Trial Outcomes & Findings for A Safety and Efficacy Study of SABER®-Bupivacaine for Pain Following Hernia Repair (NCT NCT00974350)
NCT ID: NCT00974350
Last Updated: 2021-05-27
Results Overview
Pain intensity on movement normalized AUC over the time period 1 to 72 hours post-surgery. Data on pain intensity were collected using a 0 to 10 NRS with scores ranging from 0 (no pain) to 10 (worst pain possible). The AUC is computed for each patient using the standard trapezoidal rule and normalised by dividing by the time interval over which it is computed. This normalisation converts the AUC to the natural pain scale (NRS 0-10) to allow for better translation of the clinical treatment effect magnitude.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
124 participants
Primary outcome timeframe
1 to 72 hours post-dose
Results posted on
2021-05-27
Participant Flow
Participant milestones
| Measure |
Group 1: SABER-Bupivacaine
2.5 mL SABER-Bupivacaine/Once
SABER-Bupivacaine: Injectable Extended Release Solution; 2.5 mL SABER-Bupivacaine(330 mg)/Once
|
Group 2: SABER-Bupivacaine
5.0 mL SABER-Bupivacaine/Once
SABER-Bupivacaine: Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine(660 mg)/Once
|
Group 3: SABER-Placebo
2.5 mL or 5.0 mL SABER-Placebo/Once
SABER-Placebo: Injectable Solution; 2.5 or 5.0 mL SABER-Placebo/Once (SABER-Placebo 2.5 mL or 5.0 mL, as randomly assigned)
|
|---|---|---|---|
|
Overall Study
STARTED
|
45
|
47
|
32
|
|
Overall Study
COMPLETED
|
42
|
47
|
31
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Safety and Efficacy Study of SABER®-Bupivacaine for Pain Following Hernia Repair
Baseline characteristics by cohort
| Measure |
Group 1: SABER-Bupivacaine
n=44 Participants
2.5 mL SABER-Bupivacaine/Once
SABER-Bupivacaine: Injectable Extended Release Solution; 2.5 mL SABER-Bupivacaine(330 mg)/Once
|
Group 2: SABER-Bupivacaine
n=47 Participants
5.0 mL SABER-Bupivacaine/Once
SABER-Bupivacaine: Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine(660 mg)/Once
|
Group 3: SABER-Placebo
n=32 Participants
2.5 mL or 5.0 mL SABER-Placebo/Once
SABER-Placebo: Injectable Solution; 2.5 or 5.0 mL SABER-Placebo/Once
|
Total
n=123 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
45.9 years
STANDARD_DEVIATION 11.82 • n=99 Participants
|
48.6 years
STANDARD_DEVIATION 13.04 • n=107 Participants
|
50.3 years
STANDARD_DEVIATION 9.26 • n=206 Participants
|
48.11 years
STANDARD_DEVIATION 11.76 • n=157 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
4 Participants
n=157 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=99 Participants
|
45 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
119 Participants
n=157 Participants
|
|
BMI
|
26.5 kg/m^2
STANDARD_DEVIATION 3.74 • n=99 Participants
|
26.3 kg/m^2
STANDARD_DEVIATION 2.92 • n=107 Participants
|
26.9 kg/m^2
STANDARD_DEVIATION 3.68 • n=206 Participants
|
26.55 kg/m^2
STANDARD_DEVIATION 3.41 • n=157 Participants
|
PRIMARY outcome
Timeframe: 1 to 72 hours post-dosePopulation: ITT population (patients with data available)
Pain intensity on movement normalized AUC over the time period 1 to 72 hours post-surgery. Data on pain intensity were collected using a 0 to 10 NRS with scores ranging from 0 (no pain) to 10 (worst pain possible). The AUC is computed for each patient using the standard trapezoidal rule and normalised by dividing by the time interval over which it is computed. This normalisation converts the AUC to the natural pain scale (NRS 0-10) to allow for better translation of the clinical treatment effect magnitude.
Outcome measures
| Measure |
Group 1: SABER-Bupivacaine
n=43 Participants
2.5 mL SABER-Bupivacaine/Once
SABER-Bupivacaine: Injectable Extended Release Solution; 2.5 mL SABER-Bupivacaine(330 mg)/Once
|
Group 2: SABER-Bupivacaine
n=47 Participants
5.0 mL SABER-Bupivacaine /Once
SABER-Bupivacaine: Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine(660 mg)/Once
|
Group 3: SABER-Placebo
n=32 Participants
2.5 mL or 5.0 mL SABER-Placebo/Once
SABER-Placebo: Injectable Solution; 2.5 or 5.0 mL SABER-Placebo/Once
|
|---|---|---|---|
|
Pain Intensity on Movement
|
3.4 score on a scale
Standard Error 0.26
|
2.7 score on a scale
Standard Error 0.25
|
3.9 score on a scale
Standard Error 0.29
|
PRIMARY outcome
Timeframe: 0 to 14 days post-dosePopulation: ITT population (patients with data available)
Outcome measures
| Measure |
Group 1: SABER-Bupivacaine
n=43 Participants
2.5 mL SABER-Bupivacaine/Once
SABER-Bupivacaine: Injectable Extended Release Solution; 2.5 mL SABER-Bupivacaine(330 mg)/Once
|
Group 2: SABER-Bupivacaine
n=47 Participants
5.0 mL SABER-Bupivacaine /Once
SABER-Bupivacaine: Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine(660 mg)/Once
|
Group 3: SABER-Placebo
n=32 Participants
2.5 mL or 5.0 mL SABER-Placebo/Once
SABER-Placebo: Injectable Solution; 2.5 or 5.0 mL SABER-Placebo/Once
|
|---|---|---|---|
|
Proportion (Percent) of Patients Using Supplemental Opioids
|
31 Participants
|
25 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: 1 to 48 hours post-dosePopulation: ITT population (patients with data available)
Pain intensity AUC over the time period of 1 to 48 hours. Data on pain intensity were collected using a 0 to 10 NRS with scores ranging from 0 (no pain) to 10 (worst pain possible). The AUC is computed for each patient using the standard trapezoidal rule and normalised by dividing by the time interval over which it is computed. This normalisation converts the AUC to the natural pain scale (NRS 0-10) to allow for better translation of the clinical treatment effect magnitude.
Outcome measures
| Measure |
Group 1: SABER-Bupivacaine
n=43 Participants
2.5 mL SABER-Bupivacaine/Once
SABER-Bupivacaine: Injectable Extended Release Solution; 2.5 mL SABER-Bupivacaine(330 mg)/Once
|
Group 2: SABER-Bupivacaine
n=47 Participants
5.0 mL SABER-Bupivacaine /Once
SABER-Bupivacaine: Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine(660 mg)/Once
|
Group 3: SABER-Placebo
n=32 Participants
2.5 mL or 5.0 mL SABER-Placebo/Once
SABER-Placebo: Injectable Solution; 2.5 or 5.0 mL SABER-Placebo/Once
|
|---|---|---|---|
|
Pain Intensity
|
3.4 score on a scale
Standard Error 0.26
|
2.8 score on a scale
Standard Error 0.26
|
4.1 score on a scale
Standard Error 0.30
|
SECONDARY outcome
Timeframe: 1 to 5 days post-dosePopulation: ITT population (patients with data available)
Modified Brief Pain Inventory -An overall assessment of treatment satisfaction was made using 6 point verbal rating scale (very dissatisfied, dissatisfied, slightly dissatisfied, slightly satisfied, satisfied, very satisfied).
Outcome measures
| Measure |
Group 1: SABER-Bupivacaine
n=42 Participants
2.5 mL SABER-Bupivacaine/Once
SABER-Bupivacaine: Injectable Extended Release Solution; 2.5 mL SABER-Bupivacaine(330 mg)/Once
|
Group 2: SABER-Bupivacaine
n=47 Participants
5.0 mL SABER-Bupivacaine /Once
SABER-Bupivacaine: Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine(660 mg)/Once
|
Group 3: SABER-Placebo
n=30 Participants
2.5 mL or 5.0 mL SABER-Placebo/Once
SABER-Placebo: Injectable Solution; 2.5 or 5.0 mL SABER-Placebo/Once
|
|---|---|---|---|
|
Treatment Satisfaction
Day 1 · Very Dissatisfied
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Treatment Satisfaction
Day 1 · Dissatisfied
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Treatment Satisfaction
Day 1 · Slightly Dissatisfied
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Treatment Satisfaction
Day 1 · Slightly Satisfied
|
2 Participants
|
4 Participants
|
4 Participants
|
|
Treatment Satisfaction
Day 1 · Satisfied
|
15 Participants
|
16 Participants
|
12 Participants
|
|
Treatment Satisfaction
Day 1 · Very Satisfied
|
21 Participants
|
21 Participants
|
11 Participants
|
|
Treatment Satisfaction
Day 2 · Very Dissatisfied
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Treatment Satisfaction
Day 2 · Dissatisfied
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Treatment Satisfaction
Day 2 · Slightly Dissatisfied
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Treatment Satisfaction
Day 2 · Slightly Satisfied
|
4 Participants
|
3 Participants
|
4 Participants
|
|
Treatment Satisfaction
Day 2 · Satisfied
|
15 Participants
|
19 Participants
|
12 Participants
|
|
Treatment Satisfaction
Day 2 · Very Satisfied
|
21 Participants
|
19 Participants
|
11 Participants
|
|
Treatment Satisfaction
Day 3 · Very Dissatisfied
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment Satisfaction
Day 3 · Dissatisfied
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment Satisfaction
Day 3 · Slightly Dissatisfied
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Treatment Satisfaction
Day 3 · Slightly Satisfied
|
3 Participants
|
2 Participants
|
2 Participants
|
|
Treatment Satisfaction
Day 3 · Satisfied
|
13 Participants
|
23 Participants
|
14 Participants
|
|
Treatment Satisfaction
Day 3 · Very Satisfied
|
26 Participants
|
20 Participants
|
11 Participants
|
|
Treatment Satisfaction
Day 4 · Very Dissatisfied
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment Satisfaction
Day 4 · Dissatisfied
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Treatment Satisfaction
Day 4 · Slightly Dissatisfied
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment Satisfaction
Day 4 · Slightly Satisfied
|
2 Participants
|
1 Participants
|
3 Participants
|
|
Treatment Satisfaction
Day 4 · Satisfied
|
18 Participants
|
21 Participants
|
12 Participants
|
|
Treatment Satisfaction
Day 4 · Very Satisfied
|
18 Participants
|
22 Participants
|
13 Participants
|
|
Treatment Satisfaction
Day 5 · Very Dissatisfied
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment Satisfaction
Day 5 · Dissatisfied
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment Satisfaction
Day 5 · Slightly Dissatisfied
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Treatment Satisfaction
Day 5 · Slightly Satisfied
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Treatment Satisfaction
Day 5 · Satisfied
|
16 Participants
|
17 Participants
|
11 Participants
|
|
Treatment Satisfaction
Day 5 · Very Satisfied
|
21 Participants
|
24 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: 0 to 14 days post-dosePopulation: ITT population (patients with data available)
Outcome measures
| Measure |
Group 1: SABER-Bupivacaine
n=43 Participants
2.5 mL SABER-Bupivacaine/Once
SABER-Bupivacaine: Injectable Extended Release Solution; 2.5 mL SABER-Bupivacaine(330 mg)/Once
|
Group 2: SABER-Bupivacaine
n=47 Participants
5.0 mL SABER-Bupivacaine /Once
SABER-Bupivacaine: Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine(660 mg)/Once
|
Group 3: SABER-Placebo
n=32 Participants
2.5 mL or 5.0 mL SABER-Placebo/Once
SABER-Placebo: Injectable Solution; 2.5 or 5.0 mL SABER-Placebo/Once
|
|---|---|---|---|
|
Supplemental Opioid Use
|
17.7 Total morphine equivalent dose (mg)
Standard Deviation 25.36
|
12.5 Total morphine equivalent dose (mg)
Standard Deviation 17.63
|
38.4 Total morphine equivalent dose (mg)
Standard Deviation 60.24
|
SECONDARY outcome
Timeframe: 1 to 5 days post-dosePopulation: ITT population (patients with data available)
In past 24 hours, pain interfered with ability to function or perform activity (0-10 numeric scale, 0=no interference)
Outcome measures
| Measure |
Group 1: SABER-Bupivacaine
n=43 Participants
2.5 mL SABER-Bupivacaine/Once
SABER-Bupivacaine: Injectable Extended Release Solution; 2.5 mL SABER-Bupivacaine(330 mg)/Once
|
Group 2: SABER-Bupivacaine
n=47 Participants
5.0 mL SABER-Bupivacaine /Once
SABER-Bupivacaine: Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine(660 mg)/Once
|
Group 3: SABER-Placebo
n=32 Participants
2.5 mL or 5.0 mL SABER-Placebo/Once
SABER-Placebo: Injectable Solution; 2.5 or 5.0 mL SABER-Placebo/Once
|
|---|---|---|---|
|
Mean Function Activities (Modified Brief Pain Inventory)
get out of bed (Day 1)
|
3.2 score on a scale
Standard Deviation 2.56
|
2.7 score on a scale
Standard Deviation 2.63
|
4.6 score on a scale
Standard Deviation 3.49
|
|
Mean Function Activities (Modified Brief Pain Inventory)
get out of bed (Day 2)
|
3.0 score on a scale
Standard Deviation 2.37
|
2.4 score on a scale
Standard Deviation 1.88
|
3.0 score on a scale
Standard Deviation 2.50
|
|
Mean Function Activities (Modified Brief Pain Inventory)
get out of bed (Day 3)
|
2.5 score on a scale
Standard Deviation 2.09
|
1.5 score on a scale
Standard Deviation 1.71
|
2.1 score on a scale
Standard Deviation 2.01
|
|
Mean Function Activities (Modified Brief Pain Inventory)
get out of bed (Day 4)
|
1.7 score on a scale
Standard Deviation 1.88
|
1.1 score on a scale
Standard Deviation 1.27
|
1.9 score on a scale
Standard Deviation 2.12
|
|
Mean Function Activities (Modified Brief Pain Inventory)
get out of bed (Day 5)
|
1.7 score on a scale
Standard Deviation 1.83
|
1.1 score on a scale
Standard Deviation 1.33
|
1.4 score on a scale
Standard Deviation 1.60
|
|
Mean Function Activities (Modified Brief Pain Inventory)
Ability to walk (Day 1)
|
3.5 score on a scale
Standard Deviation 2.76
|
2.7 score on a scale
Standard Deviation 2.74
|
3.9 score on a scale
Standard Deviation 3.14
|
|
Mean Function Activities (Modified Brief Pain Inventory)
Ability to walk (Day 2)
|
2.8 score on a scale
Standard Deviation 2.25
|
2.3 score on a scale
Standard Deviation 2.09
|
2.3 score on a scale
Standard Deviation 2.35
|
|
Mean Function Activities (Modified Brief Pain Inventory)
Ability to walk (Day 3)
|
2.5 score on a scale
Standard Deviation 2.02
|
1.4 score on a scale
Standard Deviation 1.62
|
1.5 score on a scale
Standard Deviation 1.77
|
|
Mean Function Activities (Modified Brief Pain Inventory)
Ability to walk (Day 4)
|
2.0 score on a scale
Standard Deviation 1.90
|
1.0 score on a scale
Standard Deviation 1.29
|
1.7 score on a scale
Standard Deviation 2.45
|
|
Mean Function Activities (Modified Brief Pain Inventory)
Ability to walk (Day 5)
|
1.8 score on a scale
Standard Deviation 1.89
|
1.3 score on a scale
Standard Deviation 1.47
|
1.3 score on a scale
Standard Deviation 1.46
|
|
Mean Function Activities (Modified Brief Pain Inventory)
Ability To Interact With Visitors (Day 1)
|
1.1 score on a scale
Standard Deviation 2.08
|
0.7 score on a scale
Standard Deviation 1.32
|
1.4 score on a scale
Standard Deviation 1.59
|
|
Mean Function Activities (Modified Brief Pain Inventory)
Ability To Interact With Visitors (Day 2)
|
1.0 score on a scale
Standard Deviation 1.56
|
1.0 score on a scale
Standard Deviation 1.62
|
1.1 score on a scale
Standard Deviation 1.31
|
|
Mean Function Activities (Modified Brief Pain Inventory)
Ability To Interact With Visitors (Day 3)
|
0.7 score on a scale
Standard Deviation 1.22
|
0.4 score on a scale
Standard Deviation 0.84
|
0.6 score on a scale
Standard Deviation 0.63
|
|
Mean Function Activities (Modified Brief Pain Inventory)
Ability To Interact With Visitors (Day 4)
|
0.7 score on a scale
Standard Deviation 1.33
|
0.4 score on a scale
Standard Deviation 0.73
|
0.5 score on a scale
Standard Deviation 1.21
|
|
Mean Function Activities (Modified Brief Pain Inventory)
Ability To Interact With Visitors (Day 5)
|
0.5 score on a scale
Standard Deviation 1.17
|
0.4 score on a scale
Standard Deviation 0.74
|
0.3 score on a scale
Standard Deviation 0.61
|
|
Mean Function Activities (Modified Brief Pain Inventory)
Ability To Fall Asleep (Day 1)
|
2.7 score on a scale
Standard Deviation 2.37
|
2.0 score on a scale
Standard Deviation 2.31
|
2.6 score on a scale
Standard Deviation 2.09
|
|
Mean Function Activities (Modified Brief Pain Inventory)
Ability To Fall Asleep (Day 2)
|
2.0 score on a scale
Standard Deviation 2.25
|
1.3 score on a scale
Standard Deviation 1.61
|
1.8 score on a scale
Standard Deviation 1.92
|
|
Mean Function Activities (Modified Brief Pain Inventory)
Ability To Fall Asleep (Day 3)
|
1.5 score on a scale
Standard Deviation 1.61
|
0.9 score on a scale
Standard Deviation 1.14
|
1.2 score on a scale
Standard Deviation 1.31
|
|
Mean Function Activities (Modified Brief Pain Inventory)
Ability To Fall Asleep (Day 4)
|
1.4 score on a scale
Standard Deviation 2.03
|
0.6 score on a scale
Standard Deviation 1.14
|
1.3 score on a scale
Standard Deviation 2.21
|
|
Mean Function Activities (Modified Brief Pain Inventory)
Ability To Fall Asleep (Day 5)
|
1.1 score on a scale
Standard Deviation 1.52
|
0.5 score on a scale
Standard Deviation 0.74
|
0.8 score on a scale
Standard Deviation 1.45
|
|
Mean Function Activities (Modified Brief Pain Inventory)
Ability To Stay Asleep (Day 1)
|
2.6 score on a scale
Standard Deviation 2.49
|
2.2 score on a scale
Standard Deviation 2.58
|
2.1 score on a scale
Standard Deviation 2.28
|
|
Mean Function Activities (Modified Brief Pain Inventory)
Ability To Stay Asleep (Day 2)
|
2.0 score on a scale
Standard Deviation 2.26
|
1.4 score on a scale
Standard Deviation 1.79
|
1.8 score on a scale
Standard Deviation 2.01
|
|
Mean Function Activities (Modified Brief Pain Inventory)
Ability To Stay Asleep (Day 3)
|
1.4 score on a scale
Standard Deviation 1.67
|
0.7 score on a scale
Standard Deviation 1.01
|
1.2 score on a scale
Standard Deviation 1.50
|
|
Mean Function Activities (Modified Brief Pain Inventory)
Ability To Stay Asleep (Day 4)
|
1.2 score on a scale
Standard Deviation 1.71
|
0.5 score on a scale
Standard Deviation 0.90
|
1.3 score on a scale
Standard Deviation 2.33
|
|
Mean Function Activities (Modified Brief Pain Inventory)
Ability To Stay Asleep (Day 5)
|
1.1 score on a scale
Standard Deviation 1.50
|
0.7 score on a scale
Standard Deviation 0.92
|
0.7 score on a scale
Standard Deviation 1.43
|
|
Mean Function Activities (Modified Brief Pain Inventory)
Ability To Eat (Day 1)
|
1.2 score on a scale
Standard Deviation 1.89
|
0.4 score on a scale
Standard Deviation 0.94
|
0.9 score on a scale
Standard Deviation 1.58
|
|
Mean Function Activities (Modified Brief Pain Inventory)
Ability To Eat (Day 2)
|
0.9 score on a scale
Standard Deviation 1.61
|
0.3 score on a scale
Standard Deviation 0.72
|
0.5 score on a scale
Standard Deviation 1.04
|
|
Mean Function Activities (Modified Brief Pain Inventory)
Ability To Eat (Day 3)
|
0.5 score on a scale
Standard Deviation 1.06
|
0.2 score on a scale
Standard Deviation 0.55
|
0.4 score on a scale
Standard Deviation 1.19
|
|
Mean Function Activities (Modified Brief Pain Inventory)
Ability To Eat (Day 4)
|
0.4 score on a scale
Standard Deviation 1.11
|
0.2 score on a scale
Standard Deviation 0.46
|
0.3 score on a scale
Standard Deviation 0.86
|
|
Mean Function Activities (Modified Brief Pain Inventory)
Ability To Eat (Day 5)
|
0.3 score on a scale
Standard Deviation 0.98
|
0.1 score on a scale
Standard Deviation 0.36
|
0.3 score on a scale
Standard Deviation 0.86
|
|
Mean Function Activities (Modified Brief Pain Inventory)
Ability To Deep Breath (Day 1)
|
1.5 score on a scale
Standard Deviation 2.51
|
0.7 score on a scale
Standard Deviation 1.27
|
1.5 score on a scale
Standard Deviation 2.32
|
|
Mean Function Activities (Modified Brief Pain Inventory)
Ability To Deep Breath (Day 2)
|
1.2 score on a scale
Standard Deviation 2.06
|
0.8 score on a scale
Standard Deviation 1.43
|
1.1 score on a scale
Standard Deviation 1.82
|
|
Mean Function Activities (Modified Brief Pain Inventory)
Ability To Deep Breath (Day 3)
|
1.4 score on a scale
Standard Deviation 2.39
|
0.5 score on a scale
Standard Deviation 1.06
|
0.7 score on a scale
Standard Deviation 1.28
|
|
Mean Function Activities (Modified Brief Pain Inventory)
Ability To Deep Breath (Day 4)
|
1.1 score on a scale
Standard Deviation 1.93
|
0.5 score on a scale
Standard Deviation 0.90
|
0.7 score on a scale
Standard Deviation 1.56
|
|
Mean Function Activities (Modified Brief Pain Inventory)
Ability To Deep Breath (Day 5)
|
0.8 score on a scale
Standard Deviation 1.86
|
0.4 score on a scale
Standard Deviation 0.86
|
0.4 score on a scale
Standard Deviation 0.69
|
|
Mean Function Activities (Modified Brief Pain Inventory)
Ability To Cough (Day 1)
|
4.4 score on a scale
Standard Deviation 3.41
|
3.8 score on a scale
Standard Deviation 3.10
|
5.7 score on a scale
Standard Deviation 3.06
|
|
Mean Function Activities (Modified Brief Pain Inventory)
Ability To Cough (Day 2)
|
4.4 score on a scale
Standard Deviation 3.10
|
3.4 score on a scale
Standard Deviation 2.61
|
5.0 score on a scale
Standard Deviation 2.99
|
|
Mean Function Activities (Modified Brief Pain Inventory)
Ability To Cough (Day 3)
|
3.9 score on a scale
Standard Deviation 3.08
|
2.9 score on a scale
Standard Deviation 2.28
|
4.5 score on a scale
Standard Deviation 3.12
|
|
Mean Function Activities (Modified Brief Pain Inventory)
Ability To Cough (Day 4)
|
3.2 score on a scale
Standard Deviation 2.76
|
2.3 score on a scale
Standard Deviation 2.02
|
3.5 score on a scale
Standard Deviation 2.97
|
|
Mean Function Activities (Modified Brief Pain Inventory)
Ability To Cough (Day 5)
|
3.0 score on a scale
Standard Deviation 2.77
|
2.2 score on a scale
Standard Deviation 1.97
|
3.1 score on a scale
Standard Deviation 2.71
|
Adverse Events
Group 1: SABER-Bupivacaine
Serious events: 3 serious events
Other events: 44 other events
Deaths: 0 deaths
Group 2: SABER-Bupivacaine
Serious events: 2 serious events
Other events: 44 other events
Deaths: 0 deaths
Group 3: SABER-Placebo
Serious events: 1 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1: SABER-Bupivacaine
n=44 participants at risk
2.5 mL SABER-Bupivacaine /Once
SABER-Bupivacaine: Injectable Extended Release Solution; 2.5 mL SABER-Bupivacaine(330 mg)/Once
|
Group 2: SABER-Bupivacaine
n=47 participants at risk
5.0 mL SABER-Bupivacaine /Once
SABER-Bupivacaine: Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine (660 mg) /Once
|
Group 3: SABER-Placebo
n=32 participants at risk
2.5 mL or 5.0 mL SABER-Placebo/Once
SABER-Placebo: Injectable Solution; 2.5 or 5.0 mL SABER-Placebo/Once
|
|---|---|---|---|
|
Cardiac disorders
Acute coronary syndrome
|
2.3%
1/44 • Through study completion, approximately 14 days
|
0.00%
0/47 • Through study completion, approximately 14 days
|
0.00%
0/32 • Through study completion, approximately 14 days
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
2.3%
1/44 • Through study completion, approximately 14 days
|
0.00%
0/47 • Through study completion, approximately 14 days
|
0.00%
0/32 • Through study completion, approximately 14 days
|
|
Nervous system disorders
Syncope
|
0.00%
0/44 • Through study completion, approximately 14 days
|
2.1%
1/47 • Through study completion, approximately 14 days
|
3.1%
1/32 • Through study completion, approximately 14 days
|
|
Nervous system disorders
Syncope vasovagal
|
2.3%
1/44 • Through study completion, approximately 14 days
|
2.1%
1/47 • Through study completion, approximately 14 days
|
0.00%
0/32 • Through study completion, approximately 14 days
|
Other adverse events
| Measure |
Group 1: SABER-Bupivacaine
n=44 participants at risk
2.5 mL SABER-Bupivacaine /Once
SABER-Bupivacaine: Injectable Extended Release Solution; 2.5 mL SABER-Bupivacaine(330 mg)/Once
|
Group 2: SABER-Bupivacaine
n=47 participants at risk
5.0 mL SABER-Bupivacaine /Once
SABER-Bupivacaine: Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine (660 mg) /Once
|
Group 3: SABER-Placebo
n=32 participants at risk
2.5 mL or 5.0 mL SABER-Placebo/Once
SABER-Placebo: Injectable Solution; 2.5 or 5.0 mL SABER-Placebo/Once
|
|---|---|---|---|
|
Cardiac disorders
Bradycardia
|
20.5%
9/44 • Through study completion, approximately 14 days
|
25.5%
12/47 • Through study completion, approximately 14 days
|
21.9%
7/32 • Through study completion, approximately 14 days
|
|
Ear and labyrinth disorders
Tinnitus
|
6.8%
3/44 • Through study completion, approximately 14 days
|
12.8%
6/47 • Through study completion, approximately 14 days
|
15.6%
5/32 • Through study completion, approximately 14 days
|
|
Gastrointestinal disorders
Constipation
|
38.6%
17/44 • Through study completion, approximately 14 days
|
27.7%
13/47 • Through study completion, approximately 14 days
|
56.2%
18/32 • Through study completion, approximately 14 days
|
|
Gastrointestinal disorders
Nausea
|
31.8%
14/44 • Through study completion, approximately 14 days
|
19.1%
9/47 • Through study completion, approximately 14 days
|
31.2%
10/32 • Through study completion, approximately 14 days
|
|
Gastrointestinal disorders
Vomiting
|
6.8%
3/44 • Through study completion, approximately 14 days
|
2.1%
1/47 • Through study completion, approximately 14 days
|
6.2%
2/32 • Through study completion, approximately 14 days
|
|
General disorders
Application site discoloration
|
22.7%
10/44 • Through study completion, approximately 14 days
|
23.4%
11/47 • Through study completion, approximately 14 days
|
18.8%
6/32 • Through study completion, approximately 14 days
|
|
General disorders
Pyrexia
|
2.3%
1/44 • Through study completion, approximately 14 days
|
4.3%
2/47 • Through study completion, approximately 14 days
|
6.2%
2/32 • Through study completion, approximately 14 days
|
|
Infections and infestations
Incision site infection
|
0.00%
0/44 • Through study completion, approximately 14 days
|
0.00%
0/47 • Through study completion, approximately 14 days
|
6.2%
2/32 • Through study completion, approximately 14 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.1%
4/44 • Through study completion, approximately 14 days
|
4.3%
2/47 • Through study completion, approximately 14 days
|
0.00%
0/32 • Through study completion, approximately 14 days
|
|
Nervous system disorders
Dizziness
|
31.8%
14/44 • Through study completion, approximately 14 days
|
23.4%
11/47 • Through study completion, approximately 14 days
|
31.2%
10/32 • Through study completion, approximately 14 days
|
|
Nervous system disorders
Dysgeusia
|
13.6%
6/44 • Through study completion, approximately 14 days
|
10.6%
5/47 • Through study completion, approximately 14 days
|
15.6%
5/32 • Through study completion, approximately 14 days
|
|
Nervous system disorders
Headache
|
25.0%
11/44 • Through study completion, approximately 14 days
|
19.1%
9/47 • Through study completion, approximately 14 days
|
21.9%
7/32 • Through study completion, approximately 14 days
|
|
Nervous system disorders
Paraesthesia
|
20.5%
9/44 • Through study completion, approximately 14 days
|
10.6%
5/47 • Through study completion, approximately 14 days
|
6.2%
2/32 • Through study completion, approximately 14 days
|
|
Nervous system disorders
Somnolence
|
45.5%
20/44 • Through study completion, approximately 14 days
|
38.3%
18/47 • Through study completion, approximately 14 days
|
50.0%
16/32 • Through study completion, approximately 14 days
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
29.5%
13/44 • Through study completion, approximately 14 days
|
23.4%
11/47 • Through study completion, approximately 14 days
|
21.9%
7/32 • Through study completion, approximately 14 days
|
|
Vascular disorders
Hypotension
|
6.8%
3/44 • Through study completion, approximately 14 days
|
4.3%
2/47 • Through study completion, approximately 14 days
|
9.4%
3/32 • Through study completion, approximately 14 days
|
|
Injury, poisoning and procedural complications
Incision site oedema
|
6.8%
3/44 • Through study completion, approximately 14 days
|
4.3%
2/47 • Through study completion, approximately 14 days
|
3.1%
1/32 • Through study completion, approximately 14 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place