Mount Sinai Hospital
New York, 10029, United States
NCT Number: NCT04426500
The study team aims to prospectively compare Placebo (local administration), ultrasound-guided transversus abdominis plane (UTAP) blocks, and laparoscopic-guided transversus abdominis plane (LTAP) blocks in patients undergoing robotic surgery of the prostate and kidney. The study team expects to be able to equally efficiently administer the blocks using direct visualization and ultrasound guidance. The study team expects that a negative result would obviate the need for longer operative time by eliminating the need for the separate ultrasound guided block while a positive result would demonstrate the increased utility of preoperative ultrasound blocks in managing postoperative pain.
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All sexes
Interventional
Phase 3
New York, 10029, United States
Currently, ultrasound-guided transversus abdominis plane (UTAP) blocks (regional anesthetic blocks) are being employed for the care of urological surgery patients. Local and regional anesthesia is commonly used throughout surgical fields. However, ultrasound-guidance can be challenging, particularly in larger, obese patients. It is unknown how such techniques compare to laparoscopic-guided blockade, with respect to time to perform, learning curve, and postoperative analgesia. The transversus abdominis plane lies deep within the abdominal wall, potentially allowing for greater ease of access from a laparoscopic approach from within than the ultrasound guided percutaneous approach.
Prior randomized studies have been completed comparing UTAP and Placebo. In 2012 Hosgood et al. compared UTAP and placebo (UTAP w/ saline) in 46 live-donor laparoscopic nephrectomy patients (24 UTAP vs. 22 placebo). Pain control (measured using the 0-10 VAS scale) was greater on post-operative day (POD) 1 in patients receiving UTAP than in controls, 19 (15) vs. 37 (20) (presented as mean (SD)), respectively. A similar randomized study in 2014 compared UTAP and placebo (UTAP w/saline) in 21 hand assisted laparoscopic nephrectomy patients (10 UTAP vs. 11 placebo). The study was initially powered for 50 patients but with decreased accrual secondary to a surgeon taking a leave of absence during the study period. Pain scores were recorded using the 0-10 VAS score. Postoperatively at 24 hours (median (IQR)) UTAP patients demonstrated decreased postoperative pain than placebo patients (1 (0-2) vs. 4 (2-6)) on the VAS score, respectively.
A larger study, done in 2016, with 80 randomized patients undergoing retroperitoneal laparoscopic urologic surgery compared UTAP (40) and saline UTAP (40). Pain scores were assessed using the 0-100 VAS score scale. On POD1, UTAP group had lower pain scores (mean (SD)) of 8.4 (5.9) vs. placebo 28.3 (12.2).
The most recent study, done in 2018, examined 100 randomized patients undergoing robotic-assisted laparoscopic prostatectomies. Fifty patients were given UTAP blocks while the others received no block. A Numerical Rating Scale (assumed to range from 0-10 as not otherwise specified) was used to assess pain. Patients receiving the block at 24 hours had better pain control (mean (SD)) (1.8 (0.82) vs. 3.57 (0.64)).
While all of these studies point to potential efficacy of UTAP, no data has been published to date comparing laparoscopic administration of the TAP block (LTAP) to ultrasound guided administration. While these regional anesthetic blocks carry a theoretical risk of hematoma or damage to surrounding structures, none of the above studies report any complications with the injections.
The study team aims to prospectively compare Placebo (local administration), UTAP, and LTAP blocks in patients undergoing robotic surgery of the prostate and kidney. The study team expects to be able to equally efficiently administer the blocks using direct visualization and ultrasound guidance. The study team expects that a negative result would obviate the need for longer operative time by eliminating the need for the separate ultrasound guided block while a positive result would demonstrate the increased utility of preoperative ultrasound blocks in managing postoperative pain.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Direct injection of 0.25% bupivacaine into surgical wounds
Other names: Local anesthesia
bilateral TAP using ultrasound guidance in prostatectomies
Other names: UTAP
bilateral TAP using laparoscopic guidance in prostatectomies
Other names: LTAP
Time frame: 24 hours post operatively
Visual analog scale (VAS) is a pain rating scale, with full scale from 0 to 10, higher score indicating more pain
Time frame: up to 420 minutes
Intraoperative time taken to complete surgical blocks and operative
Time frame: up to 420 minutes
Intraoperative Narcotic Use in morphine equivalents
Time frame: up to 420 minutes
Intraoperative Ketoralac Use
Time frame: 24 hours post operatively
Postoperative Narcotic Use in morphine equivalents
Time frame: 24 hours post operatively
The 24-hour cumulative postoperative opioid analgesic requirement was calculated using standard tables to morphine equivalents.
Time frame: 2 weeks
Use of antiemetic medications during the postoperative course
Time frame: 2 weeks
Number of days to the return of bowel function
Time frame: 2 weeks
Length of hospital stay from time of surgical completion to time of discharge.
Time frame: 24 hours post operatively
24 hour postoperative pain scores recorded using the visual analog scale (VAS) in obese patients. Visual analog scale (VAS) is a pain rating scale, with full scale from 0 to 10, higher score indicating more pain. Comparison in patients with BMI >30 and BMI<30
Time frame: 2 weeks
Procedure related complications and adverse events including bleeding or injection of anesthetic intravascular was determined according to Common Terminology Criteria for Adverse Events (CTCAE v 4.0).
Icahn School of Medicine at Mount Sinai
Other
Use of Perioperative Pain Blocks In Urological Surgery: A Phase III Randomized Single Blind Single Center Three Arm Non-inferiority Trial
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