Laparoscopic TAP Block During Robotic Assisted Laparoscopic Radical Prostatectomy for Improvement in Postoperative Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Early TAP Block, Late TAP Block.
- Who it may be relevant to
- Registry conditions: Prostate Cancer. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Perioperative Laparoscopic Transversus Abdominis Plane Block During Robotic Assisted Laparoscopic Radical Prostatectomy for Improvement in Postoperative Pain
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).
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.
Interventions
- Drug Early TAP Block
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). The TAP block will be performed with 15 mL 2 finger breadths subcostal at the mid-clavicular line and then 15 mL at the level of the umbilicus along the mid-axillary line on each side. Laparoscopic / robotic camera will be used as a visual aid to confirm positioning between the in - Drug Late TAP Block
For treatment delivery, subjects will receive 60 mL of 0.25 percent ropivacaine with 4 mg of dexamethasone at the conclusion of the procedure (immediately proceeding removal of the robotic / laparoscopic camera port). The TAP block will be performed with 15 mL 2 finger breadths subcostal at the mid-clavicular line and then 15 mL at the level of the umbilicus along the mid-axillary line on each side. Laparoscopic / robotic camera will be used as a visual aid to confirm positioning between the int
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). [Time frame: 24 hours after RALP]
Secondary outcome measures (7)
- Compare the effects of TAP Block timing on total opioid consumption [Time frame: 7 days after RALP with TAP Block]
- Compare the effects of TAP Block timing on hospital length of stay [Time frame: 7 days after RALP with TAP Block]
- Compare the effects of TAP Block timing on return of bowel function [Time frame: 7 days after RALP with TAP Block]
- Compare the effects of TAP Block timing on postoperative nausea/vomiting [Time frame: 7 days after RALP with TAP Block]
- Compare the effects of TAP Block timing on ambulation [Time frame: 7 days after RALP with TAP Block]
- Compare the effects of TAP Block timing on readmission for pain [Time frame: 7 days after RALP with TAP Block]
- Compare the safety and tolerability of laparoscopic TAP block. [Time frame: 7 days after RALP with TAP Block]
Eligibility criteria
Inclusion criteria
- 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.
- Men ≥ 18 years of age.
- Pathologically confirmed diagnosis of prostate cancer
- Scheduled for routine RALP
Exclusion criteria
- Chronic opioid use (daily for \>3 months)
- Weight \<40 kilograms
- Any condition that causes a lack of normal sensation to the 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Other
Study locations
United States · 1 center
- Corewell Health William Beaumont University Hospital — Royal Oak
Identifiers
NCT: NCT05753046 · 2022-235