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By invitation only Phase 4 NCT05753046

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

Phase 4 – monitoring after market approval
Conditions: Prostate Cancer

Sponsor: Corewell Health East

trial.available_in: БГ
Overview
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).
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.
Who can participate
Inclusion Criteria: 1. 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. 2. Men ≥ 18 years of age. 3. Pathologically confirmed diagnosis of prostate cancer 4. Scheduled for routine RALP 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
Interventions
Early TAP Block
DRUG
Late TAP Block
DRUG
Locations 1
United States (1)
Corewell Health William Beaumont University Hospital
Royal Oak , Michigan
Technical details
Status
By invitation only
Phase
Phase 4
Study type
INTERVENTIONAL
Sex
Male only
Minimum age
18 Years
Healthy volunteers
No
Start date
19.02.2024
Completion date
01.08.2029
Registry ID
NCT05753046
Source
clinicaltrials.gov
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