[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06997016":3,"trial-entities:NCT06997016":116,"trial-summary:NCT06997016":121},{"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":16,"conditions":17,"keywords":19,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":65,"secondary_outcomes":73,"sex":83,"minimum_age":84,"maximum_age":16,"healthy_volunteers":14,"eligibility_criteria":85,"std_ages":96,"locations":99,"central_contacts":109,"overall_officials":110,"references":114,"see_also_links":115},"NCT06997016","Baylor IRB #025-220","Enhanced Recovery After Surgery (ERAS) in Live Donor Kidney Transplant Recipients","ENROLLING_BY_INVITATION","2027-06","2025-05","2026-01-27","2025-05-05","Baylor Research Institute","OTHER",false,"The goal of this interventional study is to learn if an Enhanced Recovery After Surgery (ERAS) protocol works to reduce the need for narcotic pain medications in live donor kidney transplant recipients. The main questions it aims to answer are:\n\nDoes the ERAS protocol lower the amount of opioid narcotic medication needed to manage post-surgery pain? Does the ERAS protocol help lower pain scores after surgery? Researchers will compare the ERAS protocol to previous patients where the ERAS protocol was not used to see if the ERAS protocol works to reduce post-surgery pain.\n\nParticipants will be asked to:\n\n* Drink a pre-surgery carbohydrate drink two hours before your surgery.\n* Take a pre-surgery dose of Tylenol by mouth.\n* Take a pre-surgery dose of Gabapentin by mouth.\n* The surgeon will administer a local numbing medication at the surgery site by injection during the surgery.\n* Begin walking with assistance about 12 hours after your surgery.\n* Allow the research staff to collect data about your kidney function. This data will be collected on your postoperative clinic visits, which generally occur about twice weekly for one month. This information will determine your kidney health, need for hospitalization, and side effects that may occur.",null,[18],"Postoperative Pain",[20,21,22,23,24,25],"transplantation, kidney","renal transplantation","Enhanced Postsurgical Recovery","Recovery, Enhanced Postsurgical","pain, postoperative","postsurgical pain","INTERVENTIONAL","TREATMENT",[29],"PHASE4",{"count":31,"type":32},60,"ESTIMATED",[34,40,47,54,61],{"type":35,"name":36,"description":37,"armGroupLabels":38},"DIETARY_SUPPLEMENT","pre-operative carbohydrate drink","50 g of carbohydrate drink 2 hours before surgery",[39],"Enhanced Recovery Protocol",{"type":41,"name":42,"description":43,"armGroupLabels":44,"otherNames":45},"DRUG","Acetaminophen","650mg acetaminophen 30 minutes prior to surgery",[39],[46],"tylenol",{"type":41,"name":48,"description":49,"armGroupLabels":50,"otherNames":51},"Gabapentin","300 mg gabapentin 30 minutes prior to surgery",[39],[52,53],"Neurontin","Gralise",{"type":41,"name":55,"description":56,"armGroupLabels":57,"otherNames":58},"Bupivacaine","intraoperative local anesthetic",[39],[59,60],"Marcaine","Sensorcaine",{"type":13,"name":62,"description":63,"armGroupLabels":64},"Ambulation","Assisted ambulation 12 hours after surgery",[39],[66,70],{"measure":67,"description":68,"timeFrame":69},"Numerical Rating Scale (NRS) (0-10)","Patient reported pain on a scale from 0 (no pain) to 10 (the worst possible pain)","From enrollment to the end of treatment at 30 days",{"measure":71,"description":72,"timeFrame":69},"Narcotic Use","milligram morphine equivalents (MME)",[74,77,80],{"measure":75,"description":76,"timeFrame":69},"Adverse Events","unfavorable medical occurence",{"measure":78,"description":79,"timeFrame":69},"Hospital readmission","readmission to any hospital within 30 days",{"measure":81,"description":82,"timeFrame":69},"Length of Stay","total hospital length of stay","ALL","18 Years",{"inclusion":86,"exclusion":90,"raw_text":95},[87,88,89],"Adult patients","over 18 years of age","receiving a kidney transplant from a living donor.",[91,92,93,94],"delayed gastric emptying","severe type I diabetes","allergy to interventional medications","pregnancy (this is a normal exclusion for kidney recipients)","Inclusion Criteria:\n\n* Adult patients\n* over 18 years of age\n* receiving a kidney transplant from a living donor.\n\nExclusion Criteria:\n\n* delayed gastric emptying\n* severe type I diabetes\n* allergy to interventional medications\n* pregnancy (this is a normal exclusion for kidney recipients)",[97,98],"ADULT","OLDER_ADULT",[100],{"facility":101,"city":102,"state":103,"zip":104,"country":105,"geoPoint":106},"Baylor Scott & White All Saints Medical Center","Fort Worth","Texas","76104","United States",{"lat":107,"lon":108},32.72541,-97.32085,[],[111],{"name":112,"affiliation":101,"role":113},"Richard Ruiz, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":117,"biomarkers":120},[118,119],"Kidney Transplantation","Post-Operative Pain",[],{"nct_id":4,"found":14,"summary":16,"prompt_version":16}]