Trial Outcomes & Findings for Local Infiltration Analgesia With and Without EXPAREL Following Total Knee Arthroplasty (NCT NCT02713490)
NCT ID: NCT02713490
Last Updated: 2020-12-11
Results Overview
AUC of VAS pain intensity scores from 12 to 48 hours, which represents total pain experienced from 12 to 48 hours. Visual Analog Scale (VAS) is a pain scale. The VAS was presented as a straight 10 cm line, where 0 cm is no pain and 10 cm is the worst pain possible. Patients were asked, "How much pain are you experiencing right now? Please place a vertical mark on the line below to indicate the level of pain you are experiencing right now."
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
140 participants
Primary outcome timeframe
From 12-48 hours
Results posted on
2020-12-11
Participant Flow
Participants were recruited between April 18, 2016 and February 8, 2017 at 16 sites in the United States
A total of 167 patients were screened; there were 27 screen failures, including 2 patients who were randomized in error to the EXPAREL 266 mg + bupivacaine hydrochloride (HCl) group.
Participant milestones
| Measure |
EXPAREL 266 mg + Bupivacaine HCl
Local infiltration analgesia with EXPAREL (bupivacaine liposome injectable suspension) 266 mg/20 mL admixed with bupivacaine HCl 0.5% 20 mL and expanded with 80 mL normal saline
|
Bupivacaine HCl
Local infiltration analgesia with bupivacaine HCl 0.5% 20 mL expanded with 100 mL normal saline
|
|---|---|---|
|
Overall Study
STARTED
|
71
|
69
|
|
Overall Study
COMPLETED
|
68
|
67
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
EXPAREL 266 mg + Bupivacaine HCl
Local infiltration analgesia with EXPAREL (bupivacaine liposome injectable suspension) 266 mg/20 mL admixed with bupivacaine HCl 0.5% 20 mL and expanded with 80 mL normal saline
|
Bupivacaine HCl
Local infiltration analgesia with bupivacaine HCl 0.5% 20 mL expanded with 100 mL normal saline
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
|
Overall Study
Did not receive study drug
|
1
|
0
|
|
Overall Study
Met exclusion criteria
|
0
|
1
|
Baseline Characteristics
Two patients in the EXPAREL 266 mg + bupivacaine HCl group did not have VAS measurements entered in the database.
Baseline characteristics by cohort
| Measure |
EXPAREL
n=70 Participants
Local infiltration analgesia with EXPAREL (bupivacaine liposome injectable suspension) 266 mg/20 mL admixed with bupivacaine HCl 0.5% 20 mL and expanded with 80 mL normal saline
|
Bupivacaine
n=69 Participants
Local infiltration analgesia with bupivacaine HCl 0.5% 20 mL expanded with 100 mL normal saline
|
Total
n=139 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.7 years
STANDARD_DEVIATION 8.61 • n=70 Participants
|
65.8 years
STANDARD_DEVIATION 7.21 • n=69 Participants
|
65.8 years
STANDARD_DEVIATION 7.92 • n=139 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=70 Participants
|
39 Participants
n=69 Participants
|
82 Participants
n=139 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=70 Participants
|
30 Participants
n=69 Participants
|
57 Participants
n=139 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=70 Participants
|
1 Participants
n=69 Participants
|
5 Participants
n=139 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
66 Participants
n=70 Participants
|
68 Participants
n=69 Participants
|
134 Participants
n=139 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=70 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=139 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=70 Participants
|
0 Participants
n=69 Participants
|
1 Participants
n=139 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=70 Participants
|
1 Participants
n=69 Participants
|
1 Participants
n=139 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=70 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=139 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=70 Participants
|
5 Participants
n=69 Participants
|
12 Participants
n=139 Participants
|
|
Race (NIH/OMB)
White
|
61 Participants
n=70 Participants
|
61 Participants
n=69 Participants
|
122 Participants
n=139 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=70 Participants
|
2 Participants
n=69 Participants
|
3 Participants
n=139 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=70 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=139 Participants
|
|
Region of Enrollment
United States
|
70 participants
n=70 Participants
|
69 participants
n=69 Participants
|
139 participants
n=139 Participants
|
|
Body mass index
|
32.395 kg/m^2
STANDARD_DEVIATION 5.805 • n=70 Participants
|
31.311 kg/m^2
STANDARD_DEVIATION 5.189 • n=69 Participants
|
31.857 kg/m^2
STANDARD_DEVIATION 5.515 • n=139 Participants
|
|
VAS pain score
|
1.91 cm
STANDARD_DEVIATION 2.120 • n=68 Participants • Two patients in the EXPAREL 266 mg + bupivacaine HCl group did not have VAS measurements entered in the database.
|
1.89 cm
STANDARD_DEVIATION 2.241 • n=69 Participants • Two patients in the EXPAREL 266 mg + bupivacaine HCl group did not have VAS measurements entered in the database.
|
1.90 cm
STANDARD_DEVIATION 2.174 • n=137 Participants • Two patients in the EXPAREL 266 mg + bupivacaine HCl group did not have VAS measurements entered in the database.
|
|
American Association of Anesthesiologists classification
1
|
3 Participants
n=70 Participants
|
2 Participants
n=69 Participants
|
5 Participants
n=139 Participants
|
|
American Association of Anesthesiologists classification
2
|
45 Participants
n=70 Participants
|
40 Participants
n=69 Participants
|
85 Participants
n=139 Participants
|
|
American Association of Anesthesiologists classification
3
|
22 Participants
n=70 Participants
|
27 Participants
n=69 Participants
|
49 Participants
n=139 Participants
|
|
Location of surgery
Left
|
31 Participants
n=70 Participants
|
25 Participants
n=69 Participants
|
56 Participants
n=139 Participants
|
|
Location of surgery
Right
|
39 Participants
n=70 Participants
|
44 Participants
n=69 Participants
|
83 Participants
n=139 Participants
|
PRIMARY outcome
Timeframe: From 12-48 hoursPopulation: Efficacy population: all participants who received study drug and underwent the surgery, with analysis based on randomized treatment
AUC of VAS pain intensity scores from 12 to 48 hours, which represents total pain experienced from 12 to 48 hours. Visual Analog Scale (VAS) is a pain scale. The VAS was presented as a straight 10 cm line, where 0 cm is no pain and 10 cm is the worst pain possible. Patients were asked, "How much pain are you experiencing right now? Please place a vertical mark on the line below to indicate the level of pain you are experiencing right now."
Outcome measures
| Measure |
EXPAREL
n=69 Participants
Local infiltration analgesia with EXPAREL (bupivacaine liposome injectable suspension) 266 mg/20 mL admixed with bupivacaine HCl 0.5% 20 mL and expanded with 80 mL normal saline
|
Bupivacaine
n=69 Participants
Local infiltration analgesia with bupivacaine HCl 0.5% 20 mL expanded with 100 mL normal saline
|
|---|---|---|
|
Area Under The Curve (AUC) of Visual Analog Scale (VAS) Pain Intensity Scores From 12 to 48 Hours
|
181.523 cm*hr
Standard Error 10.786
|
208.407 cm*hr
Standard Error 10.814
|
PRIMARY outcome
Timeframe: 0-48 hoursPopulation: Efficacy population: all participants who received study drug and underwent the surgery, with analysis based on randomized treatment
Total postsurgical opioid consumption (converted to oral morphine equivalents) through 48 hours
Outcome measures
| Measure |
EXPAREL
n=70 Participants
Local infiltration analgesia with EXPAREL (bupivacaine liposome injectable suspension) 266 mg/20 mL admixed with bupivacaine HCl 0.5% 20 mL and expanded with 80 mL normal saline
|
Bupivacaine
n=69 Participants
Local infiltration analgesia with bupivacaine HCl 0.5% 20 mL expanded with 100 mL normal saline
|
|---|---|---|
|
Total Postsurgical Opioid Consumption Through 48 Hours
|
16.321 mg
Standard Error 6.684
|
80.328 mg
Standard Error 33.249
|
SECONDARY outcome
Timeframe: 48 hoursPopulation: Efficacy population: all participants who received study drug and underwent the surgery, with analysis based on randomized treatment
Outcome measures
| Measure |
EXPAREL
n=70 Participants
Local infiltration analgesia with EXPAREL (bupivacaine liposome injectable suspension) 266 mg/20 mL admixed with bupivacaine HCl 0.5% 20 mL and expanded with 80 mL normal saline
|
Bupivacaine
n=69 Participants
Local infiltration analgesia with bupivacaine HCl 0.5% 20 mL expanded with 100 mL normal saline
|
|---|---|---|
|
Percentage of Opioid-free Subjects at 48 Hours
|
7 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 48 hoursPopulation: Efficacy population: all participants who received study drug and underwent the surgery, with analysis based on randomized treatment
Time to first opioid rescue was estimated from Kaplan-Meier analysis and presented as quartiles (ie, time to rescue for the first 25% / 50% / 75% of subjects within each treatment group).
Outcome measures
| Measure |
EXPAREL
n=70 Participants
Local infiltration analgesia with EXPAREL (bupivacaine liposome injectable suspension) 266 mg/20 mL admixed with bupivacaine HCl 0.5% 20 mL and expanded with 80 mL normal saline
|
Bupivacaine
n=69 Participants
Local infiltration analgesia with bupivacaine HCl 0.5% 20 mL expanded with 100 mL normal saline
|
|---|---|---|
|
Time to First Opioid Rescue in the First 48 Hours
First quartile
|
2.617 h
Interval 1.083 to 3.233
|
1.00 h
Interval 0.6 to 1.967
|
|
Time to First Opioid Rescue in the First 48 Hours
Median quartile
|
4.125 h
Interval 3.333 to 6.133
|
2.917 h
Interval 2.083 to 3.883
|
|
Time to First Opioid Rescue in the First 48 Hours
Third quartile
|
9.667 h
Interval 6.25 to 31.083
|
7.200 h
Interval 4.0 to 12.6
|
SECONDARY outcome
Timeframe: 48 hoursPopulation: Efficacy population: all participants who received study drug and underwent the surgery, with analysis based on randomized treatment
The overall benefit of analgesic score (OBAS) comprises seven questions to assess pain intensity, adverse effects, and patients' satisfaction with analgesia (eg, "Please rate your current pain at rest on a scale between 0=minimal pain and 4=maximum imaginable pain"). Overall scores ranged between 0- 28. OBAS measures patients' benefit from postoperative pain therapy. A lower composite score indicates greater benefit from the therapy.
Outcome measures
| Measure |
EXPAREL
n=70 Participants
Local infiltration analgesia with EXPAREL (bupivacaine liposome injectable suspension) 266 mg/20 mL admixed with bupivacaine HCl 0.5% 20 mL and expanded with 80 mL normal saline
|
Bupivacaine
n=69 Participants
Local infiltration analgesia with bupivacaine HCl 0.5% 20 mL expanded with 100 mL normal saline
|
|---|---|---|
|
Overall Benefit of Analgesia Score at 48 Hours
|
4.1 score on a scale
Standard Deviation 4.08
|
4.6 score on a scale
Standard Deviation 4.33
|
Adverse Events
EXPAREL
Serious events: 1 serious events
Other events: 45 other events
Deaths: 0 deaths
Bupivacaine
Serious events: 1 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
EXPAREL
n=70 participants at risk
Local infiltration analgesia with EXPAREL (bupivacaine liposome injectable suspension) 266 mg/20 mL admixed with bupivacaine HCl 0.5% 20 mL and expanded with 80 mL normal saline
|
Bupivacaine
n=69 participants at risk
Local infiltration analgesia with bupivacaine HCl 0.5% 20 mL expanded with 100 mL normal saline
|
|---|---|---|
|
Infections and infestations
Incision site cellulitis
|
1.4%
1/70 • From screening to postsurgical day 29
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. Note that 71 subjects were randomized into the EXPAREL arm, but only 70 subjects received EXPAREL.
|
0.00%
0/69 • From screening to postsurgical day 29
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. Note that 71 subjects were randomized into the EXPAREL arm, but only 70 subjects received EXPAREL.
|
|
Infections and infestations
Influenza
|
0.00%
0/70 • From screening to postsurgical day 29
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. Note that 71 subjects were randomized into the EXPAREL arm, but only 70 subjects received EXPAREL.
|
1.4%
1/69 • From screening to postsurgical day 29
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. Note that 71 subjects were randomized into the EXPAREL arm, but only 70 subjects received EXPAREL.
|
Other adverse events
| Measure |
EXPAREL
n=70 participants at risk
Local infiltration analgesia with EXPAREL (bupivacaine liposome injectable suspension) 266 mg/20 mL admixed with bupivacaine HCl 0.5% 20 mL and expanded with 80 mL normal saline
|
Bupivacaine
n=69 participants at risk
Local infiltration analgesia with bupivacaine HCl 0.5% 20 mL expanded with 100 mL normal saline
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
30.0%
21/70 • From screening to postsurgical day 29
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. Note that 71 subjects were randomized into the EXPAREL arm, but only 70 subjects received EXPAREL.
|
31.9%
22/69 • From screening to postsurgical day 29
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. Note that 71 subjects were randomized into the EXPAREL arm, but only 70 subjects received EXPAREL.
|
|
Blood and lymphatic system disorders
Anemia
|
1.4%
1/70 • From screening to postsurgical day 29
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. Note that 71 subjects were randomized into the EXPAREL arm, but only 70 subjects received EXPAREL.
|
4.3%
3/69 • From screening to postsurgical day 29
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. Note that 71 subjects were randomized into the EXPAREL arm, but only 70 subjects received EXPAREL.
|
|
Gastrointestinal disorders
Vomiting
|
7.1%
5/70 • From screening to postsurgical day 29
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. Note that 71 subjects were randomized into the EXPAREL arm, but only 70 subjects received EXPAREL.
|
7.2%
5/69 • From screening to postsurgical day 29
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. Note that 71 subjects were randomized into the EXPAREL arm, but only 70 subjects received EXPAREL.
|
|
Gastrointestinal disorders
Constipation
|
4.3%
3/70 • From screening to postsurgical day 29
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. Note that 71 subjects were randomized into the EXPAREL arm, but only 70 subjects received EXPAREL.
|
4.3%
3/69 • From screening to postsurgical day 29
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. Note that 71 subjects were randomized into the EXPAREL arm, but only 70 subjects received EXPAREL.
|
|
General disorders
Peripheral swelling
|
1.4%
1/70 • From screening to postsurgical day 29
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. Note that 71 subjects were randomized into the EXPAREL arm, but only 70 subjects received EXPAREL.
|
4.3%
3/69 • From screening to postsurgical day 29
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. Note that 71 subjects were randomized into the EXPAREL arm, but only 70 subjects received EXPAREL.
|
|
Vascular disorders
Hypotension
|
4.3%
3/70 • From screening to postsurgical day 29
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. Note that 71 subjects were randomized into the EXPAREL arm, but only 70 subjects received EXPAREL.
|
1.4%
1/69 • From screening to postsurgical day 29
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. Note that 71 subjects were randomized into the EXPAREL arm, but only 70 subjects received EXPAREL.
|
|
Injury, poisoning and procedural complications
Anemia postoperative
|
4.3%
3/70 • From screening to postsurgical day 29
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. Note that 71 subjects were randomized into the EXPAREL arm, but only 70 subjects received EXPAREL.
|
1.4%
1/69 • From screening to postsurgical day 29
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. Note that 71 subjects were randomized into the EXPAREL arm, but only 70 subjects received EXPAREL.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.7%
4/70 • From screening to postsurgical day 29
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. Note that 71 subjects were randomized into the EXPAREL arm, but only 70 subjects received EXPAREL.
|
1.4%
1/69 • From screening to postsurgical day 29
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. Note that 71 subjects were randomized into the EXPAREL arm, but only 70 subjects received EXPAREL.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.3%
3/70 • From screening to postsurgical day 29
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. Note that 71 subjects were randomized into the EXPAREL arm, but only 70 subjects received EXPAREL.
|
4.3%
3/69 • From screening to postsurgical day 29
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. Note that 71 subjects were randomized into the EXPAREL arm, but only 70 subjects received EXPAREL.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
8.6%
6/70 • From screening to postsurgical day 29
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. Note that 71 subjects were randomized into the EXPAREL arm, but only 70 subjects received EXPAREL.
|
0.00%
0/69 • From screening to postsurgical day 29
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. Note that 71 subjects were randomized into the EXPAREL arm, but only 70 subjects received EXPAREL.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
4.3%
3/70 • From screening to postsurgical day 29
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. Note that 71 subjects were randomized into the EXPAREL arm, but only 70 subjects received EXPAREL.
|
1.4%
1/69 • From screening to postsurgical day 29
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. Note that 71 subjects were randomized into the EXPAREL arm, but only 70 subjects received EXPAREL.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.4%
1/70 • From screening to postsurgical day 29
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. Note that 71 subjects were randomized into the EXPAREL arm, but only 70 subjects received EXPAREL.
|
2.9%
2/69 • From screening to postsurgical day 29
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. Note that 71 subjects were randomized into the EXPAREL arm, but only 70 subjects received EXPAREL.
|
|
Nervous system disorders
Dizziness
|
4.3%
3/70 • From screening to postsurgical day 29
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. Note that 71 subjects were randomized into the EXPAREL arm, but only 70 subjects received EXPAREL.
|
11.6%
8/69 • From screening to postsurgical day 29
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. Note that 71 subjects were randomized into the EXPAREL arm, but only 70 subjects received EXPAREL.
|
|
Psychiatric disorders
Insomnia
|
4.3%
3/70 • From screening to postsurgical day 29
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. Note that 71 subjects were randomized into the EXPAREL arm, but only 70 subjects received EXPAREL.
|
2.9%
2/69 • From screening to postsurgical day 29
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. Note that 71 subjects were randomized into the EXPAREL arm, but only 70 subjects received EXPAREL.
|
|
Psychiatric disorders
Mental status change
|
0.00%
0/70 • From screening to postsurgical day 29
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. Note that 71 subjects were randomized into the EXPAREL arm, but only 70 subjects received EXPAREL.
|
2.9%
2/69 • From screening to postsurgical day 29
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. Note that 71 subjects were randomized into the EXPAREL arm, but only 70 subjects received EXPAREL.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
4.3%
3/70 • From screening to postsurgical day 29
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. Note that 71 subjects were randomized into the EXPAREL arm, but only 70 subjects received EXPAREL.
|
0.00%
0/69 • From screening to postsurgical day 29
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. Note that 71 subjects were randomized into the EXPAREL arm, but only 70 subjects received EXPAREL.
|
|
Cardiac disorders
Bradycardia
|
2.9%
2/70 • From screening to postsurgical day 29
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. Note that 71 subjects were randomized into the EXPAREL arm, but only 70 subjects received EXPAREL.
|
1.4%
1/69 • From screening to postsurgical day 29
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. Note that 71 subjects were randomized into the EXPAREL arm, but only 70 subjects received EXPAREL.
|
|
Infections and infestations
Urinary tract infection
|
2.9%
2/70 • From screening to postsurgical day 29
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. Note that 71 subjects were randomized into the EXPAREL arm, but only 70 subjects received EXPAREL.
|
0.00%
0/69 • From screening to postsurgical day 29
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. Note that 71 subjects were randomized into the EXPAREL arm, but only 70 subjects received EXPAREL.
|
|
Investigations
Blood osmolarity decreased
|
2.9%
2/70 • From screening to postsurgical day 29
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. Note that 71 subjects were randomized into the EXPAREL arm, but only 70 subjects received EXPAREL.
|
0.00%
0/69 • From screening to postsurgical day 29
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov. Note that 71 subjects were randomized into the EXPAREL arm, but only 70 subjects received EXPAREL.
|
Additional Information
Pacira Medical Information
Pacira Pharmaceuticals, Inc.
Phone: 1-855-793-9727
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Results conducted at Site shall not be published before 1st multicenter publication by Sponsor but can proceed if there is no such publication ≤18 months after study completion/termination at all sites and all data have been received. Before submitting manuscript/materials to an outside person/entity, site shall give Sponsor 60 days to review and comment. Site shall, upon request, further delay publication/presentation for ≤120 days to allow Sponsor to protect its interests in Inventions.
- Publication restrictions are in place
Restriction type: OTHER