Trial Outcomes & Findings for A Study of Loco-Regional Liposomal Bupivacaine Injection (NCT NCT05992896)
NCT ID: NCT05992896
Last Updated: 2026-05-29
Results Overview
The amount of narcotics used postoperatively 12 hours after injection, measured in morphine equivalent.
TERMINATED
PHASE4
3 participants
12 hours after injection
2026-05-29
Participant Flow
Participant milestones
| Measure |
Liposomal Bupivacaine Group
Subjects received an injection of liposomal bupivacaine during clinically indicated lower extremity revascularization surgery.
Bupivacaine liposome: Injection into pelvic area and into the edges of wound at the end of the procedure.
|
Placebo Group
Subjects received an injection of placebo during clinically indicated lower extremity revascularization surgery.
Placebo: Looks exactly like the study drug, but contains no active ingredients. Injection into pelvic area and into the edges of wound at the end of the procedure .
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
2
|
|
Overall Study
COMPLETED
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Liposomal Bupivacaine Group
Subjects received an injection of liposomal bupivacaine during clinically indicated lower extremity revascularization surgery.
Bupivacaine liposome: Injection into pelvic area and into the edges of wound at the end of the procedure.
|
Placebo Group
Subjects received an injection of placebo during clinically indicated lower extremity revascularization surgery.
Placebo: Looks exactly like the study drug, but contains no active ingredients. Injection into pelvic area and into the edges of wound at the end of the procedure .
|
|---|---|---|
|
Overall Study
Subject had normal surgery, did not receive injection due to pharmacy error.
|
0
|
1
|
Baseline Characteristics
A Study of Loco-Regional Liposomal Bupivacaine Injection
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: 12 hours after injectionPopulation: The study was terminated early. Only 2 participants completed the study (1 in each arm). Based on the low enrollment number, no data are reported here in order to protect and maintain participant privacy/confidentiality.
The amount of narcotics used postoperatively 12 hours after injection, measured in morphine equivalent.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 24 hours after injectionPopulation: The study was terminated early. Only 2 participants completed the study (1 in each arm). Based on the low enrollment number, no data are reported here in order to protect and maintain participant privacy/confidentiality.
The amount of narcotics used postoperatively 24 hours after injection, measured in morphine equivalent.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 48 hours after injectionPopulation: The study was terminated early. Only 2 participants completed the study (1 in each arm). Based on the low enrollment number, no data are reported here in order to protect and maintain participant privacy/confidentiality.
The amount of narcotics used postoperatively 48 hours after injection, measured in morphine equivalent.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 72 hours after injectionPopulation: The study was terminated early. Only 2 participants completed the study (1 in each arm). Based on the low enrollment number, no data are reported here in order to protect and maintain participant privacy/confidentiality.
The amount of narcotics used postoperatively 72 hours after injection, measured in morphine equivalent.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 30 days after injectionPopulation: The study was terminated early. Only 2 participants completed the study (1 in each arm). Based on the low enrollment number, no data are reported here in order to protect and maintain participant privacy/confidentiality.
The amount of narcotics used postoperatively 30 days after injection, measured in morphine equivalent.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 14 days after injectionPopulation: The study was terminated early. Only 2 participants completed the study (1 in each arm). Based on the low enrollment number, no data are reported here in order to protect and maintain participant privacy/confidentiality.
Measured using the self-reported quality of recovery score (QoR)-15. The 15-item questionnaire patient satisfaction survey over the last 24 hours on 11 point Likert scale for positive items, 0 = "none of the time" to 10 = "all of the time"; for negative items the scoring was reversed. Total score range 0 to 150, with higher scores indicating better quality of recovery.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 28 days after injectionPopulation: The study was terminated early. Only 2 participants completed the study (1 in each arm). Based on the low enrollment number, no data are reported here in order to protect and maintain participant privacy/confidentiality.
Measured using the self-reported quality of recovery score (QoR)-15. The 15-item questionnaire patient satisfaction survey over the last 24 hours on 11 point Likert scale for positive items, 0 = "none of the time" to 10 = "all of the time"; for negative items the scoring was reversed. Total score range 0 to 150, with higher scores indicating better quality of recovery.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: During surgery approximately 2 to 6 hoursPopulation: The study was terminated early. Only 2 participants completed the study (1 in each arm). Based on the low enrollment number, no data are reported here in order to protect and maintain participant privacy/confidentiality.
The amount of narcotics used during surgery, measured in morphine equivalent.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 28 daysPopulation: The study was terminated early. Only 2 participants completed the study (1 in each arm). Based on the low enrollment number, no data are reported here in order to protect and maintain participant privacy/confidentiality.
The total number of hours subjects were admitted to the hospital.
Outcome measures
Outcome data not reported
Adverse Events
Liposomal Bupivacaine Group
Placebo Group
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