[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643344":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":35,"centralContacts":40,"locations":50,"responsibleParty":69,"collaborators":72,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":77,"sex":83,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":30,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":97,"overallStatus":53,"whyStopped":30,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"Federal University of Bahia","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"High-Frequency tVNS","EXPERIMENTAL","Participants will receive active transauricular vagus nerve stimulation (tVNS) at a frequency of 60-120 Hz. Stimulation will be applied bilaterally to the auricular branch of the vagus nerve for 30 minutes before anesthesia and for 30 minutes after surgery. Current intensity will be adjusted between 2 and 6 mA according to participant tolerance.",[13],"Device: Transauricular Vagus Nerve Stimulation (tVNS)",{"label":15,"type":10,"description":16,"interventionNames":17},"Low-Frequency tVNS","Participants will receive active transauricular vagus nerve stimulation (tVNS) at a frequency of 10-20 Hz. Stimulation will be applied bilaterally to the auricular branch of the vagus nerve for 30 minutes before anesthesia and for 30 minutes after surgery. Current intensity will be adjusted between 2 and 6 mA according to participant tolerance.",[13],{"label":19,"type":20,"description":21,"interventionNames":22},"Sham tVNS","SHAM_COMPARATOR","Participants will receive sham transauricular vagus nerve stimulation. The device will be positioned and activated to mimic active treatment, but stimulation will be discontinued shortly after initiation. Participants will undergo two 30-minute sessions, one before anesthesia and one after surgery, while maintaining blinding to treatment allocation.",[23],"Device: Sham Transauricular Vagus Nerve Stimulation (sham tVNS)",[25,31],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DEVICE","Transauricular Vagus Nerve Stimulation (tVNS)","Non-invasive electrical stimulation of the auricular branch of the vagus nerve applied bilaterally through ear electrodes. Stimulation is delivered before anesthesia and after surgery using predefined frequency settings.",[9,15],null,{"type":26,"name":32,"description":33,"armGroupLabels":34,"otherNames":30},"Sham Transauricular Vagus Nerve Stimulation (sham tVNS)","Sham stimulation delivered using the same device and electrode placement as active stimulation. The device is activated to mimic treatment but does not deliver therapeutic electrical stimulation.",[19],[36],{"name":37,"affiliation":38,"role":39},"Rodrigo M Vieira, MD","Botucatu Medical School, São Paulo State University (UNESP)","PRINCIPAL_INVESTIGATOR",[41,46],{"name":42,"role":43,"phone":44,"phoneExt":30,"email":45},"Rodrigo L Alves, MD, PhD","CONTACT","71 99961-9818","rlalves@ufba.br",{"name":47,"role":43,"phone":48,"phoneExt":30,"email":49},"João Paulo A de Carvalho","75 98295-3834","joaoaureliano@ufba.br",[51],{"facility":52,"status":53,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"Hospital Universitário Professor Edgard Santos, Federal University of Bahia (HUPES-UFBA)","RECRUITING","Salvador","Estado de Bahia","40170-110","Brazil","BR",{"type":60,"coordinates":61},"Point",[62,63],-38.49096,-12.97563,{"lat":63,"lon":62},[66],{"name":67,"role":43,"phone":68,"phoneExt":30,"email":49},"João Paulo A Carvalho","75982953834",{"type":39,"investigatorFullName":70,"investigatorTitle":71,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"Joao Paulo Aureliano de Carvalho","Researcher, Department of Anesthesiology and Surgery",[73],{"name":74,"class":6},"Faculdade de Medicina de Botucatu, UNESP, Botucatu, Brasil","100643344","transauricular-vagus-nerve-stimulation-frequencies-for-postoperative-pain-100643344",false,"NCT07633444","Transauricular Vagus Nerve Stimulation Frequencies for Postoperative Pain","Effects of Different Frequencies of Transauricular Vagus Nerve Stimulation on Postoperative Pain: A Randomized, Double-Blind, Sham-Controlled Trial With Preoperative and Postoperative Sessions","TVNS-PAIN","Inclusion Criteria:\n\n* Adults aged 18 to 59 years.\n* Undergoing elective abdominal or urologic surgery.\n* American Society of Anesthesiologists (ASA) physical status I-III.\n* Able and willing to provide written informed consent.\n\nExclusion Criteria:\n\n* History of neurological disorders.\n* History of psychiatric disorders.\n* Inability to understand study procedures.\n* Pregnancy.\n* Cognitive impairment.\n* Communication difficulties that interfere with study assessments.\n* Auricular dermatitis or skin lesions at the stimulation site.\n* Pre-existing cardiac arrhythmia.\n* Chronic opioid use.\n* Implanted electronic medical devices, including pacemakers.","ALL","18 Years","59 Years",{"count":87,"type":88},174,"ESTIMATED","INTERVENTIONAL",[91],"NA","The goal of this clinical trial is to learn whether different frequencies of transauricular vagus nerve stimulation (tVNS) can reduce postoperative pain and opioid consumption in adults undergoing abdominal or urologic surgery. It will also evaluate the effects of tVNS on recovery quality, autonomic function, and treatment safety. The main questions it aims to answer are:\n\nDoes transauricular vagus nerve stimulation reduce postoperative opioid consumption during the first 24 hours after surgery? Do different stimulation frequencies (high-frequency and low-frequency tVNS) produce different effects on postoperative pain and autonomic responses? Is transauricular vagus nerve stimulation safe and well tolerated in surgical patients?\n\nResearchers will compare high-frequency tVNS, low-frequency tVNS, and sham stimulation (inactive stimulation) to determine their effects on postoperative pain and opioid requirements.\n\nParticipants will:\n\nBe randomly assigned to receive high-frequency tVNS, low-frequency tVNS, or sham stimulation.\n\nReceive two 30-minute stimulation sessions, one before anesthesia and one after surgery in the post-anesthesia care unit.\n\nUndergo assessments of postoperative pain, opioid consumption, need for rescue analgesics, postoperative nausea and vomiting, heart rate changes, and quality of recovery.\n\nBe monitored for adverse events related to the intervention during the study period.\n\nA total of 174 participants will be enrolled in this single-center, randomized, double-blind, sham-controlled clinical trial.",[94,95,96],"Postoperative Pain","Postoperative Nausea and Vomiting (PONV)","Opioid Consumption, Postoperative",[94,98,99,100,101,102,103],"Transauricular Vagus Nerve Stimulation","tVNS","Neuromodulation","Opioid Consumption","Pain Management","Randomized Controlled Trial","2026-06-07",{"date":106,"type":107},"2026-06-10","ACTUAL",{"date":109,"type":88},"2026-06-01",{"date":111,"type":88},"2026-12-04",{"name":5,"class":6},1]