Trial Outcomes & Findings for Dose-Ranging Study for Prolonged Postoperative Analgesia in Subject Undergoing Total Knee Arthroplasty (NCT NCT00485693)
NCT ID: NCT00485693
Last Updated: 2022-06-28
Results Overview
The subject's pain intensity was to be assessed with activity (NRS-A) after actively flexing the involved knee to the maximum flexion point possible. The subject was asked to respond to the following question: "On a scale of 0 to 10, where 0 = no pain and 10 = worst possible pain, how much pain did you have while bending your knee?"
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
138 participants
Primary outcome timeframe
0 to 96 hours
Results posted on
2022-06-28
Participant Flow
Participant milestones
| Measure |
Bupivacaine HCl
A single dose of study drug was to be administered intraoperatively via local infiltration
|
SKY0402
A single dose of study drug was to be administered intraoperatively via local infiltration
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
104
|
|
Overall Study
COMPLETED
|
34
|
104
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dose-Ranging Study for Prolonged Postoperative Analgesia in Subject Undergoing Total Knee Arthroplasty
Baseline characteristics by cohort
| Measure |
Bupivacaine HCl
n=34 Participants
A single dose of study drug was to be administered intraoperatively via local infiltration
|
SKY0402
n=104 Participants
A single dose of study drug was to be administered intraoperatively via local infiltration
|
Total
n=138 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
|
22 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Age, Continuous
|
62.2 years
STANDARD_DEVIATION 7.2 • n=5 Participants
|
62.3 years
STANDARD_DEVIATION 7.4 • n=7 Participants
|
62.2 years
STANDARD_DEVIATION 7.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=5 Participants
|
69 participants
n=7 Participants
|
97 participants
n=5 Participants
|
|
Region of Enrollment
Czech Republic
|
6 participants
n=5 Participants
|
35 participants
n=7 Participants
|
41 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0 to 96 hoursThe subject's pain intensity was to be assessed with activity (NRS-A) after actively flexing the involved knee to the maximum flexion point possible. The subject was asked to respond to the following question: "On a scale of 0 to 10, where 0 = no pain and 10 = worst possible pain, how much pain did you have while bending your knee?"
Outcome measures
| Measure |
Bupivacaine HCl
n=34 Participants
Single administration of 150 mg bupivacaine HCl in a 60-mL injection volume (undiluted)
|
SKY0402 Low Dose
n=28 Participants
Single administration of SKY0402150 mg in a volume of 60 mL via local infiltration
|
SKY0402 Low-mid Dose
n=25 Participants
Single administration of SKY0402 300mg in a volume of 60 mL via local infiltration
|
SKY0402 High-mid Dose
n=26 Participants
Single administration of SKY0402 450 mg in a volume of 60 mL via local infiltration
|
SKY0402 High Dose
n=25 Participants
Single administration of SKY0402 600mg in a volume of 60 mL via local infiltration
|
|---|---|---|---|---|---|
|
Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) With Activity (NRS-A) Pain Intensity Scores Through Postoperative Day 4
|
20.4 Units on a scale*hours
Standard Deviation 3.9
|
20.7 Units on a scale*hours
Standard Deviation 5.4
|
19.5 Units on a scale*hours
Standard Deviation 5.3
|
18.8 Units on a scale*hours
Standard Deviation 5.3
|
19.1 Units on a scale*hours
Standard Deviation 4.4
|
SECONDARY outcome
Timeframe: Up to 30 daysOutcome measures
Outcome data not reported
Adverse Events
Bupivacaine HCl
Serious events: 3 serious events
Other events: 29 other events
Deaths: 1 deaths
SKY0402
Serious events: 5 serious events
Other events: 83 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Bupivacaine HCl
n=34 participants at risk
A single dose of study drug was to be administered intraoperatively via local infiltration
|
SKY0402
n=104 participants at risk
A single dose of study drug was to be administered intraoperatively via local infiltration
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/34
|
0.96%
1/104 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.9%
1/34 • Number of events 1
|
0.00%
0/104
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory depression
|
0.00%
0/34
|
0.96%
1/104 • Number of events 1
|
|
Infections and infestations
Bronchitis
|
2.9%
1/34 • Number of events 1
|
0.00%
0/104
|
|
Infections and infestations
Haematoma infection
|
2.9%
1/34 • Number of events 1
|
0.00%
0/104
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/34
|
0.96%
1/104 • Number of events 1
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/34
|
0.96%
1/104 • Number of events 1
|
|
Nervous system disorders
Sedation
|
0.00%
0/34
|
0.96%
1/104 • Number of events 1
|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
0/34
|
0.96%
1/104 • Number of events 1
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.00%
0/34
|
0.96%
1/104 • Number of events 1
|
Other adverse events
| Measure |
Bupivacaine HCl
n=34 participants at risk
A single dose of study drug was to be administered intraoperatively via local infiltration
|
SKY0402
n=104 participants at risk
A single dose of study drug was to be administered intraoperatively via local infiltration
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
67.6%
23/34
|
46.2%
48/104
|
|
Gastrointestinal disorders
Constipation
|
38.2%
13/34
|
34.6%
36/104
|
|
Gastrointestinal disorders
Vomiting
|
17.6%
6/34
|
15.4%
16/104
|
|
General disorders
Pyrexia
|
32.4%
11/34
|
36.5%
38/104
|
|
General disorders
Oedema peripheral
|
32.4%
11/34
|
28.8%
30/104
|
|
General disorders
Fatigue
|
11.8%
4/34
|
4.8%
5/104
|
|
Vascular disorders
Hypotension
|
35.3%
12/34
|
20.2%
21/104
|
|
Nervous system disorders
Dizziness
|
17.6%
6/34
|
12.5%
13/104
|
|
Nervous system disorders
Somnolence
|
2.9%
1/34 • Number of events 1
|
10.6%
11/104
|
|
Nervous system disorders
Headache
|
5.9%
2/34
|
4.8%
5/104
|
|
Nervous system disorders
Lethargy
|
0.00%
0/34
|
6.7%
7/104
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
20.6%
7/34
|
12.5%
13/104
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
23.5%
8/34
|
24.0%
25/104
|
|
Blood and lymphatic system disorders
Anaemia
|
17.6%
6/34
|
15.4%
16/104
|
|
Cardiac disorders
Tachycardia
|
11.8%
4/34
|
17.3%
18/104
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
8.8%
3/34
|
5.8%
6/104
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
17.6%
6/34
|
9.6%
10/104
|
|
Psychiatric disorders
Insomnia
|
14.7%
5/34
|
10.6%
11/104
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/34
|
5.8%
6/104
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
5.9%
2/34
|
3.8%
4/104
|
Additional Information
Executive Medical Director
Pacira Pharmaceuticals, Inc.
Phone: 203-837-6500
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place