Trial Outcomes & Findings for Use of Perioperative Pain Blocks In Urological Surgery (NCT NCT04426500)
NCT ID: NCT04426500
Last Updated: 2024-03-12
Results Overview
Visual analog scale (VAS) is a pain rating scale, with full scale from 0 to 10, higher score indicating more pain
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
148 participants
Primary outcome timeframe
24 hours post operatively
Results posted on
2024-03-12
Participant Flow
196 patients were eligible for the study and initially randomized. A total of 143 prostatectomy patients were deemed appropriate candidates for the trial and randomized and 114 participants were then enrolled. A total of 53 partial nephrectomy patients were deemed appropriate candidates for the trial. 34 participants were randomized and then enrolled.
Participant milestones
| Measure |
Placebo/Local Anesthesia
Up to 60ml of 0.25% bupivacaine was injected directly into each of the port sites and specimen extraction site at the conclusion of the procedure prior to skin closure.
|
Ultrasound-guided Transversus Abdominus Plane (UTAP) Block
30mL of 0.25% bupivacaine administered to bilateral TAP using ultrasound guidance in prostatectomies. 40ml 0.25% aliquot bupivacaine unilateral administered in nephrectomy patients (weight based dosage permitting).
Bupivacain: Direct injection of 0.25% bupivacaine into surgical wounds
Ultrasound-guided transversus abdominus plane block: bilateral TAP using ultrasound guidance in prostatectomies
|
Robotic -Guided Transversus Abdominus Plane (RTAP) Block
30mL of 0.25% bupivacaine injected bilaterally in the TAP plane using a RTAP through the assistant port with a laparoscopic needle driver guidance in prostatectomies. 40ml 0.25% bupivacaine unilateral will be administered in nephrectomy patients (weight based dosage permitting).
Bupivacain: Direct injection of 0.25% bupivacaine into surgical wounds
Laparoscopic-guided transversus abdominus plane block: bilateral TAP using laparoscopic guidance in prostatectomies
|
|---|---|---|---|
|
Overall Study
STARTED
|
28
|
64
|
56
|
|
Overall Study
COMPLETED
|
28
|
64
|
56
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Robotic -Guided Transversus Abdominus Plane (RTAP) Block
n=56 Participants
30mL of 0.25% bupivacaine injected bilaterally in the TAP plane using a RTAP through the assistant port with a laparoscopic needle driver guidance in prostatectomies. 40ml 0.25% bupivacaine unilateral will be administered in nephrectomy patients (weight based dosage permitting).
Bupivacain: Direct injection of 0.25% bupivacaine into surgical wounds
Laparoscopic-guided transversus abdominus plane block: bilateral TAP using laparoscopic guidance in prostatectomies
|
Ultrasound-guided Transversus Abdominus Plane (UTAP) Block
n=64 Participants
30mL of 0.25% bupivacaine administered to bilateral TAP using ultrasound guidance in prostatectomies. 40ml 0.25% aliquot bupivacaine unilateral administered in nephrectomy patients (weight based dosage permitting).
Bupivacain: Direct injection of 0.25% bupivacaine into surgical wounds
Ultrasound-guided transversus abdominus plane block: bilateral TAP using ultrasound guidance in prostatectomies
|
Placebo/Local Anesthesia
n=28 Participants
Up to 60ml of 0.25% bupivacaine was injected directly into each of the port sites and specimen extraction site at the conclusion of the procedure prior to skin closure.
|
Total
n=148 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
62.1 years
STANDARD_DEVIATION 9.5 • n=56 Participants
|
63.0 years
STANDARD_DEVIATION 10.6 • n=64 Participants
|
63.7 years
STANDARD_DEVIATION 6.6 • n=28 Participants
|
62.8 years
STANDARD_DEVIATION 9.5 • n=148 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=56 Participants
|
4 Participants
n=64 Participants
|
1 Participants
n=28 Participants
|
9 Participants
n=148 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=56 Participants
|
60 Participants
n=64 Participants
|
27 Participants
n=28 Participants
|
139 Participants
n=148 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Surgical Procedure
Robotic Prostatectomy (RP)
|
43 Participants
n=56 Participants
|
51 Participants
n=64 Participants
|
20 Participants
n=28 Participants
|
114 Participants
n=148 Participants
|
|
Surgical Procedure
Robotic Partial Nephrectomy (RPN)
|
13 Participants
n=56 Participants
|
13 Participants
n=64 Participants
|
8 Participants
n=28 Participants
|
34 Participants
n=148 Participants
|
|
Body Mass Index (BMI)
|
27.0 Kg/m^2
STANDARD_DEVIATION 4.14 • n=56 Participants
|
28.6 Kg/m^2
STANDARD_DEVIATION 4.9 • n=64 Participants
|
26.6 Kg/m^2
STANDARD_DEVIATION 4.25 • n=28 Participants
|
27.5 Kg/m^2
STANDARD_DEVIATION 4.60 • n=148 Participants
|
PRIMARY outcome
Timeframe: 24 hours post operativelyVisual analog scale (VAS) is a pain rating scale, with full scale from 0 to 10, higher score indicating more pain
Outcome measures
| Measure |
Placebo/Local Anesthesia
n=28 Participants
Up to 60ml of 0.25% bupivacaine was injected directly into each of the port sites and specimen extraction site at the conclusion of the procedure prior to skin closure.
|
Ultrasound-guided Transversus Abdominus Plane (UTAP) Block
n=64 Participants
30mL of 0.25% bupivacaine administered to bilateral TAP using ultrasound guidance in prostatectomies. 40ml 0.25% aliquot bupivacaine unilateral administered in nephrectomy patients (weight based dosage permitting).
Bupivacain: Direct injection of 0.25% bupivacaine into surgical wounds
Ultrasound-guided transversus abdominus plane block: bilateral TAP using ultrasound guidance in prostatectomies
|
Robotic -Guided Transversus Abdominus Plane (RTAP) Block
n=56 Participants
30mL of 0.25% bupivacaine injected bilaterally in the TAP plane using a RTAP through the assistant port with a laparoscopic needle driver guidance in prostatectomies. 40ml 0.25% bupivacaine unilateral will be administered in nephrectomy patients (weight based dosage permitting).
Bupivacain: Direct injection of 0.25% bupivacaine into surgical wounds
Laparoscopic-guided transversus abdominus plane block: bilateral TAP using laparoscopic guidance in prostatectomies
|
|---|---|---|---|
|
Visual Analog Scale (VAS)
|
1.29 score on a scale
Standard Deviation 1.98
|
3.16 score on a scale
Standard Deviation 3.10
|
2.89 score on a scale
Standard Deviation 2.69
|
SECONDARY outcome
Timeframe: up to 420 minutesIntraoperative time taken to complete surgical blocks and operative
Outcome measures
| Measure |
Placebo/Local Anesthesia
n=28 Participants
Up to 60ml of 0.25% bupivacaine was injected directly into each of the port sites and specimen extraction site at the conclusion of the procedure prior to skin closure.
|
Ultrasound-guided Transversus Abdominus Plane (UTAP) Block
n=64 Participants
30mL of 0.25% bupivacaine administered to bilateral TAP using ultrasound guidance in prostatectomies. 40ml 0.25% aliquot bupivacaine unilateral administered in nephrectomy patients (weight based dosage permitting).
Bupivacain: Direct injection of 0.25% bupivacaine into surgical wounds
Ultrasound-guided transversus abdominus plane block: bilateral TAP using ultrasound guidance in prostatectomies
|
Robotic -Guided Transversus Abdominus Plane (RTAP) Block
n=56 Participants
30mL of 0.25% bupivacaine injected bilaterally in the TAP plane using a RTAP through the assistant port with a laparoscopic needle driver guidance in prostatectomies. 40ml 0.25% bupivacaine unilateral will be administered in nephrectomy patients (weight based dosage permitting).
Bupivacain: Direct injection of 0.25% bupivacaine into surgical wounds
Laparoscopic-guided transversus abdominus plane block: bilateral TAP using laparoscopic guidance in prostatectomies
|
|---|---|---|---|
|
Intraoperative Time and Block Time
Time Taken to Perform Block
|
2.5 minutes
Interval 1.0 to 12.0
|
6.0 minutes
Interval 0.5 to 14.0
|
2.5 minutes
Interval 0.5 to 11.0
|
|
Intraoperative Time and Block Time
Total OR Time
|
211.5 minutes
Interval 137.0 to 293.0
|
224.5 minutes
Interval 105.0 to 388.0
|
221 minutes
Interval 114.0 to 419.0
|
SECONDARY outcome
Timeframe: up to 420 minutesIntraoperative Narcotic Use in morphine equivalents
Outcome measures
| Measure |
Placebo/Local Anesthesia
n=28 Participants
Up to 60ml of 0.25% bupivacaine was injected directly into each of the port sites and specimen extraction site at the conclusion of the procedure prior to skin closure.
|
Ultrasound-guided Transversus Abdominus Plane (UTAP) Block
n=64 Participants
30mL of 0.25% bupivacaine administered to bilateral TAP using ultrasound guidance in prostatectomies. 40ml 0.25% aliquot bupivacaine unilateral administered in nephrectomy patients (weight based dosage permitting).
Bupivacain: Direct injection of 0.25% bupivacaine into surgical wounds
Ultrasound-guided transversus abdominus plane block: bilateral TAP using ultrasound guidance in prostatectomies
|
Robotic -Guided Transversus Abdominus Plane (RTAP) Block
n=56 Participants
30mL of 0.25% bupivacaine injected bilaterally in the TAP plane using a RTAP through the assistant port with a laparoscopic needle driver guidance in prostatectomies. 40ml 0.25% bupivacaine unilateral will be administered in nephrectomy patients (weight based dosage permitting).
Bupivacain: Direct injection of 0.25% bupivacaine into surgical wounds
Laparoscopic-guided transversus abdominus plane block: bilateral TAP using laparoscopic guidance in prostatectomies
|
|---|---|---|---|
|
Intraoperative Narcotic Use
|
27.0 morphine equivalents
Standard Deviation 12.6
|
24.1 morphine equivalents
Standard Deviation 12.64
|
25.5 morphine equivalents
Standard Deviation 15.2
|
SECONDARY outcome
Timeframe: up to 420 minutesIntraoperative Ketoralac Use
Outcome measures
| Measure |
Placebo/Local Anesthesia
n=28 Participants
Up to 60ml of 0.25% bupivacaine was injected directly into each of the port sites and specimen extraction site at the conclusion of the procedure prior to skin closure.
|
Ultrasound-guided Transversus Abdominus Plane (UTAP) Block
n=64 Participants
30mL of 0.25% bupivacaine administered to bilateral TAP using ultrasound guidance in prostatectomies. 40ml 0.25% aliquot bupivacaine unilateral administered in nephrectomy patients (weight based dosage permitting).
Bupivacain: Direct injection of 0.25% bupivacaine into surgical wounds
Ultrasound-guided transversus abdominus plane block: bilateral TAP using ultrasound guidance in prostatectomies
|
Robotic -Guided Transversus Abdominus Plane (RTAP) Block
n=56 Participants
30mL of 0.25% bupivacaine injected bilaterally in the TAP plane using a RTAP through the assistant port with a laparoscopic needle driver guidance in prostatectomies. 40ml 0.25% bupivacaine unilateral will be administered in nephrectomy patients (weight based dosage permitting).
Bupivacain: Direct injection of 0.25% bupivacaine into surgical wounds
Laparoscopic-guided transversus abdominus plane block: bilateral TAP using laparoscopic guidance in prostatectomies
|
|---|---|---|---|
|
Intraoperative Ketoralac Use
|
0 mg
Interval 0.0 to 30.0
|
0 mg
Interval 0.0 to 30.0
|
15 mg
Interval 0.0 to 30.0
|
SECONDARY outcome
Timeframe: 24 hours post operativelyPostoperative Narcotic Use in morphine equivalents
Outcome measures
| Measure |
Placebo/Local Anesthesia
n=28 Participants
Up to 60ml of 0.25% bupivacaine was injected directly into each of the port sites and specimen extraction site at the conclusion of the procedure prior to skin closure.
|
Ultrasound-guided Transversus Abdominus Plane (UTAP) Block
n=64 Participants
30mL of 0.25% bupivacaine administered to bilateral TAP using ultrasound guidance in prostatectomies. 40ml 0.25% aliquot bupivacaine unilateral administered in nephrectomy patients (weight based dosage permitting).
Bupivacain: Direct injection of 0.25% bupivacaine into surgical wounds
Ultrasound-guided transversus abdominus plane block: bilateral TAP using ultrasound guidance in prostatectomies
|
Robotic -Guided Transversus Abdominus Plane (RTAP) Block
n=56 Participants
30mL of 0.25% bupivacaine injected bilaterally in the TAP plane using a RTAP through the assistant port with a laparoscopic needle driver guidance in prostatectomies. 40ml 0.25% bupivacaine unilateral will be administered in nephrectomy patients (weight based dosage permitting).
Bupivacain: Direct injection of 0.25% bupivacaine into surgical wounds
Laparoscopic-guided transversus abdominus plane block: bilateral TAP using laparoscopic guidance in prostatectomies
|
|---|---|---|---|
|
Postoperative Narcotic Use
|
14.13 morphine equivalents
Interval 0.0 to 60.0
|
19.50 morphine equivalents
Interval 0.0 to 119.0
|
17 morphine equivalents
Interval 0.0 to 111.5
|
SECONDARY outcome
Timeframe: 24 hours post operativelyThe 24-hour cumulative postoperative opioid analgesic requirement was calculated using standard tables to morphine equivalents.
Outcome measures
| Measure |
Placebo/Local Anesthesia
n=28 Participants
Up to 60ml of 0.25% bupivacaine was injected directly into each of the port sites and specimen extraction site at the conclusion of the procedure prior to skin closure.
|
Ultrasound-guided Transversus Abdominus Plane (UTAP) Block
n=64 Participants
30mL of 0.25% bupivacaine administered to bilateral TAP using ultrasound guidance in prostatectomies. 40ml 0.25% aliquot bupivacaine unilateral administered in nephrectomy patients (weight based dosage permitting).
Bupivacain: Direct injection of 0.25% bupivacaine into surgical wounds
Ultrasound-guided transversus abdominus plane block: bilateral TAP using ultrasound guidance in prostatectomies
|
Robotic -Guided Transversus Abdominus Plane (RTAP) Block
n=56 Participants
30mL of 0.25% bupivacaine injected bilaterally in the TAP plane using a RTAP through the assistant port with a laparoscopic needle driver guidance in prostatectomies. 40ml 0.25% bupivacaine unilateral will be administered in nephrectomy patients (weight based dosage permitting).
Bupivacain: Direct injection of 0.25% bupivacaine into surgical wounds
Laparoscopic-guided transversus abdominus plane block: bilateral TAP using laparoscopic guidance in prostatectomies
|
|---|---|---|---|
|
Total Analgesic Medications
Acetaminophen
|
1650 mg morphine equivalents
Interval 650.0 to 5250.0
|
1650 mg morphine equivalents
Interval 0.0 to 101000.0
|
1325 mg morphine equivalents
Interval 0.0 to 9450.0
|
|
Total Analgesic Medications
Ketorlac
|
0 mg morphine equivalents
Interval 0.0 to 60.0
|
30 mg morphine equivalents
Interval 0.0 to 60.0
|
0 mg morphine equivalents
Interval 0.0 to 90.0
|
|
Total Analgesic Medications
Ondansetron
|
0 mg morphine equivalents
Interval 0.0 to 1.0
|
0 mg morphine equivalents
Interval 0.0 to 8.0
|
0 mg morphine equivalents
Interval 0.0 to 1.0
|
SECONDARY outcome
Timeframe: 2 weeksUse of antiemetic medications during the postoperative course
Outcome measures
| Measure |
Placebo/Local Anesthesia
n=28 Participants
Up to 60ml of 0.25% bupivacaine was injected directly into each of the port sites and specimen extraction site at the conclusion of the procedure prior to skin closure.
|
Ultrasound-guided Transversus Abdominus Plane (UTAP) Block
n=64 Participants
30mL of 0.25% bupivacaine administered to bilateral TAP using ultrasound guidance in prostatectomies. 40ml 0.25% aliquot bupivacaine unilateral administered in nephrectomy patients (weight based dosage permitting).
Bupivacain: Direct injection of 0.25% bupivacaine into surgical wounds
Ultrasound-guided transversus abdominus plane block: bilateral TAP using ultrasound guidance in prostatectomies
|
Robotic -Guided Transversus Abdominus Plane (RTAP) Block
n=56 Participants
30mL of 0.25% bupivacaine injected bilaterally in the TAP plane using a RTAP through the assistant port with a laparoscopic needle driver guidance in prostatectomies. 40ml 0.25% bupivacaine unilateral will be administered in nephrectomy patients (weight based dosage permitting).
Bupivacain: Direct injection of 0.25% bupivacaine into surgical wounds
Laparoscopic-guided transversus abdominus plane block: bilateral TAP using laparoscopic guidance in prostatectomies
|
|---|---|---|---|
|
The Amount of Ondansetron Use
|
0.05 mg
Standard Deviation 0.19
|
0.31 mg
Standard Deviation 1.30
|
0.29 mg
Standard Deviation 1.29
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: Data not collected.
Number of days to the return of bowel function
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 weeksPopulation: Data not collected.
Length of hospital stay from time of surgical completion to time of discharge.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 hours post operativelyPopulation: participants divided by BMI \>30 and BMI \<30
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
Outcome measures
| Measure |
Placebo/Local Anesthesia
n=28 Participants
Up to 60ml of 0.25% bupivacaine was injected directly into each of the port sites and specimen extraction site at the conclusion of the procedure prior to skin closure.
|
Ultrasound-guided Transversus Abdominus Plane (UTAP) Block
n=64 Participants
30mL of 0.25% bupivacaine administered to bilateral TAP using ultrasound guidance in prostatectomies. 40ml 0.25% aliquot bupivacaine unilateral administered in nephrectomy patients (weight based dosage permitting).
Bupivacain: Direct injection of 0.25% bupivacaine into surgical wounds
Ultrasound-guided transversus abdominus plane block: bilateral TAP using ultrasound guidance in prostatectomies
|
Robotic -Guided Transversus Abdominus Plane (RTAP) Block
n=56 Participants
30mL of 0.25% bupivacaine injected bilaterally in the TAP plane using a RTAP through the assistant port with a laparoscopic needle driver guidance in prostatectomies. 40ml 0.25% bupivacaine unilateral will be administered in nephrectomy patients (weight based dosage permitting).
Bupivacain: Direct injection of 0.25% bupivacaine into surgical wounds
Laparoscopic-guided transversus abdominus plane block: bilateral TAP using laparoscopic guidance in prostatectomies
|
|---|---|---|---|
|
VAS in Obese Patients
BMI >30
|
1.29 score on a scale
Standard Deviation 2.21
|
4.09 score on a scale
Standard Deviation 2.94
|
2.33 score on a scale
Standard Deviation 2.24
|
|
VAS in Obese Patients
BMI <30
|
1.29 score on a scale
Standard Deviation 1.95
|
2.67 score on a scale
Standard Deviation 3.11
|
3.00 score on a scale
Standard Deviation 2.75
|
SECONDARY outcome
Timeframe: 2 weeksProcedure 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).
Outcome measures
| Measure |
Placebo/Local Anesthesia
n=28 Participants
Up to 60ml of 0.25% bupivacaine was injected directly into each of the port sites and specimen extraction site at the conclusion of the procedure prior to skin closure.
|
Ultrasound-guided Transversus Abdominus Plane (UTAP) Block
n=64 Participants
30mL of 0.25% bupivacaine administered to bilateral TAP using ultrasound guidance in prostatectomies. 40ml 0.25% aliquot bupivacaine unilateral administered in nephrectomy patients (weight based dosage permitting).
Bupivacain: Direct injection of 0.25% bupivacaine into surgical wounds
Ultrasound-guided transversus abdominus plane block: bilateral TAP using ultrasound guidance in prostatectomies
|
Robotic -Guided Transversus Abdominus Plane (RTAP) Block
n=56 Participants
30mL of 0.25% bupivacaine injected bilaterally in the TAP plane using a RTAP through the assistant port with a laparoscopic needle driver guidance in prostatectomies. 40ml 0.25% bupivacaine unilateral will be administered in nephrectomy patients (weight based dosage permitting).
Bupivacain: Direct injection of 0.25% bupivacaine into surgical wounds
Laparoscopic-guided transversus abdominus plane block: bilateral TAP using laparoscopic guidance in prostatectomies
|
|---|---|---|---|
|
Number of Procedure Related Complications
|
0 events
|
0 events
|
0 events
|
Adverse Events
Placebo/Local Anesthesia
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ultrasound-guided Transversus Abdominus Plane (UTAP) Block
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Robotic -Guided Transversus Abdominus Plane (RTAP) Block
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Reza Mehrazin
Icahn School of Medicine at Mount Sinai
Phone: (212) 241-4812
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place