Trial Outcomes & Findings for Single Shot Liposomal Bupivicaine in Rotator Cuff Surgery (NCT NCT03822182)
NCT ID: NCT03822182
Last Updated: 2020-11-12
Results Overview
Patient-reported post-operative VAS pain (on a scale of 0-10 with zero implying no pain and 10 indicating severe pain), measured post operatively, in 8-hour increments, for a total of 96 hours post-surgery, Patients will be prompted via text message to provide VAS pain every 8 hours. If a response text message is not received, a phone call will be made to obtain the information. Patients who do not have a smart phone will receive a phone call or keep a personal log of VAS pain.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
78 participants
Primary outcome timeframe
4 days post procedure
Results posted on
2020-11-12
Participant Flow
Enrollment was between November 2018 and January 2020 and inclusive of all patients with a torn rotator cuff in the clinical practice of the PI
A total of 78 patients were enrolled. 1 patient was excluded after inspect report showing current narcotic use. 1 patient was excluded for failure to submit data postoperatively.
Participant milestones
| Measure |
Control/Bupivicaine+DMSO
Group 1 will serve as the control and receive the standard injection consisting 30 ml of 0.5% bupivacaine and 0.4ml (4 mg) of dexamethasone.
Dexamethasone: steroid that will be used in control as well as in group 3 to see if effect with liposomal bupivicaine is prolonged as has been shown with standard bupivicaine.
|
Liposomal Bupivicaine
Group 2 will receive a block with 15ml 0.5% bupivacaine and 10ml (133mg) of liposomal bupivicaine (Exparel) and 5.4ml of Normal Saline
liposomal bupivicaine: The medication administered in the interscalene block is the intervention in this study.
|
Liposomal Bupivicaine + DMSO
Group 3 will receive 15ml of 0.5% bupivicaine and 10ml (133mg) of Liposomal Bupivicaine (Exparel) and 0.4ml (4mg) dexamethasone and 5ml normal saline
liposomal bupivicaine: The medication administered in the interscalene block is the intervention in this study.
|
|---|---|---|---|
|
Overall Study
STARTED
|
26
|
25
|
27
|
|
Overall Study
COMPLETED
|
26
|
24
|
26
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
Control/Bupivicaine+DMSO
Group 1 will serve as the control and receive the standard injection consisting 30 ml of 0.5% bupivacaine and 0.4ml (4 mg) of dexamethasone.
Dexamethasone: steroid that will be used in control as well as in group 3 to see if effect with liposomal bupivicaine is prolonged as has been shown with standard bupivicaine.
|
Liposomal Bupivicaine
Group 2 will receive a block with 15ml 0.5% bupivacaine and 10ml (133mg) of liposomal bupivicaine (Exparel) and 5.4ml of Normal Saline
liposomal bupivicaine: The medication administered in the interscalene block is the intervention in this study.
|
Liposomal Bupivicaine + DMSO
Group 3 will receive 15ml of 0.5% bupivicaine and 10ml (133mg) of Liposomal Bupivicaine (Exparel) and 0.4ml (4mg) dexamethasone and 5ml normal saline
liposomal bupivicaine: The medication administered in the interscalene block is the intervention in this study.
|
|---|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
1
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Group 1 Control
n=26 Participants
Group 1 will serve as the control and receive the standard injection consisting 30 ml of 0.5% bupivacaine and 0.4ml (4 mg) of dexamethasone.
Dexamethasone: steroid that will be used in control as well as in group 3 to see if effect with liposomal bupivicaine is prolonged as has been shown with standard bupivicaine.
|
Group 2
n=24 Participants
Group 2 will receive a block with 15ml 0.5% bupivacaine and 10ml (133mg) of liposomal bupivicaine (Exparel) and 5.4ml of Normal Saline
liposomal bupivicaine: The medication administered in the interscalene block is the intervention in this study. There are three different types of interscalene blocks that will be administered in order to compare the independent effectiveness of LB with the effectiveness of LB plus dexamethasone. Study participants will be randomized into one of three groups. The treatment groups are listed below:
|
Group 3
n=26 Participants
Group 3 will receive 15ml of 0.5% bupivicaine and 10ml (133mg) of Liposomal Bupivicaine (Exparel) and 0.4ml (4mg) dexamethasone and 5ml normal saline
liposomal bupivicaine: The medication administered in the interscalene block is the intervention in this study. There are three different types of interscalene blocks that will be administered in order to compare the independent effectiveness of LB with the effectiveness of LB plus dexamethasone. Study participants will be randomized into one of three groups. The treatment groups are listed below:
Dexamethasone: steroid that will be used in control as well as in group 3 to see if effect with liposomal bupivicaine is prolonged as has been shown with standard bupivicaine.
|
Total
n=76 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=26 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=76 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=26 Participants
|
19 Participants
n=24 Participants
|
22 Participants
n=26 Participants
|
62 Participants
n=76 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=26 Participants
|
5 Participants
n=24 Participants
|
4 Participants
n=26 Participants
|
14 Participants
n=76 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=26 Participants
|
10 Participants
n=24 Participants
|
14 Participants
n=26 Participants
|
35 Participants
n=76 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=26 Participants
|
14 Participants
n=24 Participants
|
12 Participants
n=26 Participants
|
41 Participants
n=76 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
26 participants
n=26 Participants
|
24 participants
n=24 Participants
|
26 participants
n=26 Participants
|
76 participants
n=76 Participants
|
PRIMARY outcome
Timeframe: 4 days post procedurePatient-reported post-operative VAS pain (on a scale of 0-10 with zero implying no pain and 10 indicating severe pain), measured post operatively, in 8-hour increments, for a total of 96 hours post-surgery, Patients will be prompted via text message to provide VAS pain every 8 hours. If a response text message is not received, a phone call will be made to obtain the information. Patients who do not have a smart phone will receive a phone call or keep a personal log of VAS pain.
Outcome measures
| Measure |
Control/Bupivicaine+DMSO
n=26 Participants
Group 1 will serve as the control and receive the standard injection consisting 30 ml of 0.5% bupivacaine and 0.4ml (4 mg) of dexamethasone.
Dexamethasone: steroid that will be used in control as well as in group 3 to see if effect with liposomal bupivicaine is prolonged as has been shown with standard bupivicaine.
|
Liposomal Bupivicaine
n=24 Participants
Group 2 will receive a block with 15ml 0.5% bupivacaine and 10ml (133mg) of liposomal bupivicaine (Exparel) and 5.4ml of Normal Saline
liposomal bupivicaine: The medication administered in the interscalene block is the intervention in this study. There are three different types of interscalene blocks that will be administered in order to compare the independent effectiveness of LB with the effectiveness of LB plus dexamethasone. Study participants will be randomized into one of three groups. The treatment groups are listed below:
Group 1 (Control): 30 ml of 0.5% bupivacaine and 0.4ml (4 mg) of dexamethasone Group 2: 15ml 0.5% bupivacaine and 10ml (133mg) of LB (Exparel) and 5.4ml normal saline Group 3: 5ml 0.5% bupivacaine and 10ml LB (Exparel) and 0.4ml (4 mg) dexamethasone and 5ml normal saline
|
Liposomal Bupivicaine + DMSO
n=26 Participants
Group 3 will receive 15ml of 0.5% bupivicaine and 10ml (133mg) of Liposomal Bupivicaine (Exparel) and 0.4ml (4mg) dexamethasone and 5ml normal saline
liposomal bupivicaine: The medication administered in the interscalene block is the intervention in this study. There are three different types of interscalene blocks that will be administered in order to compare the independent effectiveness of LB with the effectiveness of LB plus dexamethasone. Study participants will be randomized into one of three groups. The treatment groups are listed below:
Group 1 (Control): 30 ml of 0.5% bupivacaine and 0.4ml (4 mg) of dexamethasone Group 2: 15ml 0.5% bupivacaine and 10ml (133mg) of LB (Exparel) and 5.4ml normal saline Group 3: 5ml 0.5% bupivacaine and 10ml LB (Exparel) and 0.4ml (4 mg) dexamethasone and 5ml normal saline
Dexamethasone: steroid that will be used in control as well as in group 3 to see if effect with liposomal bupivicaine is prolonged as has been shown with standard
|
|---|---|---|---|
|
Patient Reported Postoperative Pain: VAS
Postoperative day 1 VAS
|
3.1 units on a scale
Standard Deviation 1.9
|
3.5 units on a scale
Standard Deviation 2.2
|
2.4 units on a scale
Standard Deviation 1.8
|
|
Patient Reported Postoperative Pain: VAS
Postoperative day 2 VAS
|
3.3 units on a scale
Standard Deviation 1.8
|
2.8 units on a scale
Standard Deviation 2.0
|
2.8 units on a scale
Standard Deviation 1.7
|
|
Patient Reported Postoperative Pain: VAS
Postoperative day 3 VAS
|
2.4 units on a scale
Standard Deviation 1.6
|
3.2 units on a scale
Standard Deviation 2.1
|
2.1 units on a scale
Standard Deviation 1.3
|
|
Patient Reported Postoperative Pain: VAS
Postoperative day 4 VAS
|
1.9 units on a scale
Standard Deviation 1.3
|
2.9 units on a scale
Standard Deviation 1.9
|
2.3 units on a scale
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: 4 days post procedurePatient-reported post-operative opioid use (converted to morphine equivalents), collected post operatively, in 8-hour increments, for a total of 96 hours post-surgery Patients will be prompted via text message to provide the amount of narcotics (number of pills converted to morphine equivalents) taken over the course of the previous 8 hours. If a response text message is not received, a phone call will be made to obtain the information. Patients who do not have a smart phone will receive a phone call or keep a personal log of narcotic use.
Outcome measures
| Measure |
Control/Bupivicaine+DMSO
n=26 Participants
Group 1 will serve as the control and receive the standard injection consisting 30 ml of 0.5% bupivacaine and 0.4ml (4 mg) of dexamethasone.
Dexamethasone: steroid that will be used in control as well as in group 3 to see if effect with liposomal bupivicaine is prolonged as has been shown with standard bupivicaine.
|
Liposomal Bupivicaine
n=24 Participants
Group 2 will receive a block with 15ml 0.5% bupivacaine and 10ml (133mg) of liposomal bupivicaine (Exparel) and 5.4ml of Normal Saline
liposomal bupivicaine: The medication administered in the interscalene block is the intervention in this study. There are three different types of interscalene blocks that will be administered in order to compare the independent effectiveness of LB with the effectiveness of LB plus dexamethasone. Study participants will be randomized into one of three groups. The treatment groups are listed below:
Group 1 (Control): 30 ml of 0.5% bupivacaine and 0.4ml (4 mg) of dexamethasone Group 2: 15ml 0.5% bupivacaine and 10ml (133mg) of LB (Exparel) and 5.4ml normal saline Group 3: 5ml 0.5% bupivacaine and 10ml LB (Exparel) and 0.4ml (4 mg) dexamethasone and 5ml normal saline
|
Liposomal Bupivicaine + DMSO
n=26 Participants
Group 3 will receive 15ml of 0.5% bupivicaine and 10ml (133mg) of Liposomal Bupivicaine (Exparel) and 0.4ml (4mg) dexamethasone and 5ml normal saline
liposomal bupivicaine: The medication administered in the interscalene block is the intervention in this study. There are three different types of interscalene blocks that will be administered in order to compare the independent effectiveness of LB with the effectiveness of LB plus dexamethasone. Study participants will be randomized into one of three groups. The treatment groups are listed below:
Group 1 (Control): 30 ml of 0.5% bupivacaine and 0.4ml (4 mg) of dexamethasone Group 2: 15ml 0.5% bupivacaine and 10ml (133mg) of LB (Exparel) and 5.4ml normal saline Group 3: 5ml 0.5% bupivacaine and 10ml LB (Exparel) and 0.4ml (4 mg) dexamethasone and 5ml normal saline
Dexamethasone: steroid that will be used in control as well as in group 3 to see if effect with liposomal bupivicaine is prolonged as has been shown with standard
|
|---|---|---|---|
|
Patient Reported Post Operative Opioid Use
POD 1 MME
|
26.5 morphine milligram equivalents
Standard Deviation 22.0
|
22.8 morphine milligram equivalents
Standard Deviation 22.3
|
18.8 morphine milligram equivalents
Standard Deviation 12.8
|
|
Patient Reported Post Operative Opioid Use
POD 2 MME
|
36.1 morphine milligram equivalents
Standard Deviation 22.9
|
21.9 morphine milligram equivalents
Standard Deviation 24.9
|
22.8 morphine milligram equivalents
Standard Deviation 17.7
|
|
Patient Reported Post Operative Opioid Use
POD 3 MME
|
29.7 morphine milligram equivalents
Standard Deviation 24.9
|
17.8 morphine milligram equivalents
Standard Deviation 21.8
|
14.4 morphine milligram equivalents
Standard Deviation 14.7
|
|
Patient Reported Post Operative Opioid Use
POD 4 MME
|
21.1 morphine milligram equivalents
Standard Deviation 17.9
|
18.1 morphine milligram equivalents
Standard Deviation 23.9
|
16.8 morphine milligram equivalents
Standard Deviation 16.2
|
Adverse Events
Control/Bupivicaine +DMSO
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Liposomal Bupivicaine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Liposomal Bupivicaine + DMS)
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