[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100456476":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":35,"centralContacts":39,"locations":46,"responsibleParty":64,"collaborators":44,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":69,"sex":75,"minAge":76,"maxAge":44,"enrollmentInfo":77,"targetDuration":44,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":48,"whyStopped":44,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Hartford Hospital","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Liposomal Bupivacaine\u002FBupivacaine HCL","EXPERIMENTAL","20mL 1.3% Exparel (266mg) + 60mL 0.25% bupivacaine (150mg) + 20mL normal saline. Total 100mL divided into 10mL syringes, 30 mL left TAP, 30mL right TAP, 20mL left rectus, 20mL right rectus.",[13,14],"Drug: Liposomal Bupivicaine\u002FBupivacaine Admixture","Drug: Bupivacaine HCL",{"label":16,"type":17,"description":18,"interventionNames":19},"Regular Bupivacaine Arm","ACTIVE_COMPARATOR","80mL 0.25% bupivacaine (200mg) + 300mcg (0.3mL) epinephrine + 5mg (0.5mL) preservative free dexamethasone + 20mL of normal saline. Total 100mL divided into 10mL syringes, 30mL left TAP, 30mL right TAP, 20mL left rectus, 20mL right rectus.",[14],[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Liposomal Bupivicaine\u002FBupivacaine Admixture","60mL of 0.25% Bupivacaine (150mg)+ 20 mL of 1.3% Exparel (266 mg)+20mL NS=100mL",[9],[27],"Bupivacaine",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Bupivacaine HCL","80mL 0.25% bupivacaine (200mg) + 300mcg (0.3mL) epinephrine + 5mg (0.5mL) preservative free dexamethasone + 20mL NS= 100mL",[9,16],[33,34],"Dexamethasone 0.5 ml (5 mg)","Epinephrine 0.1 ml",[36],{"name":37,"affiliation":5,"role":38},"Kevin Finkel, MD","PRINCIPAL_INVESTIGATOR",[40],{"name":41,"role":42,"phone":43,"phoneExt":44,"email":45},"Aseel Walker, MD","CONTACT","860-972-1778",null,"aseel.walker@hhchealth.org",[47],{"facility":5,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"RECRUITING","Hartford","Connecticut","06102","United States","US",{"type":55,"coordinates":56},"Point",[57,58],-72.68509,41.76371,{"lat":58,"lon":57},[61],{"name":62,"role":42,"phone":44,"phoneExt":44,"email":63},"Kevin J Finkel, MD","kevin.finkel@hhchealth.org",{"type":38,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":44,"oldOrganization":44},"Kevin Finkel","Director of Clinical Research - HH Department of Anesthesiology","100456476","phase-4-bilateral-tap-and-rs-blocks-using-liposomal-bupivacainebupivacaine-vs-regular-bupivacaine-in-laparoscopic-colectomy-100456476",false,"NCT05224089","Bilateral TAP and RS Blocks Using Liposomal Bupivacaine\u002FBupivacaine vs. Regular Bupivacaine in Laparoscopic Colectomy","Bilateral Mid-Abdominal Transverse Abdominis Plane and Rectus Sheath Blocks Comparing The Use of Liposomal Bupivacaine\u002FBupivacaine vs. Regular Bupivacaine in Laparoscopic Colectomy Procedures.","TAPLIP","Inclusion Criteria:\n\n* Patients scheduled for elective laparoscopic colectomy surgery to be performed by one of the 4 colorectal surgeons in the study.\n* English speaking patients\n* Patients with American Society of Anesthesiology (ASA) physical status score I- IV\n\nExclusion Criteria:\n\n1. Emergency laparoscopic colectomy surgery\n2. Patients with distant metastatic cancers (e.g. bone, lung, brain).\n3. Scheduled for multi organs resection surgery in addition to colectomy.\n4. Patients with contraindications to TAP or RS blocks including but not limited to anatomical abnormality, previous surgical intervention that limits or prevents receiving bilateral TAP blocks (e.g. surgical mesh at the site of TAP or RS block), or infection at the injection site.\n5. Current colostomies.\n6. History of allergy to local anesthetics.\n7. Coagulopathy or coagulation disorder. Also patients who are receiving antithrombotic medications as a contraindication to receiving single shot peripheral nerve blockade as per the most recent American Society of Regional Anesthesiology (ASRA) guidelines.16\n8. Weight \\\u003C 40 kg, as 40 mL of Bupivacaine 0.25%, or combination of 20 mL of bupivacaine 0.25% with 20 mL of liposomal bupivacaine is greater than the maximal dose allowed, given concern for local anesthetic toxicity.\n9. Patients who take long acting opioid medication, or on continuous opioid \\> 50 MME per day for at least 30 days within 90 days prior to surgery. Also patients who have chronic pain syndrome with a recent preoperative consultation to the chronic pain service.\n10. Patients with current substance abuse, or history of substance abuse within 3 months, this includes any illicit drugs or excessive alcohol consumption as defined 4 or more drinks per day or 8 or more drinks per week for women and 5 or more drinks per day or 15 or more drinks per week for men.15\n11. Pregnant, nursing, or planning to become pregnant during the study or within 1 month postoperatively\n12. Refusal or lack of providing the study consent","ALL","18 Years",{"count":78,"type":79},114,"ESTIMATED","INTERVENTIONAL",[82],"PHASE4","This study will be a single center, prospective triple blinded randomized controlled study, comparing the use of liposomal bupivacaine (Exparel) to regular bupivacaine with adjuncts in bilateral mid-abdominal transverse abdominis plane (TAP) blocks for patients undergoing laparoscopic colectomy procedures.",[85],"Bowel Disease",[87,88,27,89,90,91,92],"Liposomal Bupivacaine","Exparel","Laparoscopic Colectomy","Transverse Abdominis Plane Blocks (TAP)","Regional anesthesia","Rectus Sheath Block","2025-03-28",{"date":95,"type":96},"2025-04-02","ACTUAL",{"date":98,"type":96},"2022-04-27",{"date":100,"type":79},"2026-02",{"name":5,"class":6},1]