[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05753046":3,"trial-entities:NCT05753046":96,"trial-summary:NCT05753046":100},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":14,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":41,"secondary_outcomes":46,"sex":69,"minimum_age":70,"maximum_age":71,"healthy_volunteers":15,"eligibility_criteria":72,"std_ages":76,"locations":79,"central_contacts":89,"overall_officials":90,"references":94,"see_also_links":95},"NCT05753046","2022-235","Laparoscopic TAP Block During Robotic Assisted Laparoscopic Radical Prostatectomy for Improvement in Postoperative Pain","Perioperative Laparoscopic Transversus Abdominis Plane Block During Robotic Assisted Laparoscopic Radical Prostatectomy for Improvement in Postoperative Pain","ENROLLING_BY_INVITATION","2029-08","2025-12","2026-04-23","2024-02-19","Corewell Health East","OTHER",false,"Determine the impact of a laparoscopic-guided transversus abdominis plane (TAP) block timing (at initiation or conclusion of procedure) on the postoperative pain experience in patients following robot assisted laparoscopic radical prostatectomy (RALP).","TAP block involves the use of a local anesthetic agent injected between the internal oblique and transversus abdominis muscles for the goal of pain relief. Often times these are performed under ultrasound guidance by the anesthesiology team preoperatively. The idea behind this is to provide a neurologic block to the sensory nerve fibers supplying the anterior abdominal wall, between the internal oblique and transversus abdominis muscles. More recently, this technique has been investigated in the setting of robot-assisted laparoscopic radical prostatectomy (RALP) with promising results. There is a lack of data comparing the benefits of the timing of TAP block, and whether performing this at the initiation versus conclusion of the case provides superior results\n\nThis is a prospective, randomized controlled trial of subjects undergoing early versus late TAP block for the management of postoperative pain following RALP. Subjects will be recruited through physician referral from private Urology offices. Potential subjects (patients scheduled for RALP procedure) will be approached by the study doctor prior to surgery, either in the study doctor's office or in the pre-operative area.\n\nSubjects who meet all the eligibility criteria will be enrolled in the study and randomized (1:1) to receive early or late surgeon performed laparoscopic TAP block. Each patient will only receive one treatment (TAP block) either at the initiation or conclusion of his procedure.\n\nFor treatment delivery, subjects will receive 60 mL of 0.25 percent ropivacaine with 4 mg of dexamethasone either at the initiation of the procedure (immediately following placement of the robotic \u002F laparoscopic camera port) or at the conclusion of the procedure (immediately proceeding removal of the robotic \u002F laparoscopic camera port). Study doctors will use laparoscopic \u002F robotic camera visual aid to confirm positioning between the internal oblique and transversus abdominis muscles for the goal of pain relief.",[19],"Prostate Cancer",[19],"INTERVENTIONAL",[23],"PHASE4",{"count":25,"type":26},94,"ESTIMATED",[28,35],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"DRUG","Early TAP Block","For treatment delivery, subjects will receive 60 mL of 0.25 percent ropivacaine with 4 mg of dexamethasone at the initiation of the procedure (immediately following placement of the robotic \u002F laparoscopic camera port). The TAP block will be performed with 15 mL 2 finger breadths subcostal at the mid-clavicular line and then 15 mL at the level of the umbilicus along the mid-axillary line on each side. Laparoscopic \u002F robotic camera will be used as a visual aid to confirm positioning between the internal oblique and transversus abdominis muscles for the goal of pain relief.",[30],[34],"Initiation of procedure",{"type":29,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"Late TAP Block","For treatment delivery, subjects will receive 60 mL of 0.25 percent ropivacaine with 4 mg of dexamethasone at the conclusion of the procedure (immediately proceeding removal of the robotic \u002F laparoscopic camera port). The TAP block will be performed with 15 mL 2 finger breadths subcostal at the mid-clavicular line and then 15 mL at the level of the umbilicus along the mid-axillary line on each side. Laparoscopic \u002F robotic camera will be used as a visual aid to confirm positioning between the internal oblique and transversus abdominis muscles for the goal of pain relief.",[36],[40],"Conclusion of procedure",[42],{"measure":43,"description":44,"timeFrame":45},"Compare laparoscopic-guided TAP block timing (at initiation \"early\" or conclusion \"late\" of procedure) on the postoperative pain levels reported in patients following robot assisted laparoscopic radical prostatectomy (RALP).","Comparison of patient reported pain scales, based on a score from 0 to 10. Where 0 is no pain and 10 is the worst pain.","24 hours after RALP",[47,51,54,57,60,63,66],{"measure":48,"description":49,"timeFrame":50},"Compare the effects of TAP Block timing on total opioid consumption","Total opioid consumption will be calculated in morphine equivalent dose (MED).","7 days after RALP with TAP Block",{"measure":52,"description":53,"timeFrame":50},"Compare the effects of TAP Block timing on hospital length of stay","Total number of days hospitalized from day of procedure to day of discharge home. Reported in number of days.",{"measure":55,"description":56,"timeFrame":50},"Compare the effects of TAP Block timing on return of bowel function","When the patient reports the occurrence of the first bowel movement following the procedure. Reported in number of days.",{"measure":58,"description":59,"timeFrame":50},"Compare the effects of TAP Block timing on postoperative nausea\u002Fvomiting","Total number of patient reported occurrences of nausea\u002Fvomiting documented in the medical record.",{"measure":61,"description":62,"timeFrame":50},"Compare the effects of TAP Block timing on ambulation","The time in hours reported after the first recorded ambulation post procedure in the medical record.",{"measure":64,"description":65,"timeFrame":50},"Compare the effects of TAP Block timing on readmission for pain","The time in days following discharge to readmission with the rationale for admission noted as pain.",{"measure":67,"description":68,"timeFrame":50},"Compare the safety and tolerability of laparoscopic TAP block.","Safety and tolerability of laparoscopic TAP Block will be assessed in relation to the incidence of adverse events reported.","MALE","18 Years",null,{"inclusion":73,"exclusion":74,"raw_text":75},[],[],"Inclusion Criteria:\n\n1. Able to read, understand, and provide written, dated, informed consent prior to screening, complete study form(s) independently, comply with study protocol, and communicate with study personnel about clinically important information.\n2. Men ≥ 18 years of age.\n3. Pathologically confirmed diagnosis of prostate cancer\n4. Scheduled for routine RALP\n\nExclusion Criteria:\n\n1. Chronic opioid use (daily for \\>3 months)\n2. Weight \\<40 kilograms\n3. Any condition that causes a lack of normal sensation to the abdomen or pelvis\n4. Current or history of any physical condition that, in the investigator's opinion, might put the subject at risk or interfere with study results interpretation",[77,78],"ADULT","OLDER_ADULT",[80],{"facility":81,"city":82,"state":83,"zip":84,"country":85,"geoPoint":86},"Corewell Health William Beaumont University Hospital","Royal Oak","Michigan","48073","United States",{"lat":87,"lon":88},42.48948,-83.14465,[],[91],{"name":92,"affiliation":81,"role":93},"S. Mohammad Jafri, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":97,"biomarkers":99},[98],"Prostate Carcinoma",[],{"nct_id":4,"found":15,"summary":71,"prompt_version":71}]