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

NCT05753046 | Enrolling By Invitation Phase 4 FDA Drug

• 1 other identifier: 2022-235
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Prostate Cancer

Keywords

Prostate Cancer

Outcome Measures

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.

  24 hours after RALP

Secondary Outcomes (7)

• Compare the effects of TAP Block timing on total opioid consumption

  7 days after RALP with TAP Block

• Compare the effects of TAP Block timing on hospital length of stay

  7 days after RALP with TAP Block

• Compare the effects of TAP Block timing on return of bowel function

  7 days after RALP with TAP Block

• Compare the effects of TAP Block timing on postoperative nausea/vomiting

  7 days after RALP with TAP Block

• Compare the effects of TAP Block timing on ambulation

  7 days after RALP with TAP Block

Study Arms (2)

Early TAP Block

EXPERIMENTAL

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

Late TAP Block

EXPERIMENTAL

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

Early TAP Block DRUG

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

Early TAP Block

Late TAP Block DRUG

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

Late TAP Block

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Men with pathologically confirmed diagnosis of prostate cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Men ≥ 18 years of age.
• Pathologically confirmed diagnosis of prostate cancer
• Scheduled for routine RALP

You may not qualify if:

• Chronic opioid use (daily for \>3 months)
• Weight \<40 kilograms
• Any condition that causes a lack of normal sensation to the abdomen or pelvis
• 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

Sponsors & Collaborators

• Corewell Health East: lead

Study Sites (1)

Corewell Health William Beaumont University Hospital

Royal Oak, Michigan, 48073, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• S. Mohammad Jafri, MD

  Corewell Health William Beaumont University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients will be sedated for the procedure and unaware of when the TAP block is administered.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Urologist

Model Details: Patients who meet all eligibility criteria will be enrolled in the study and randomized (1:1) to receive either early or late TAP block. The subject and biostatistician will be blinded to the group allocation throughout the study. Research staff responsible for obtaining consent. To maintain the blind, initial analysis of the data performed by the biostatistician will not include group assignment.

Study Record Dates

• First Submitted: February 21, 2023
• First Posted: March 3, 2023
• Study Start: February 19, 2024
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2029
• Last Updated: April 23, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)