Trial Outcomes & Findings for The Effect of EXPAREL® on Postsurgical Pain, and the Use of Narcotics (NCT NCT03290196)
NCT ID: NCT03290196
Last Updated: 2025-03-30
Results Overview
Patient reported numeric pain rating using visual analog scale (VAS) (0 = none, 10 = severe)
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
13 participants
Primary outcome timeframe
12 hours, 24 hours, 36 hours, 48 hours
Results posted on
2025-03-30
Participant Flow
Participant milestones
| Measure |
EXPAREL 1.3 % in 20 ML Injection
EXPAREL (bupivacaine liposome injectable suspension, 20 mL single use vial, 1.3% \[13.3 mg/mL\]) is a liposome injection of bupivacaine, an amide local anesthetic, indicated for single-dose infiltration into the surgical site to produce postsurgical analgesia. EXPAREL dosage is based on the following factors:
* size of surgical site
* volume required to cover the area
* individual patient factors that may impact the safety of an amide local anesthetic
* maximum doe of 266 mg (20 mL)
EXPAREL 1.3 % in 20 ML Injection: EXPAREL single shot dose given as an analgesia for arthroscopic rotator cuff repair surgery.
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|---|---|
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Overall Study
STARTED
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13
|
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Overall Study
COMPLETED
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13
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
EXPAREL 1.3 % in 20 ML Injection
n=13 Participants
EXPAREL (bupivacaine liposome injectable suspension, 20 mL single use vial, 1.3% \[13.3 mg/mL\]) is a liposome injection of bupivacaine, an amide local anesthetic, indicated for single-dose infiltration into the surgical site to produce postsurgical analgesia. EXPAREL dosage is based on the following factors:
* size of surgical site
* volume required to cover the area
* individual patient factors that may impact the safety of an amide local anesthetic
* maximum doe of 266 mg (20 mL)
EXPAREL 1.3 % in 20 ML Injection: EXPAREL single shot dose given as an analgesia for arthroscopic rotator cuff repair surgery.
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|---|---|
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Age, Customized
Age
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56.6 years
STANDARD_DEVIATION 6.4 • n=13 Participants
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Sex: Female, Male
Female
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1 Participants
n=13 Participants
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Sex: Female, Male
Male
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12 Participants
n=13 Participants
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|
Region of Enrollment
United States
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13 participants
n=13 Participants
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PRIMARY outcome
Timeframe: 12 hours, 24 hours, 36 hours, 48 hoursPatient reported numeric pain rating using visual analog scale (VAS) (0 = none, 10 = severe)
Outcome measures
| Measure |
EXPAREL 1.3 % in 20 ML Injection
n=13 Participants
EXPAREL (bupivacaine liposome injectable suspension, 20 mL single use vial, 1.3% \[13.3 mg/mL\]) is a liposome injection of bupivacaine, an amide local anesthetic, indicated for single-dose infiltration into the surgical site to produce postsurgical analgesia. EXPAREL dosage is based on the following factors:
* size of surgical site
* volume required to cover the area
* individual patient factors that may impact the safety of an amide local anesthetic
* maximum doe of 266 mg (20 mL)
EXPAREL 1.3 % in 20 ML Injection: EXPAREL single shot dose given as an analgesia for arthroscopic rotator cuff repair surgery.
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|---|---|
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VAS Pain Score
12 Hours
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2.7 units on a scale
Standard Deviation 3.0
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VAS Pain Score
24 Hours
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3.2 units on a scale
Standard Deviation 3.5
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|
VAS Pain Score
36 Hours
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2.3 units on a scale
Standard Deviation 2.7
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|
VAS Pain Score
48 Hours
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2.1 units on a scale
Standard Deviation 2.6
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PRIMARY outcome
Timeframe: 12 hours, 24 hours, 36 hours, 48 hours, 3 days, 7 days, 14 daysNumber of narcotic medication tablets consumed
Outcome measures
| Measure |
EXPAREL 1.3 % in 20 ML Injection
n=13 Participants
EXPAREL (bupivacaine liposome injectable suspension, 20 mL single use vial, 1.3% \[13.3 mg/mL\]) is a liposome injection of bupivacaine, an amide local anesthetic, indicated for single-dose infiltration into the surgical site to produce postsurgical analgesia. EXPAREL dosage is based on the following factors:
* size of surgical site
* volume required to cover the area
* individual patient factors that may impact the safety of an amide local anesthetic
* maximum doe of 266 mg (20 mL)
EXPAREL 1.3 % in 20 ML Injection: EXPAREL single shot dose given as an analgesia for arthroscopic rotator cuff repair surgery.
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|---|---|
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Narcotic Medication Usage
12 Hours
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1.38 quantity of tablets
Standard Deviation 1.67
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Narcotic Medication Usage
24 Hours
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1.54 quantity of tablets
Standard Deviation 2.06
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Narcotic Medication Usage
36 Hours
|
1.68 quantity of tablets
Standard Deviation 2.08
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Narcotic Medication Usage
48 Hours
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1.36 quantity of tablets
Standard Deviation 1.44
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Narcotic Medication Usage
Day 3
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8.18 quantity of tablets
Standard Deviation 9.75
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Narcotic Medication Usage
Day 7
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14.42 quantity of tablets
Standard Deviation 16.45
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Narcotic Medication Usage
Day 14
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18.02 quantity of tablets
Standard Deviation 20.07
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SECONDARY outcome
Timeframe: 2 weeksAmerican Shoulder and Elbow Surgeons Shoulder Score (ASES) of surgical arm measured utilizing patient reported outcome surveys. (0 = no function; 100 = full function)
Outcome measures
| Measure |
EXPAREL 1.3 % in 20 ML Injection
n=13 Participants
EXPAREL (bupivacaine liposome injectable suspension, 20 mL single use vial, 1.3% \[13.3 mg/mL\]) is a liposome injection of bupivacaine, an amide local anesthetic, indicated for single-dose infiltration into the surgical site to produce postsurgical analgesia. EXPAREL dosage is based on the following factors:
* size of surgical site
* volume required to cover the area
* individual patient factors that may impact the safety of an amide local anesthetic
* maximum doe of 266 mg (20 mL)
EXPAREL 1.3 % in 20 ML Injection: EXPAREL single shot dose given as an analgesia for arthroscopic rotator cuff repair surgery.
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|---|---|
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American Shoulder and Elbow Surgeons Shoulder Score (ASES) on Surgical Arm
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48.8 score on a scale
Standard Deviation 7
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SECONDARY outcome
Timeframe: 2 weeksAmerican Shoulder and Elbow Surgeons Shoulder Score (ASES) of healthy (nonsurgical) arm measured utilizing patient reported outcome surveys. (0 = no function; 100 = full function)
Outcome measures
| Measure |
EXPAREL 1.3 % in 20 ML Injection
n=13 Participants
EXPAREL (bupivacaine liposome injectable suspension, 20 mL single use vial, 1.3% \[13.3 mg/mL\]) is a liposome injection of bupivacaine, an amide local anesthetic, indicated for single-dose infiltration into the surgical site to produce postsurgical analgesia. EXPAREL dosage is based on the following factors:
* size of surgical site
* volume required to cover the area
* individual patient factors that may impact the safety of an amide local anesthetic
* maximum doe of 266 mg (20 mL)
EXPAREL 1.3 % in 20 ML Injection: EXPAREL single shot dose given as an analgesia for arthroscopic rotator cuff repair surgery.
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|---|---|
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American Shoulder and Elbow Surgeons Shoulder Score (ASES) of Healthy Arm
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73.6 score on a scale
Standard Deviation 23.7
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Adverse Events
EXPAREL 1.3 % in 20 ML Injection
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place