94 Participants Needed

Early vs Late TAP Block for Postoperative Pain in Prostate Cancer

(TAPBlock Trial)

Recruiting at 1 trial location
Age: 18+
Sex: Male
Trial Phase: Phase 4
Sponsor: William Beaumont Hospitals
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

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).

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 data supports the effectiveness of the treatment Early TAP Block and Late TAP Block for postoperative pain in prostate cancer?

Research shows that the TAP block can help reduce pain after prostate surgery. In one study, patients who received a TAP block reported lower pain scores and needed less pain medication compared to those who did not receive the block.12345

Is the TAP block generally safe for humans?

The TAP block, used to manage pain after surgeries like prostatectomy, is generally considered safe. Studies show it can reduce pain and the need for narcotics without adding significant time to surgery.14567

How does the TAP block treatment for postoperative pain in prostate cancer differ from other treatments?

The TAP block (transversus abdominis plane block) is a unique treatment for postoperative pain management in prostate cancer surgeries because it involves an injection of anesthetic near the abdominal muscles to block pain signals, unlike traditional methods like epidurals or wound infiltration. This approach can reduce the need for opioids like morphine and may offer better pain control with fewer side effects.12345

Research Team

SM

S. Mohammad Jafri, MD

Principal Investigator

Corewell Health William Beaumont University Hospital

Eligibility Criteria

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 am a man aged 18 or older.
I have been diagnosed with prostate cancer through a biopsy.
See 1 more

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.
See 2 more

Timeline

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

Treatment Details

Interventions

  • Early TAP Block
  • Late TAP Block
Trial OverviewThe 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.
Participant Groups
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 Clinic Near You

Who Is Running the Clinical Trial?

William Beaumont Hospitals

Lead Sponsor

Trials
153
Recruited
113,000+

References

Comparison between epidural technique and mid-axillary ultrasound-guided TAP block for postoperative analgesia of laparoscopic radical prostatectomy: a quasi-randomized clinical trial. [2022]
Pain Control after Laparoscopic Radical Prostatectomy: Comparison between Unilateral Transversus Abdominis Plane Block and Wound Infiltration. [2020]
Comparison between the analgesic efficacy of transversus abdominis plane (TAP) block and placebo in open retropubic radical prostatectomy: a prospective, randomized, double-blinded study. [2022]
Clinical implications of transversus abdominis plane block (TAP-block) for robot assisted laparoscopic radical prostatectomy: A single-institute analysis. [2022]
Transversus Abdominis Plane Block Reduced Early Postoperative Pain after Robot-assisted Prostatectomy: a Randomized Controlled Trial. [2021]
Bilateral transversus abdominis plane (TAP) block with 24 hours ropivacaine infusion via TAP catheters: A randomized trial in healthy volunteers. [2022]
Use of transversus abdominis plane block to decrease pain scores and narcotic use following robot-assisted laparoscopic prostatectomy. [2021]