Early vs Late TAP Block for Postoperative Pain in Prostate Cancer

(TAPBlock Trial)

Enrolling by invitation at 1 trial location

Age: 18+

Sex: Male

Trial Phase: Phase 4

Sponsor: William Beaumont Hospitals

Must not be taking: Opioids

Disqualifiers: Chronic opioid use, Weight <40kg, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how the timing of a specific pain relief method, called a TAP block (a type of nerve block), affects pain after prostate cancer surgery. The TAP block numbs the abdominal area to reduce pain, and researchers aim to determine whether it is more effective at the start or end of surgery. Men diagnosed with prostate cancer and scheduled for routine robotic prostate surgery might be suitable candidates for this trial. Participants will help identify the optimal timing for pain relief, potentially enhancing recovery for future patients. As a Phase 4 trial, this research focuses on an FDA-approved treatment to understand its broader benefits for patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What is the safety track record for these treatments?

Research shows that TAP blocks, a type of numbing technique, are generally safe for managing post-surgery pain. Studies have found that TAP blocks can reduce pain and decrease the need for pain medications like opioids, which often cause unpleasant side effects. Both early and late TAP block treatments have succeeded with few complications, indicating that most people handle the treatment well without major issues. The combination of ropivacaine, a common numbing medicine, and dexamethasone, an anti-inflammatory, has been used safely in other medical settings. Since this trial is in a later phase, the treatment has already been tested in many people, suggesting it is likely safe for participants. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the Early and Late TAP Block treatments for managing postoperative pain in prostate cancer patients because they offer a new approach to pain management. Unlike traditional methods that often involve systemic painkillers like opioids, these treatments use a targeted transversus abdominis plane (TAP) block with ropivacaine and dexamethasone. This method directly numbs the nerves supplying the abdominal wall, potentially reducing the need for opioids and their associated side effects. The Early TAP Block is administered at the start of the surgery, while the Late TAP Block is given at the end, allowing researchers to explore the optimal timing for pain relief, which could improve patient comfort and recovery time.

What evidence suggests that this trial's treatments could be effective for postoperative pain in prostate cancer?

Research shows that transversus abdominis plane (TAP) blocks effectively reduce pain after surgery. Studies consistently find that TAP blocks lower pain levels and reduce the need for strong painkillers like opioids. They also decrease the use of anti-nausea medication. In this trial, participants will receive either an Early TAP Block or a Late TAP Block. Both approaches aim to provide these benefits for patients undergoing prostate surgery, helping to manage pain immediately after the procedure. This treatment has proven effective for easing post-surgery pain. ^{2 4 6 7 8}

Who Is on the Research Team?

S. Mohammad Jafri, MD

Principal Investigator

Corewell Health William Beaumont University Hospital

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am scheduled for a robotic-assisted prostate surgery.

I have been diagnosed with prostate cancer through a biopsy.

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.

Exclusion Criteria

I cannot feel normal sensations in my 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

I weigh less than 40 kilograms.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a laparoscopic TAP block either at the initiation or conclusion of the RALP procedure

1 day

1 visit (in-person)

Follow-up

Participants are monitored for postoperative pain levels, opioid consumption, and other recovery metrics

7 days

1 visit (in-person), daily monitoring

Long-term follow-up

Participants are monitored for any readmission due to pain and overall recovery

7 days

What Are the Treatments Tested in This Trial?

Interventions

• Early TAP Block
• Late TAP Block

Trial Overview 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.

How Is the Trial Designed?

Group I: Late TAP Block Experimental Treatment 1 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 Block Experimental Treatment 1 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).

Who Is Running the Clinical Trial?

William Beaumont Hospitals

Lead Sponsor

Trials

153

Recruited

113,000+

Citations

1. mdpi.com mdpi.com/2075-4426/13/12/1634

Laparoscopic versus Ultrasound-Guided Transversus ... (3) Results: Both LAP-TAP and US-TAP block groups were associated with lower pain scores postoperatively.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11675870/

The Efficacy of Transversus Abdominis Plane (TAP) Blocks ... TAP blocks have been shown to lower postoperative pain scores, decrease postoperative opioid consumption, decrease the need for anti-emetics, ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0952818025001242

Postoperative analgesic effects of combined transversus ... This study aimed to evaluate the efficacy of the combination of ultrasound-guided transversus abdominis plane block (TAPB) and a novel anterior approach of ...

4. nature.com nature.com/articles/s41598-020-60687-y

Transversus Abdominis Plane Block Reduced Early ... These results indicated that subcostal TAP block by anesthesiologists of varied level of training reduced postoperative pain immediate after RALP.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5968225/

Effect of Transversus Abdominis Plane Block on Postoperative ... Although most published trials reported that TAP block was effective for pain relief after CRS, a few studies suggested that TAP block did not offer enough ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9541353/

Impact of analgesic techniques on early quality of recovery ... Secondary outcomes were QoR‐15 at discharge, postoperative nausea and vomiting, pain scores, return of gastrointestinal function and use of rescue analgesia.

7. sciencedirect.com sciencedirect.com/science/article/pii/S1365182X21017342

Preoperative transversus abdominis plane block ... The goal of this study was to determine whether pre-surgical TAP block would result in decreased intraoperative opiate requirements during ...

8. journals.lww.com journals.lww.com/raic/fulltext/2020/07020/transversus_abdominis_plane_block_versus_simple.14.aspx

Transversus abdominis plane block versus simple... TAP block is a promising effective method for postoperative pain control after abdominal surgeries. Successful results with minimal complications were achieved ...