28,"phoneExt":18,"email":29},"Hongcheng Lin, MD","CONTACT","+86 15915815776","lhcheng@mail.sysu.edu.cn",[31],{"facility":32,"status":33,"city":34,"state":35,"zip":18,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"The Sixth Affiliated Hospital of Sun Yat-sen University","RECRUITING","Guangzhou","Guangdong","China","CN",{"type":39,"coordinates":40},"Point",[41,42],113.25,23.11667,{"lat":42,"lon":41},[45],{"name":26,"role":27,"phone":28,"phoneExt":18,"email":29},{"type":47,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[49,52,54,56,58,60],{"name":50,"class":51},"The First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine","UNKNOWN",{"name":53,"class":6},"Maoming People's Hospital",{"name":55,"class":6},"Dongguan Hospital of Traditional Chinese Medicine",{"name":57,"class":51},"Xingyi People's Hospital",{"name":59,"class":51},"Nanjing Hospital of C. M.",{"name":61,"class":6},"People's Hospital of Xinjiang Uygur Autonomous Region","100599198","study-on-repeat-liposomal-bupivacaine-for-post-surgery-pain-in-anal-fistula-patients-100599198",false,"NCT07081373","Study on Repeat Liposomal Bupivacaine for Post-Surgery Pain in Anal Fistula Patients.","Efficacy of Repeat Dosing of Liposomal Bupivacaine on Postoperative Pain in Patients With Anal Fistula: A Multicenter, Randomized, Open-Label, Controlled Study","Inclusion Criteria:\n\n* Diagnosed with anal fistula and scheduled to undergo anal fistula surgery;\n* Aged between 18 and 60 years;\n* ASA (American Society of Anesthesiologists) physical status class I-II;\n* Patient provides written informed consent after understanding the study protocol.\n\nExclusion Criteria:\n\n* Anal fistula caused by specific etiologies (e.g., tuberculosis);\n* Concurrent acute perianal skin infection;\n* Poorly controlled diabetes (HbA1c \\>9%);\n* Chronic use of corticosteroids;\n* History of radiotherapy or chemotherapy within the past 2 weeks;\n* Pregnancy or lactation;\n* Hypersensitivity to local anesthetics or any component of the investigational drug;\n* History of substance abuse, illicit drug use, or alcohol abuse;\n* Use or planned use of non-opioid\u002Fopioid analgesics within 12 hours before\u002Fduring surgery;\n* Concurrent treatment with anticonvulsants, MAO inhibitors, antidepressants, neuromuscular blockers, or anticholinergics within 2 weeks prior to surgery;\n* Severe hepatic\u002Frenal impairment, cardiopulmonary dysfunction, coagulation disorders, or comorbidities contraindicating surgery;\n* History of severe psychiatric disorders or cognitive impairment;\n* Sensory disorders (e.g., hyperalgesia) or preexisting pain interfering with postoperative pain assessment;\n* Contraindications to amide-type local anesthetics, opioids, or propofol;\n* Participation in investigational drug trials within 90 days prior to enrollment;\n* Other clinical\u002Flaboratory conditions deemed by investigators to preclude trial participation.","ALL","18 Years","60 Years",{"count":73,"type":74},408,"ESTIMATED","INTERVENTIONAL",[77],"NA","Anal Fistula refers to an abnormal infectious fistula tract between the anorectum and the perianal skin. The prevalence of anal fistula is approximately 8.6 cases per 100,000 individuals. It can occur at any age but is relatively more common in individuals aged 20-40 years, with a higher incidence in males than females.\n\nPostoperative wound management is a critical component of the overall treatment for anal fistula patients. Regular postoperative wound care, such as dressing changes, can reduce recurrence rates, alleviate pain, and shorten hospitalization time. However, postoperative pain remains a major challenge in wound management following anal fistula surgery. This is largely attributed to inadequate current postoperative analgesic protocols.\n\nWith ongoing advancements in local anesthetics, liposomal bupivacaine has been applied for postoperative analgesia. It offers higher bioavailability and a prolonged half-life, providing up to 72 hours of sustained analgesic effect. Given the limitations of existing analgesic strategies for post-anal fistula surgery, developing more effective pain management approaches to reduce postoperative pain holds significant clinical importance.\n\nTherefore, the investigators propose that a repeat-dosing strategy based on liposomal bupivacaine may provide superior postoperative pain control for anal fistula patients. To investigate this, the investigators designed a prospective, multicenter, randomized, open-label, controlled clinical trial. This study aims to evaluate the efficacy and safety of repeat-dose liposomal bupivacaine for postoperative analgesia following anal fistula surgery, thereby generating high-level evidence to support its clinical application in this context.",[80],"Anal Fistula",[82,83,84,85],"Anal fistula","Bupivacaine liposome","Postoperative pain","Repeat dosing","2025-07-15",{"date":88,"type":89},"2025-07-23","ACTUAL",{"date":91,"type":74},"2025-07-16",{"date":93,"type":74},"2027-06-30",{"name":5,"class":6},1]