[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656995":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":30,"studyPopulation":31,"armGroups":32,"interventions":26,"overallOfficials":39,"centralContacts":43,"locations":49,"responsibleParty":66,"collaborators":26,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":26,"eligibilityCriteria":75,"healthyVolunteers":76,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":26,"studyType":83,"phases":26,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":51,"whyStopped":26,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Second Hospital of Shanxi Medical University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":26},[9],{"measure":10,"description":11,"timeFrame":12},"Incidence of postoperative rebound-breakthrough pain","Proportion of participants developing rebound-breakthrough pain within 48 hours after brachial plexus block.Rebound-breakthrough pain after peripheral nerve block is characterized by sudden severe pain (NRS ≥ 7) occurring within 24 hours after block resolution. It is typically burning in nature, may occur at rest or during movement, lasts more than 2 hours, and most frequently develops 12-24 hours postoperatively.","Within 48 hours after brachial plexus block",[14,17,20,23],{"measure":12,"description":15,"timeFrame":16},"Peak numerical rating scale (NRS, 0-10) score during each rebound-breakthrough pain episode. Higher score indicates more severe pain.","Within 48 hours after block",{"measure":18,"description":19,"timeFrame":16},"Onset time of first rebound-breakthrough pain","Time interval from completion of brachial plexus block to the first occurrence of rebound-breakthrough pain.",{"measure":21,"description":22,"timeFrame":16},"Frequency of rebound-breakthrough pain episodes","Total number of rebound-breakthrough pain episodes within 48 hours after brachial plexus block.",{"measure":24,"description":25,"timeFrame":16},"Duration of each rebound-breakthrough pain episode","Duration of each rebound-breakthrough pain episode that occurs within 48 hours after brachial plexus block.",null,{"allocation":26,"interventionModel":26,"interventionModelDescription":26,"primaryPurpose":26,"observationalModel":28,"timePerspective":29,"maskingInfo":26},"COHORT","CROSS_SECTIONAL","Background: Diabetes mellitus is a highly prevalent chronic disease worldwide. Diabetic peripheral neuropathy is one of its common complications, which may alter peripheral nerve function and pain perception. Brachial plexus block is widely used for upper-limb surgery. Rebound-breakthrough pain is a clinically important adverse event after peripheral nerve block, which worsens postoperative recovery and increases opioid consumption. The incidence and clinical features of this pain among patients with type 2 diabetes remain unclear.\n\nThis observational study enrolls adult patients undergoing elective upper-extremity surgery with ultrasound-guided brachial plexus block. Participants are separated into two groups: patients with type 2 diabetes mellitus and patients without diabetes. All patients receive routine clinical anesthesia with 0.375% ropivacaine for brachial plexus block without any experimental intervention. Pre-operative baseline information includes demographic data, glycosylated hemoglobin, diabetic history, and sensory threshold measurement. Post-block data including pain scores, onset and recovery time of sensory-motor block, patient-controlled analgesia usage and additional analgesic consumption are recorded.\n\nThe primary objective is to calculate the incidence of postoperative breakthrough-rebound pain. Secondary objectives cover pain severity, onset and duration of breakthrough pain, and perioperative analgesic consumption. Collected data will be summarized and analyzed to describe clinical characteristics associated with breakthrough pain.","Adult patients receiving ultrasound-guided brachial plexus block for elective upper-extremity surgery. Subjects are divided into two cohorts: patients with type 2 diabetes mellitus and non-diabetic patients. Routine clinical anesthesia management is adopted without experimental interventions.",[33,36],{"label":34,"type":26,"description":35,"interventionNames":26},"Patients with type 2 diabetes mellitus","Adult patients diagnosed with type 2 diabetes mellitus undergoing elective upper-extremity surgery with ultrasound-guided brachial plexus block. All subjects receive routine clinical anesthesia with 0.375% ropivacaine without experimental intervention.",{"label":37,"type":26,"description":38,"interventionNames":26},"Patients without diabetes mellitus","Adult non-diabetic patients undergoing elective upper-extremity surgery with ultrasound-guided brachial plexus block. All subjects receive routine clinical anesthesia with 0.375% ropivacaine without experimental intervention.",[40],{"name":41,"affiliation":5,"role":42},"Li li Wang","STUDY_DIRECTOR",[44],{"name":45,"role":46,"phone":47,"phoneExt":26,"email":48},"Wen bo Wang","CONTACT","+8618636532676","1525565253@qq.com",[50],{"facility":5,"status":51,"city":52,"state":26,"zip":26,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"RECRUITING","Taiyuan","China","CN",{"type":56,"coordinates":57},"Point",[58,59],112.56028,37.86944,{"lat":59,"lon":58},[62],{"name":63,"role":46,"phone":64,"phoneExt":26,"email":65},"Zheng Guo","+863513365790","guozheng713@yahoo.com",{"type":67,"investigatorFullName":63,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Professor","100656995","incidence-and-clinical-features-of-breakthrough-pain-after-brachial-plexus-block-in-diabetic-patients-100656995",false,"NCT07833930","Incidence and Clinical Features of Breakthrough Pain After Brachial Plexus Block in Diabetic Patients","An Observational Study on Incidence and Clinical Characteristics of Breakthrough Pain Following Brachial Plexus Block in Adult Patients With Diabetes Mellitus","Inclusion Criteria:\n\n* Aged 18 years or older\n* Undergoing elective upper-extremity surgery\n* Planned for ultrasound-guided brachial plexus block with 0.375% ropivacaine\n* Able to cooperate with pain assessment and follow-up within 48 hours after block\n* Written informed consent obtained\n\nExclusion Criteria:\n\n* Allergy or contraindication to amide-type local anesthetics\n* Pre-existing peripheral neuropathy of the affected upper limb\n* Chronic regular use of opioids before surgery\n* Coagulopathy or infection at the block puncture site\n* Cognitive dysfunction unable to complete NRS pain evaluation\n* Pregnancy or lactation\n* Incomplete clinical data expected during follow-up",true,"ALL","18 Years","80 Years",{"count":81,"type":82},216,"ESTIMATED","OBSERVATIONAL","This observational study aims to determine the incidence and clinical characteristics of rebound-breakthrough pain after ultrasound-guided brachial plexus block in adult patients with type 2 diabetes mellitus. Adult patients undergoing elective upper-extremity surgery are divided into a type 2 diabetes group and a non-diabetic control group. Baseline clinical data and pain-related outcomes are collected after nerve block. This work may provide evidence for optimizing perioperative pain management for diabetic patients receiving brachial plexus block.",[86],"Postoperative Pain",[88,89,90],"Brachial plexus block","Rebound pain","Type 2 diabetes mellitus","2026-09-17",{"date":93,"type":94},"2026-09-22","ACTUAL",{"date":96,"type":94},"2025-09-20",{"date":98,"type":82},"2026-09-20",{"name":5,"class":6},1]