Trial Outcomes & Findings for Liposomal Bupivacaine for Pain Control Following Anterior Cruciate Ligament Reconstruction (NCT NCT02189317)
NCT ID: NCT02189317
Last Updated: 2016-07-27
Results Overview
The numerical rating scale (NRS) pain score is a self-reported pain scale from 0 to 10 where zero is equal to "no pain" and ten is equal to "worst possible" pain. The score was recorded every 12 hours for up to 144 hours (six days) post-operatively.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
50 participants
Primary outcome timeframe
Day of Surgery, Post-Operative Day 6 (Up to 144 hours)
Results posted on
2016-07-27
Participant Flow
Participants were recruited from an ambulatory surgery center from July 2014 to March 2015.
Of the fifty participants who consented for the study, 18 participants who had different graph types were excluded to avoid a potential confounder. Thirty two participants were included in the overall study who had identical graph types.
Participant milestones
| Measure |
Bupivacaine HCl
Participants undergoing primary anterior cruciate ligament (ACL) reconstruction with a soft tissue quadriceps tendon autograft received a femoral block immediately before surgery. Participants then received 20 mL 0.25% bupivacaine HCl and 20 ml 0.9% injectable saline administered into the graft harvest site and portal sites during surgery.
|
Exparel (Bupivacaine Liposome)
Participants undergoing primary anterior cruciate ligament (ACL) reconstruction with a soft tissue quadriceps tendon autograft received a femoral block immediately before surgery. Participants then received a 40-mL suspension of 20 mL Exparel (1 vial of bupivacaine liposome injectable suspension) and 20 mL 0.9% injectable saline administered into the graft harvest site and portal sites during surgery.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
16
|
|
Overall Study
COMPLETED
|
16
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Liposomal Bupivacaine for Pain Control Following Anterior Cruciate Ligament Reconstruction
Baseline characteristics by cohort
| Measure |
Bupivacaine HCl
n=16 Participants
Participants undergoing primary anterior cruciate ligament (ACL) reconstruction with a soft tissue quadriceps tendon autograft received a femoral block immediately before surgery. Participants then received 20 mL 0.25% bupivacaine HCl and 20 ml 0.9% injectable saline administered into the graft harvest site and portal sites during surgery.
|
Exparel (Liposomal Bupivacaine)
n=16 Participants
Participants undergoing primary anterior cruciate ligament (ACL) reconstruction with a soft tissue quadriceps tendon autograft received a femoral block immediately before surgery. Participants then received a 40-mL suspension of 20 mL Exparel (1 vial of bupivacaine liposome injectable suspension) and 20 mL 0.9% injectable saline administered into the graft harvest site and portal sites during surgery.
|
Total
n=32 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
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
16 participants
n=7 Participants
|
32 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day of Surgery, Post-Operative Day 6 (Up to 144 hours)Population: Participants who underwent ACL reconstruction surgery and returned a completed post-operative pain and medication journal (bupivacaine HCl group). Participants who underwent ACL reconstruction surgery, returned a completed post-operative pain and medication journal, and did not require reoperation (Exparel liposomal/bupivacaine group).
The numerical rating scale (NRS) pain score is a self-reported pain scale from 0 to 10 where zero is equal to "no pain" and ten is equal to "worst possible" pain. The score was recorded every 12 hours for up to 144 hours (six days) post-operatively.
Outcome measures
| Measure |
Bupivacaine HCl
n=15 Participants
Participants undergoing primary anterior cruciate ligament (ACL) reconstruction with a soft tissue quadriceps tendon autograft received a femoral block immediately before surgery. Participants then received 20 mL 0.25% bupivacaine HCl and 20 ml 0.9% injectable saline administered into the graft harvest site and portal sites during surgery.
|
Exparel (Liposomal Bupivacaine)
n=14 Participants
Participants undergoing primary anterior cruciate ligament (ACL) reconstruction with a soft tissue quadriceps tendon autograft received a femoral block immediately before surgery. Participants then received a 40-mL suspension of 20 mL Exparel (1 vial of bupivacaine liposome injectable suspension) and 20 mL 0.9% injectable saline administered into the graft harvest site and portal sites during surgery.
|
|---|---|---|
|
Change in Numerical Rating Scale (NRS) Pain Score
Baseline (recovery room)
|
3.6 units on a scale
Standard Deviation 2.1
|
4.7 units on a scale
Standard Deviation 2.0
|
|
Change in Numerical Rating Scale (NRS) Pain Score
Evening on the day of surgery
|
5.0 units on a scale
Standard Deviation 3.7
|
4.1 units on a scale
Standard Deviation 2.3
|
|
Change in Numerical Rating Scale (NRS) Pain Score
Day 1 Morning
|
5.7 units on a scale
Standard Deviation 2.5
|
4.5 units on a scale
Standard Deviation 2.1
|
|
Change in Numerical Rating Scale (NRS) Pain Score
Day 1 Evening
|
5.2 units on a scale
Standard Deviation 2.6
|
5.6 units on a scale
Standard Deviation 1.7
|
|
Change in Numerical Rating Scale (NRS) Pain Score
Day 2 Morning
|
5.1 units on a scale
Standard Deviation 2.6
|
4.9 units on a scale
Standard Deviation 2.5
|
|
Change in Numerical Rating Scale (NRS) Pain Score
Day 2 Evening
|
4.1 units on a scale
Standard Deviation 2.4
|
4.7 units on a scale
Standard Deviation 1.9
|
|
Change in Numerical Rating Scale (NRS) Pain Score
Day 3 Morning
|
3.7 units on a scale
Standard Deviation 2.5
|
4.8 units on a scale
Standard Deviation 1.7
|
|
Change in Numerical Rating Scale (NRS) Pain Score
Day 3 Evening
|
3.6 units on a scale
Standard Deviation 2.5
|
4.5 units on a scale
Standard Deviation 2.0
|
|
Change in Numerical Rating Scale (NRS) Pain Score
Day 4 Morning
|
3.3 units on a scale
Standard Deviation 2.2
|
4.1 units on a scale
Standard Deviation 2.0
|
|
Change in Numerical Rating Scale (NRS) Pain Score
Day 4 Evening
|
3.0 units on a scale
Standard Deviation 2.0
|
3.6 units on a scale
Standard Deviation 2.1
|
|
Change in Numerical Rating Scale (NRS) Pain Score
Day 5 Morning
|
3.3 units on a scale
Standard Deviation 2.1
|
2.8 units on a scale
Standard Deviation 2.5
|
|
Change in Numerical Rating Scale (NRS) Pain Score
Day 5 Evening
|
3.1 units on a scale
Standard Deviation 2.1
|
2.5 units on a scale
Standard Deviation 2.4
|
|
Change in Numerical Rating Scale (NRS) Pain Score
Day 6 Morning
|
3.3 units on a scale
Standard Deviation 2.2
|
2.5 units on a scale
Standard Deviation 2.4
|
|
Change in Numerical Rating Scale (NRS) Pain Score
Day 6 Evening
|
2.4 units on a scale
Standard Deviation 2.3
|
1.4 units on a scale
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: Day of Surgery, Post-Operative Day 6 (Up to 144 hours)Population: Participants who underwent ACL reconstruction surgery and returned a completed post-operative pain and medication journal (bupivacaine HCl group). Participants who underwent ACL reconstruction surgery, returned a completed post-operative pain and medication journal, and did not require reoperation (Exparel liposomal/bupivacaine group).
The difference in amount of Percocet (7.5/325 tablets) usage post-surgery.
Outcome measures
| Measure |
Bupivacaine HCl
n=15 Participants
Participants undergoing primary anterior cruciate ligament (ACL) reconstruction with a soft tissue quadriceps tendon autograft received a femoral block immediately before surgery. Participants then received 20 mL 0.25% bupivacaine HCl and 20 ml 0.9% injectable saline administered into the graft harvest site and portal sites during surgery.
|
Exparel (Liposomal Bupivacaine)
n=14 Participants
Participants undergoing primary anterior cruciate ligament (ACL) reconstruction with a soft tissue quadriceps tendon autograft received a femoral block immediately before surgery. Participants then received a 40-mL suspension of 20 mL Exparel (1 vial of bupivacaine liposome injectable suspension) and 20 mL 0.9% injectable saline administered into the graft harvest site and portal sites during surgery.
|
|---|---|---|
|
Change in Home Opioid Use
Up to 72 hours
|
10.2 miligrams
Standard Deviation 4.8
|
9.3 miligrams
Standard Deviation 6.9
|
|
Change in Home Opioid Use
Day of Surgery
|
1.6 miligrams
Standard Deviation 1.3
|
2.5 miligrams
Standard Deviation 1.5
|
|
Change in Home Opioid Use
Postoperative Day 1
|
4.9 miligrams
Standard Deviation 2.9
|
4.1 miligrams
Standard Deviation 3.2
|
|
Change in Home Opioid Use
Postoperative Day 2
|
4.0 miligrams
Standard Deviation 2.1
|
2.3 miligrams
Standard Deviation 2.5
|
|
Change in Home Opioid Use
Postoperative Day 3
|
2.3 miligrams
Standard Deviation 1.9
|
1.3 miligrams
Standard Deviation 1.5
|
|
Change in Home Opioid Use
Postoperative Day 4
|
1.7 miligrams
Standard Deviation 1.4
|
0.8 miligrams
Standard Deviation 1.0
|
|
Change in Home Opioid Use
Postoperative Day 5
|
1.6 miligrams
Standard Deviation 1.5
|
0.2 miligrams
Standard Deviation 0.4
|
|
Change in Home Opioid Use
Postoperative Day 6
|
1.6 miligrams
Standard Deviation 1.6
|
0.3 miligrams
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: Day of Surgery, Post-Operative Day 6 (Up to 144 hours)Population: Participants who underwent ACL reconstruction surgery and returned a completed post-operative pain and medication journal (bupivacaine HCl group). Participants who underwent ACL reconstruction surgery, returned a completed post-operative pain and medication journal, and did not require reoperation (Exparel liposomal/bupivacaine group).
The time difference in hours to first Percocet (7.5/325 tablets) usage post-surgery.
Outcome measures
| Measure |
Bupivacaine HCl
n=15 Participants
Participants undergoing primary anterior cruciate ligament (ACL) reconstruction with a soft tissue quadriceps tendon autograft received a femoral block immediately before surgery. Participants then received 20 mL 0.25% bupivacaine HCl and 20 ml 0.9% injectable saline administered into the graft harvest site and portal sites during surgery.
|
Exparel (Liposomal Bupivacaine)
n=14 Participants
Participants undergoing primary anterior cruciate ligament (ACL) reconstruction with a soft tissue quadriceps tendon autograft received a femoral block immediately before surgery. Participants then received a 40-mL suspension of 20 mL Exparel (1 vial of bupivacaine liposome injectable suspension) and 20 mL 0.9% injectable saline administered into the graft harvest site and portal sites during surgery.
|
|---|---|---|
|
Difference in Time to First Opioid Use
|
3.2 hours
Standard Deviation 2.1
|
3.1 hours
Standard Deviation 0.7
|
Adverse Events
Bupivacaine HCl
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Exparel (Bupivacaine Liposome)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Bupivacaine HCl
n=16 participants at risk
Participants undergoing primary anterior cruciate ligament (ACL) reconstruction with a soft tissue quadriceps tendon autograft received a femoral block immediately before surgery. Participants then received 20 mL 0.25% bupivacaine HCl and 20 ml 0.9% injectable saline administered into the graft harvest site and portal sites during surgery.
|
Exparel (Bupivacaine Liposome)
n=16 participants at risk
Participants undergoing primary anterior cruciate ligament (ACL) reconstruction with a soft tissue quadriceps tendon autograft received a femoral block immediately before surgery. Participants then received a 40-mL suspension of 20 mL Exparel (1 vial of bupivacaine liposome injectable suspension) and 20 mL 0.9% injectable saline administered into the graft harvest site and portal sites during surgery.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Post-operative Hematoma
|
0.00%
0/16
|
6.2%
1/16 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place