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Early vs Late TAP Block for Postoperative Pain in Prostate Cancer (TAPBlock Trial)
Phase 4
Waitlist Available
Led By S. Mohammad Jafri, MD
Research Sponsored by William Beaumont Hospitals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Men ≥ 18 years of age.
Pathologically confirmed diagnosis of prostate cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours after ralp
Awards & highlights
TAPBlock Trial Summary
This trial evaluates whether giving a TAP block during or after robot-assisted prostate surgery affects post-op pain.
Who is the study for?
This trial is for men over 18 with confirmed prostate cancer, who can read and understand the study forms, provide consent, and are scheduled for routine robotic-assisted surgery. It's not for those under 40 kg, using opioids daily for more than 3 months, with a high anesthesia risk score (ASA V), or lack of normal sensation in abdomen/pelvis.Check my eligibility
What is being tested?
The study tests if the timing of a TAP block—a type of numbing medication given around the abdominal muscles—either at the start or end of robotic-assisted prostate surgery affects postoperative pain levels.See study design
What are the potential side effects?
While specific side effects aren't listed here, TAP blocks may generally cause discomfort at injection site, bleeding or hematoma formation; rare risks include infection and injury to internal organs.
TAPBlock Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a man aged 18 or older.
Select...
I have been diagnosed with prostate cancer through a biopsy.
TAPBlock Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 hours after ralp
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours after ralp
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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).
Secondary outcome measures
Compare the effects of TAP Block timing on ambulation
Compare the effects of TAP Block timing on hospital length of stay
Compare the effects of TAP Block timing on postoperative nausea/vomiting
+4 moreTAPBlock Trial Design
2Treatment groups
Experimental Treatment
Group I: Late TAP BlockExperimental Treatment1 Intervention
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).
Group II: Early TAP BlockExperimental Treatment1 Intervention
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).
Find a Location
Who is running the clinical trial?
William Beaumont HospitalsLead Sponsor
149 Previous Clinical Trials
112,764 Total Patients Enrolled
7 Trials studying Prostate Cancer
2,258 Patients Enrolled for Prostate Cancer
S. Mohammad Jafri, MDPrincipal InvestigatorBeaumont Hospital Royal Oak
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am scheduled for a robotic-assisted prostate surgery.I cannot feel normal sensations in my abdomen or pelvis.I am a man aged 18 or older.I have been diagnosed with prostate cancer through a biopsy.I weigh less than 40 kilograms.You have been taking opioid medication every day for more than three months.You have a very severe medical condition.
Research Study Groups:
This trial has the following groups:- Group 1: Early TAP Block
- Group 2: Late TAP Block
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the Early TAP Block received governmental authorization?
"We rate Early TAP Block's safety as a 3 due to its Phase 4 status, indicating that it has already been approved by regulatory authorities."
Answered by AI
Is this experiment actively enrolling participants?
"Clinicaltrials.gov reveals that this clinical trial, initially published on April 1st 2023 and last edited two months later, is no longer recruiting participants. Yet, there are 1764 other active trials currently seeking eligible candidates."
Answered by AI
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