ClinicalTrials.gg
Enrolling by invitationNCT05753046TAPBlockUpdated Apr 23, 2026

Laparoscopic TAP Block During Robotic Assisted Laparoscopic Radical Prostatectomy for Improvement in Postoperative Pain

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

Phase
Phase 4
Study type
Interventional
Enrollment
94
Allocation
Randomized
Ages
18 Years and older
Sex
Male
01

Study summary

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).

Read the detailed description

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.

02

Conditions studied

  • Prostate Cancer

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Keywords

  • Prostate Cancer
03

In context

Prostatic Neoplasms

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 →

Lead sponsor

Corewell Health East is the lead sponsor of 19 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Able to read, understand, and provide written, dated, prior to screening, complete study form(s) independently, comply with study protocol, and communicate with study personnel about information.
  2. Men ≥ 18 years of age.
  3. confirmed diagnosis of prostate cancer
  4. Scheduled for routine RALP

Exclusion criteria

Exclusion Criteria:

  1. Chronic opioid use (daily for \>3 months)
  2. Weight \<40 kilograms
  3. Any condition that causes a lack of normal sensation to the abdomen or pelvis
  4. 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
Terms in these criteria, in plain language(3)

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.

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.

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.

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.

05

Study design

Phase
Phase 4
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
94 participants (estimated)

Study arms

  • Experimental
    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 / laparoscopic camera port).

    Drug: Early TAP Block

  • Experimental
    Late 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

Interventions

  • DrugEarly 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

  • DrugLate 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 / 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

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

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.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 21, 2023
First posted
Mar 3, 2023
StartActual
Feb 19, 2024
Primary completionEst.
Aug 2028
CompletionEst.
Aug 2029
Last update
Apr 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05753046
Lead sponsor
Corewell Health East
Responsible party
S Mohammad Jafri (Urologist, Corewell Health East) — Principal investigator
First posted
Mar 3, 2023
Start date
Feb 19, 2024
Primary completion
Aug 2028 (estimated)
Completion
Aug 2029 (estimated)
Last update
Apr 23, 2026

Study contacts

S. Mohammad Jafri, MD
principal investigator · Corewell Health William Beaumont University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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