Trial Outcomes & Findings for A Randomized Trial of Exparel vs Saline in Opioid Reduction of Pain Management Following Lumbar Spine Surgeries. (NCT NCT04644796)
NCT ID: NCT04644796
Last Updated: 2023-06-13
Results Overview
Comparing post operative opioid usage reduction between treatment and placebo group.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
34 participants
Primary outcome timeframe
Until final follow-up, up to 8 weeks.
Results posted on
2023-06-13
Participant Flow
Participant milestones
| Measure |
Liposomal Bupivacaine
Patients in this group will be given the study drug (liposomal bupivacaine).
Liposomal bupivacaine: Patients included in the treatment group will have their incisional site infused, targeting the paraspinal muscles with liposomal bupivacaine at the end of their surgery.
|
Placebo Group
Patients in this group will be given the placebo (sterile saline).
saline 0.9%: Patients included in the placebo group will have their incisional site infused, targeting the paraspinal muscles with sterile saline at the end of their surgery.
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
17
|
|
Overall Study
COMPLETED
|
17
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Liposomal Bupivacaine
n=17 Participants
Patients in this group will be given the study drug (liposomal bupivacaine).
Liposomal bupivacaine: Patients included in the treatment group will have their incisional site infused, targeting the paraspinal muscles with liposomal bupivacaine at the end of their surgery.
|
Placebo Group
n=17 Participants
Patients in this group will be given the placebo (sterile saline).
saline 0.9%: Patients included in the placebo group will have their incisional site infused, targeting the paraspinal muscles with sterile saline at the end of their surgery.
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=17 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=34 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=17 Participants
|
8 Participants
n=17 Participants
|
16 Participants
n=34 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=17 Participants
|
9 Participants
n=17 Participants
|
18 Participants
n=34 Participants
|
|
Age, Continuous
|
63 years
n=17 Participants
|
65 years
n=17 Participants
|
64 years
n=34 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=17 Participants
|
12 Participants
n=17 Participants
|
24 Participants
n=34 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=17 Participants
|
5 Participants
n=17 Participants
|
10 Participants
n=34 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
17 participants
n=17 Participants
|
17 participants
n=17 Participants
|
34 participants
n=34 Participants
|
PRIMARY outcome
Timeframe: Until final follow-up, up to 8 weeks.Population: Discrepancy comes from patients not reporting morphine milligram equivalents on survey.
Comparing post operative opioid usage reduction between treatment and placebo group.
Outcome measures
| Measure |
Placebo Group
n=14 Participants
Patients in this group will be given the placebo (sterile saline).
saline 0.9%: Patients included in the placebo group will have their incisional site infused, targeting the paraspinal muscles with sterile saline at the end of their surgery.
|
Liposomal Bupivacaine
n=15 Participants
Patients in this group will be given the study drug (liposomal bupivacaine).
Liposomal bupivacaine: Patients included in the treatment group will have their incisional site infused, targeting the paraspinal muscles with liposomal bupivacaine at the end of their surgery.
|
|---|---|---|
|
Postoperative Opioid Utilization
|
4.82 morphine milligram equivalents
Standard Deviation 10.02
|
9.17 morphine milligram equivalents
Standard Deviation 19.36
|
SECONDARY outcome
Timeframe: Until final follow-up or up to 8 weeks after surgery date, whichever comes first.Population: Reason for participant discrepancy is patients did not fill our VAS pain score survey following surgery.
Comparing post operative pain scores between treatment and placebo group. Using Visual Analogue Scale (VAS) pain score with scale 0 to 10 with 0 being no pain and 10 being the worst pain of your life.
Outcome measures
| Measure |
Placebo Group
n=15 Participants
Patients in this group will be given the placebo (sterile saline).
saline 0.9%: Patients included in the placebo group will have their incisional site infused, targeting the paraspinal muscles with sterile saline at the end of their surgery.
|
Liposomal Bupivacaine
n=16 Participants
Patients in this group will be given the study drug (liposomal bupivacaine).
Liposomal bupivacaine: Patients included in the treatment group will have their incisional site infused, targeting the paraspinal muscles with liposomal bupivacaine at the end of their surgery.
|
|---|---|---|
|
Post Operative Pain Scores
|
4.80 score on a scale
Standard Deviation 1.92
|
4.05 score on a scale
Standard Deviation 1.74
|
SECONDARY outcome
Timeframe: Until final follow-up, up to 8 weeks.Determining how long patient is in hospital.
Outcome measures
| Measure |
Placebo Group
n=17 Participants
Patients in this group will be given the placebo (sterile saline).
saline 0.9%: Patients included in the placebo group will have their incisional site infused, targeting the paraspinal muscles with sterile saline at the end of their surgery.
|
Liposomal Bupivacaine
n=17 Participants
Patients in this group will be given the study drug (liposomal bupivacaine).
Liposomal bupivacaine: Patients included in the treatment group will have their incisional site infused, targeting the paraspinal muscles with liposomal bupivacaine at the end of their surgery.
|
|---|---|---|
|
Length of Stay
|
42.69 Hours
Standard Deviation 40.62
|
29.51 Hours
Standard Deviation 19.32
|
SECONDARY outcome
Timeframe: Until final follow-up, up to 8 weeks.Comparing intraoperative complications, acute postoperative complication, and opioid complications.
Outcome measures
| Measure |
Placebo Group
n=17 Participants
Patients in this group will be given the placebo (sterile saline).
saline 0.9%: Patients included in the placebo group will have their incisional site infused, targeting the paraspinal muscles with sterile saline at the end of their surgery.
|
Liposomal Bupivacaine
n=17 Participants
Patients in this group will be given the study drug (liposomal bupivacaine).
Liposomal bupivacaine: Patients included in the treatment group will have their incisional site infused, targeting the paraspinal muscles with liposomal bupivacaine at the end of their surgery.
|
|---|---|---|
|
Operative Data and Complications
Intraoperative Complications · None
|
17 Participants
|
17 Participants
|
|
Operative Data and Complications
Intraoperative Complications · Yes
|
0 Participants
|
0 Participants
|
|
Operative Data and Complications
Acute Postoperative Complication · None
|
15 Participants
|
16 Participants
|
|
Operative Data and Complications
Acute Postoperative Complication · Yes
|
2 Participants
|
1 Participants
|
|
Operative Data and Complications
Opioid Complications · None
|
17 Participants
|
17 Participants
|
|
Operative Data and Complications
Opioid Complications · Yes
|
0 Participants
|
0 Participants
|
Adverse Events
Liposomal Bupivacaine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Group
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