[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04399707":3,"trial-entities:NCT04399707":140,"trial-summary:NCT04399707":143},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":14,"conditions":16,"keywords":20,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":42,"secondary_outcomes":47,"sex":62,"minimum_age":63,"maximum_age":14,"healthy_volunteers":64,"eligibility_criteria":65,"std_ages":81,"locations":84,"central_contacts":109,"overall_officials":115,"references":118,"see_also_links":139},"NCT04399707","2019-035","Transcutaneous Electrical Nerve Stimulation for Post-Cesarean Pain Control","RECRUITING","2021-05","2020-05","2020-05-26","2020-01-29","Hawaii Pacific Health","OTHER",null,"Purpose of study is to evaluate the efficacy of transcutaneous electrical nerve stimulation (TENS) for post-operative pain control after a cesarean delivery compared to placebo and no TENS.",[17,18,19],"Transcutaneous Electric Nerve Stimulation","Analgesia","Cesarean Section",[21,22,23],"TENS","Transcutaneous electric nerve stimulation","Cesarean analgesia","INTERVENTIONAL","TREATMENT",[27],"NA",{"count":29,"type":30},180,"ESTIMATED",[32,38],{"type":33,"name":34,"description":35,"armGroupLabels":36},"DEVICE","Transcutaneous electrical nerve stimulation (TENS) unit","Patients will be randomized to active TENS unit, placebo TENS unit, or no TENS unit",[37],"Active TENS Unit",{"type":33,"name":39,"description":35,"armGroupLabels":40},"Placebo transcutaneous electrical nerve stimulation (TENS) unit",[41],"Placebo TENS Unit",[43],{"measure":44,"description":45,"timeFrame":46},"Post-operative narcotic consumption","Total postoperative narcotic consumption (measured in morphine equivalents)","First 60 hours post-operatively",[48,52,56,59],{"measure":49,"description":50,"timeFrame":51},"Duration of hospitalization","Length of stay in hospital","From date of cesarean delivery until discharge from hospital, assessed up to 1 month",{"measure":53,"description":54,"timeFrame":55},"Pain assessed by numeric analog scale (NAS) (0-10; 0: no pain at all, 10: worst imaginable pain)","Pain scoring","On post-operative days 1, 2, 3, and day of discharge, assessed up to 1 month",{"measure":57,"description":58,"timeFrame":55},"Satisfaction with pain control assessed by NAS (0-10; 0: very dissatisfied, 10: very satisfied)","Pain control satisfaction",{"measure":60,"description":60,"timeFrame":61},"Adverse reactions to TENS unit","From date of randomization until date of discharge, assessed up to 1 month","FEMALE","18 Years",true,{"inclusion":66,"exclusion":67,"raw_text":80},[],[68,69,70,71,72,73,74,75,76,77,78,79],"Non-English speaking","Subjects with a history of chronic pain or chronic opioid use","Pre-operative use of opioids for more than 1 week in the preceding 6 months","Previous exposure to the TENS unit","Women with an allergy or contraindication to narcotics\u002FNSAIDs\u002Facetaminophen","Subjects who had a midline vertical skin incision during this operation","Subjects who did not receive intrathecal opioids at the time of their cesarean delivery","Adhesive allergies","Subjects with a pacemaker (due to the unknown effects of the TENS on the electrical activity of the heart)","Intraoperative general anesthesia","Inability to consent to the study","Postpartum tubal ligation","Inclusion Criteria:\n\n\\- Women undergoing scheduled or non-urgent cesarean section\n\nExclusion Criteria:\n\n* Non-English speaking\n* Subjects with a history of chronic pain or chronic opioid use\n* Pre-operative use of opioids for more than 1 week in the preceding 6 months\n* Previous exposure to the TENS unit\n* Women with an allergy or contraindication to narcotics\u002FNSAIDs\u002Facetaminophen\n* Subjects who had a midline vertical skin incision during this operation\n* Subjects who did not receive intrathecal opioids at the time of their cesarean delivery\n* Adhesive allergies\n* Subjects with a pacemaker (due to the unknown effects of the TENS on the electrical activity of the heart)\n* Intraoperative general anesthesia\n* Inability to consent to the study\n* Postpartum tubal ligation",[82,83],"ADULT","OLDER_ADULT",[85],{"facility":86,"status":7,"city":87,"state":88,"zip":89,"country":90,"contacts":91,"geoPoint":106},"Nicole Kurata","Honolulu","Hawaii","96826","United States",[92,96,99,102,104],{"name":86,"role":93,"phone":94,"email":95},"CONTACT","808-577-3344","nkurata@hawaii.edu",{"name":97,"role":98},"Kelly Yamasato, MD","PRINCIPAL_INVESTIGATOR",{"name":100,"role":101},"Nicole Kurata, MD","SUB_INVESTIGATOR",{"name":103,"role":101},"Bliss Kaneshiro, MD",{"name":105,"role":101},"Reema Ghatnekar, MD",{"lat":107,"lon":108},21.30694,-157.85833,[110,112],{"name":86,"role":93,"phone":111,"email":95},"(808)577-3344",{"name":113,"role":93,"email":114},"Kelly Yamasato","kyamasat@hawaii.edu",[116],{"name":113,"affiliation":117,"role":98},"Physician",[119,123,126,129,132,135],{"pmid":120,"type":121,"citation":122},"26996986","BACKGROUND","Bateman BT, Franklin JM, Bykov K, Avorn J, Shrank WH, Brennan TA, Landon JE, Rathmell JP, Huybrechts KF, Fischer MA, Choudhry NK. Persistent opioid use following cesarean delivery: patterns and predictors among opioid-naive women. Am J Obstet Gynecol. 2016 Sep;215(3):353.e1-353.e18. doi: 10.1016\u002Fj.ajog.2016.03.016. Epub 2016 Mar 17.",{"pmid":124,"type":121,"citation":125},"19158541","Desantana JM, Sluka KA, Lauretti GR. High and low frequency TENS reduce postoperative pain intensity after laparoscopic tubal ligation: a randomized controlled trial. Clin J Pain. 2009 Jan;25(1):12-9. doi: 10.1097\u002FAJP.0b013e31817d1070.",{"pmid":127,"type":121,"citation":128},"12600800","Bjordal JM, Johnson MI, Ljunggreen AE. Transcutaneous electrical nerve stimulation (TENS) can reduce postoperative analgesic consumption. A meta-analysis with assessment of optimal treatment parameters for postoperative pain. Eur J Pain. 2003;7(2):181-8. doi: 10.1016\u002FS1090-3801(02)00098-8.",{"pmid":130,"type":121,"citation":131},"26827847","Chou R, Gordon DB, de Leon-Casasola OA, Rosenberg JM, Bickler S, Brennan T, Carter T, Cassidy CL, Chittenden EH, Degenhardt E, Griffith S, Manworren R, McCarberg B, Montgomery R, Murphy J, Perkal MF, Suresh S, Sluka K, Strassels S, Thirlby R, Viscusi E, Walco GA, Warner L, Weisman SJ, Wu CL. Management of Postoperative Pain: A Clinical Practice Guideline From the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016 Feb;17(2):131-57. doi: 10.1016\u002Fj.jpain.2015.12.008.",{"pmid":133,"type":121,"citation":134},"19370680","Dowswell T, Bedwell C, Lavender T, Neilson JP. Transcutaneous electrical nerve stimulation (TENS) for pain relief in labour. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD007214. doi: 10.1002\u002F14651858.CD007214.pub2.",{"pmid":136,"type":137,"citation":138},"35852266","DERIVED","Kurata NB, Ghatnekar RJ, Mercer E, Chin JM, Kaneshiro B, Yamasato KS. Transcutaneous Electrical Nerve Stimulation for Post-Cesarean Birth Pain Control: A Randomized Controlled Trial. Obstet Gynecol. 2022 Aug 1;140(2):174-180. doi: 10.1097\u002FAOG.0000000000004798. Epub 2022 Jul 6.",[],{"nct_id":4,"conditions":141,"biomarkers":142},[19],[],{"nct_id":4,"found":64,"summary":144,"prompt_version":154},{"design":145,"status":146,"heading":147,"summary":148,"follow_up":149,"word_count":150,"commitments":151,"compensation":152,"drugs_mentioned":153},"This is an interventional study where participants are randomly assigned to one of three groups: active TENS, placebo TENS, or no TENS. It plans to enroll 180 women.","completed","Transcutaneous Electrical Nerve Stimulation for Post-Cesarean Pain","This study is looking at whether Transcutaneous Electrical Nerve Stimulation (TENS) can help control pain after a cesarean section. TENS uses a small device that sends mild electrical pulses through your skin. You would be randomly assigned to receive an active TENS unit, a placebo (inactive) TENS unit, or no TENS unit. The main goal is to see if TENS can reduce the amount of pain medication (narcotics) you need in the first 60 hours after surgery. This study is for women aged 18 and older who are having a scheduled or non-urgent cesarean section. You cannot join if you have chronic pain, have used opioids for a long time recently, or have used a TENS unit before. The study plans to enroll 180 participants, but its current status is unclear.","The primary endpoint measures narcotic consumption during the first 60 hours post-operatively.",131,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]