A Phase 4 interventional study of Early TAP Block and Late TAP Block in Prostate Cancer, sponsored by Corewell Health East. Enrolling by invitation at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-23.
Sponsored by Corewell Health East · Phase 4, Interventional, and Other
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
This 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.
Subjects 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.
For 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 / laparoscopic camera port) or at the conclusion of the procedure (immediately proceeding removal of the robotic / laparoscopic camera port). Study doctors will use laparoscopic / robotic camera visual aid to confirm positioning between the internal oblique and transversus abdominis muscles for the goal of pain relief.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's planned enrollment of 94 is above the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Corewell Health East is the lead sponsor of 19 studies on the registry; 9 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 / laparoscopic camera port).
Drug: Early TAP Block
For treatment delivery, subjects will receive 60 mL of 0.25 percent ropivacaine with 4 mg of dexamethasone either at the conclusion of the procedure (immediately preceding removal of the robotic / laparoscopic camera port).
Drug: Late 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 / 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 / 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.
Also known as: Initiation of procedure
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 / 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 / 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.
Also known as: Conclusion of procedure
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.
Time frame: 24 hours after RALP
Compare the effects of TAP Block timing on total opioid consumption
Total opioid consumption will be calculated in morphine equivalent dose (MED).
Time frame: 7 days after RALP with TAP Block
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.
Time frame: 7 days after RALP with TAP Block
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.
Time frame: 7 days after RALP with TAP Block
Compare the effects of TAP Block timing on postoperative nausea/vomiting
Total number of patient reported occurrences of nausea/vomiting documented in the medical record.
Time frame: 7 days after RALP with TAP Block
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.
Time frame: 7 days after RALP with TAP Block
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.
Time frame: 7 days after RALP with TAP Block
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.
Time frame: 7 days after RALP with TAP Block
Plan to share: No
No publications or documents are linked to this record.
Started Feb 2024 (actual). Primary completion is estimated for Aug 2028, 54 months after the start.
Of 52 phase 4 interventional studies under Prostatic Neoplasms, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 67. This study's planned 54 months is above that.
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