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Trial Title:
Laparoscopic TAP Block During Robotic Assisted Laparoscopic Radical Prostatectomy for Improvement in Postoperative Pain
NCT ID:
NCT05753046
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Pain, Postoperative
Conditions: Keywords:
Prostate Cancer
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Enrolling by invitation
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
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
Masking:
Double (Participant, Outcomes Assessor)
Masking description:
Patients will be sedated for the procedure and unaware of when the TAP block is
administered.
Intervention:
Intervention type:
Drug
Intervention name:
Early TAP Block
Description:
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 internal oblique and transversus
abdominis muscles for the goal of pain relief.
Arm group label:
Early TAP Block
Other name:
Initiation of procedure
Intervention type:
Drug
Intervention name:
Late TAP Block
Description:
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 internal oblique and transversus
abdominis muscles for the goal of pain relief.
Arm group label:
Late TAP Block
Other name:
Conclusion of procedure
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.
Criteria for 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 >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
Gender:
Male
Gender based:
Yes
Gender description:
Men with pathologically confirmed diagnosis of prostate cancer
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Beaumont Hospital - Royal Oak
Address:
City:
Royal Oak
Zip:
48073
Country:
United States
Start date:
February 19, 2024
Completion date:
August 2025
Lead sponsor:
Agency:
William Beaumont Hospitals
Agency class:
Other
Source:
William Beaumont Hospitals
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05753046
