Clinical trial NCT05753046: Laparoscopic TAP Block During Robotic Assisted Laparoscopic Radical Prostatectomy for Improvement in Postoperative Pain
Official title: Perioperative Laparoscopic Transversus Abdominis Plane Block During Robotic Assisted Laparoscopic Radical Prostatectomy for Improvement in Postoperative Pain
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE4
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Lead sponsor: William Beaumont Hospitals
Sponsor class: OTHER
First posted: 2023-03-03
Enrollment: 94
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: OTHER

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).

Detailed 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.

Eligibility criteria: 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 \&amp;gt;3 months)
2. Weight \&amp;lt;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

Primary outcomes:
measure: 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).
timeFrame: 24 hours after RALP
Secondary outcomes:
measure: Compare the effects of TAP Block timing on total opioid consumption
timeFrame: 7 days after RALP with TAP Block
measure: Compare the effects of TAP Block timing on hospital length of stay
timeFrame: 7 days after RALP with TAP Block
measure: Compare the effects of TAP Block timing on return of bowel function
timeFrame: 7 days after RALP with TAP Block
measure: Compare the effects of TAP Block timing on postoperative nausea/vomiting
timeFrame: 7 days after RALP with TAP Block
measure: Compare the effects of TAP Block timing on ambulation
timeFrame: 7 days after RALP with TAP Block
measure: Compare the effects of TAP Block timing on readmission for pain
timeFrame: 7 days after RALP with TAP Block
measure: Compare the safety and tolerability of laparoscopic TAP block.
timeFrame: 7 days after RALP with TAP Block
Other outcomes:
Locations:
city: Royal Oak
country: United States
facility: Corewell Health William Beaumont University Hospital
state: Michigan
Study officials:
affiliation: Corewell Health William Beaumont University Hospital
name: S. Mohammad Jafri, MD
role: PRINCIPAL_INVESTIGATOR
References: