Trial Outcomes & Findings for TAP-patients With Robotic Assisted Lap Prostatectomy (NCT NCT01582477)
NCT ID: NCT01582477
Last Updated: 2021-06-14
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
24 participants
Primary outcome timeframe
First postsurgical administration of an opioid
Results posted on
2021-06-14
Participant Flow
Participant milestones
| Measure |
EXPAREL 20 mL
Group receiving EXPAREL 20 mL
|
EXPAREL 40 mL
Group receiving EXPAREL 40 mL
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
TAP-patients With Robotic Assisted Lap Prostatectomy
Baseline characteristics by cohort
| Measure |
EXPAREL 20 mL
n=12 Participants
Group receiving EXPAREL 20 mL
|
EXPAREL 40 mL
n=12 Participants
Group receiving EXPAREL 40 mL
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Age, Continuous
|
60.7 years
STANDARD_DEVIATION 7.24 • n=5 Participants
|
61.7 years
STANDARD_DEVIATION 7.01 • n=7 Participants
|
61.2 years
STANDARD_DEVIATION 6.99 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
12 participants
n=7 Participants
|
24 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: First postsurgical administration of an opioidPopulation: Per protocol
Outcome measures
| Measure |
EXPAREL 20 mL
n=12 Participants
Group receiving EXPAREL 20 mL
|
EXPAREL 40 mL
n=12 Participants
Group receiving EXPAREL 40 mL
|
|---|---|---|
|
The Duration of Abdominal Analgesia From Infiltration Into the TAP
|
0.39 hours
Interval 0.27 to 0.6
|
0.44 hours
Interval 0.4 to 0.58
|
SECONDARY outcome
Timeframe: 1, 2, 6, 12, 24, 48, 72, 96 hours and 10 days after TAPPopulation: Number analyzed in one or more rows differs from overall number analyzed in the instances that participant did not complete the assessment.
11-point numeric rating scale (NRS) (0-10, where 0=no pain, 10=worst possible pain)
Outcome measures
| Measure |
EXPAREL 20 mL
n=12 Participants
Group receiving EXPAREL 20 mL
|
EXPAREL 40 mL
n=12 Participants
Group receiving EXPAREL 40 mL
|
|---|---|---|
|
Subject Reported Postsurgical Pain
1 hour after TAP
|
4.4 units on a scale
Standard Deviation 2.57
|
5.3 units on a scale
Standard Deviation 2.35
|
|
Subject Reported Postsurgical Pain
2 hours after TAP
|
3.1 units on a scale
Standard Deviation 1.5
|
3.9 units on a scale
Standard Deviation 2.15
|
|
Subject Reported Postsurgical Pain
6 hours after TAP
|
2.4 units on a scale
Standard Deviation 1.57
|
3.0 units on a scale
Standard Deviation 2.10
|
|
Subject Reported Postsurgical Pain
12 hours after TAP
|
2.5 units on a scale
Standard Deviation 2.12
|
2.2 units on a scale
Standard Deviation 1.60
|
|
Subject Reported Postsurgical Pain
24 hours after TAP
|
1.8 units on a scale
Standard Deviation 1.75
|
2.5 units on a scale
Standard Deviation 1.68
|
|
Subject Reported Postsurgical Pain
48 hours after TAP
|
2.0 units on a scale
Standard Deviation 1.54
|
2.5 units on a scale
Standard Deviation 2.61
|
|
Subject Reported Postsurgical Pain
72 hours after TAP
|
1.8 units on a scale
Standard Deviation 1.64
|
1.9 units on a scale
Standard Deviation 1.83
|
|
Subject Reported Postsurgical Pain
96 hours after TAP
|
1.1 units on a scale
Standard Deviation 1.08
|
1.7 units on a scale
Standard Deviation 2.06
|
|
Subject Reported Postsurgical Pain
Day 10 after TAP
|
0.00 units on a scale
Standard Deviation 0.00
|
1.0 units on a scale
Standard Deviation 1.55
|
SECONDARY outcome
Timeframe: 1, 2, 6, 12, 24 hours after TAPPopulation: Number analyzed in one or more rows differs from overall number analyzed in the instances that participant did not complete the assessment.
11-point NRS (0-10, 0=no pain, 10=worst possible pain)
Outcome measures
| Measure |
EXPAREL 20 mL
n=12 Participants
Group receiving EXPAREL 20 mL
|
EXPAREL 40 mL
n=12 Participants
Group receiving EXPAREL 40 mL
|
|---|---|---|
|
Physician/Healthcare Professional Assessed Postsurgical Pain
1 hour after TAP
|
4.2 units on a scale
Standard Deviation 2.33
|
5.3 units on a scale
Standard Deviation 2.35
|
|
Physician/Healthcare Professional Assessed Postsurgical Pain
2 hours after TAP
|
2.9 units on a scale
Standard Deviation 1.56
|
3.9 units on a scale
Standard Deviation 2.15
|
|
Physician/Healthcare Professional Assessed Postsurgical Pain
6 hours after TAP
|
2.4 units on a scale
Standard Deviation 1.57
|
3.0 units on a scale
Standard Deviation 2.10
|
|
Physician/Healthcare Professional Assessed Postsurgical Pain
12 hours after TAP
|
2.6 units on a scale
Standard Deviation 2.07
|
2.2 units on a scale
Standard Deviation 1.33
|
|
Physician/Healthcare Professional Assessed Postsurgical Pain
24 hours after TAP
|
1.8 units on a scale
Standard Deviation 1.75
|
2.5 units on a scale
Standard Deviation 1.68
|
SECONDARY outcome
Timeframe: 48, 72, 96 hoursNumber of pills
Outcome measures
| Measure |
EXPAREL 20 mL
n=12 Participants
Group receiving EXPAREL 20 mL
|
EXPAREL 40 mL
n=12 Participants
Group receiving EXPAREL 40 mL
|
|---|---|---|
|
Total Postsurgical Oxycodone/Acetaminophen Consumption From Hospital Discharge Through Hour 96.
48 hours
|
1.9 Number of tablets
Standard Deviation 2.11
|
2.2 Number of tablets
Standard Deviation 2.12
|
|
Total Postsurgical Oxycodone/Acetaminophen Consumption From Hospital Discharge Through Hour 96.
72 hours
|
2.8 Number of tablets
Standard Deviation 3.21
|
3.4 Number of tablets
Standard Deviation 3.75
|
|
Total Postsurgical Oxycodone/Acetaminophen Consumption From Hospital Discharge Through Hour 96.
96 hours
|
3.7 Number of tablets
Standard Deviation 4.25
|
4.8 Number of tablets
Standard Deviation 5.33
|
SECONDARY outcome
Timeframe: Until hospital discharge order was written, anticipated at 24 hours.Number of subjects
Outcome measures
| Measure |
EXPAREL 20 mL
n=12 Participants
Group receiving EXPAREL 20 mL
|
EXPAREL 40 mL
n=12 Participants
Group receiving EXPAREL 40 mL
|
|---|---|---|
|
Incidence of Prespecified Opioid-related Adverse Events
|
0 Number of subjects
|
0 Number of subjects
|
SECONDARY outcome
Timeframe: 24 hours, 72 hours, and day 10Population: Number analyzed in one or more rows differs from overall number analyzed in the instances that participant did not complete the assessment.
Mean of subject satisfaction offered on a 5-point Likert scale (1 = extremely dissatisfied, 2 = dissatisfied, 3 = neither satisfied nor dissatisfied, 4 = satisfied, 5 = extremely satisfied)
Outcome measures
| Measure |
EXPAREL 20 mL
n=12 Participants
Group receiving EXPAREL 20 mL
|
EXPAREL 40 mL
n=12 Participants
Group receiving EXPAREL 40 mL
|
|---|---|---|
|
Overall Rating of Subject Satisfaction With Postsurgical Pain Control
24 hours- extremely satisfied
|
8 Participants
|
7 Participants
|
|
Overall Rating of Subject Satisfaction With Postsurgical Pain Control
24 hours- satisfied
|
4 Participants
|
5 Participants
|
|
Overall Rating of Subject Satisfaction With Postsurgical Pain Control
72 hours - satisfied
|
4 Participants
|
4 Participants
|
|
Overall Rating of Subject Satisfaction With Postsurgical Pain Control
72 hours - extremely satisfied
|
7 Participants
|
7 Participants
|
|
Overall Rating of Subject Satisfaction With Postsurgical Pain Control
Day 10 - satisfied
|
3 Participants
|
4 Participants
|
|
Overall Rating of Subject Satisfaction With Postsurgical Pain Control
Day 10- extremely satisfied
|
8 Participants
|
7 Participants
|
Adverse Events
EXPAREL 20 mL
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
EXPAREL 40 mL
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
EXPAREL 20 mL
n=12 participants at risk
Group receiving EXPAREL 20 mL
|
EXPAREL 40 mL
n=12 participants at risk
Group receiving EXPAREL 40 mL
|
|---|---|---|
|
Vascular disorders
Post-procedural Hematoma
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
|
Vascular disorders
Pulmonary Embolism
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
|
General disorders
Pyrexia
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
Other adverse events
| Measure |
EXPAREL 20 mL
n=12 participants at risk
Group receiving EXPAREL 20 mL
|
EXPAREL 40 mL
n=12 participants at risk
Group receiving EXPAREL 40 mL
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Joint Stiffness
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Joint Swelling
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place