Trial Outcomes & Findings for Liposomal Bupivacaine vs Peripheral Nerve Block (NCT NCT03922620)

Results Overview

Best 0-10 worst - Continuous scale to measure current pain level

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

1 participants

Primary outcome timeframe

Baseline and 6 weeks

Results posted on

2023-02-23

Participant Flow

Participant milestones

Participant milestones
Measure	Liposomal Bupivacaine Group No peripheral nerve block will be given. Local infiltration of 20cc of Liposomal Bupivacaine infiltrated to the surgical area. Liposomal bupivacaine: Local infiltration of 20cc of Liposomal Bupivacaine infiltrated to the surgical area	Peripheral Nerve Block Group Peripheral Nerve Block performed by anesthesia team (blocks will be given by same anesthesia provider utilizing same technique every time in order to reduce variations in delivery of peripheral nerve block). No local analgesic agent infiltration Peripheral Nerve Block: Peripheral Nerve Block performed by anesthesia team (blocks will be given by same anesthesia provider utilizing same technique every time in order to reduce variations in delivery of peripheral nerve block).
Overall Study STARTED	1	0
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Liposomal Bupivacaine Group No peripheral nerve block will be given. Local infiltration of 20cc of Liposomal Bupivacaine infiltrated to the surgical area. Liposomal bupivacaine: Local infiltration of 20cc of Liposomal Bupivacaine infiltrated to the surgical area	Peripheral Nerve Block Group Peripheral Nerve Block performed by anesthesia team (blocks will be given by same anesthesia provider utilizing same technique every time in order to reduce variations in delivery of peripheral nerve block). No local analgesic agent infiltration Peripheral Nerve Block: Peripheral Nerve Block performed by anesthesia team (blocks will be given by same anesthesia provider utilizing same technique every time in order to reduce variations in delivery of peripheral nerve block).
Overall Study Data and outcome measures not tabulated due to discontinued enrollment.	1	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Liposomal Bupivacaine Group n=1 Participants No peripheral nerve block will be given. Local infiltration of 20cc of Liposomal Bupivacaine infiltrated to the surgical area. Liposomal bupivacaine: Local infiltration of 20cc of Liposomal Bupivacaine infiltrated to the surgical area	Peripheral Nerve Block Group Peripheral Nerve Block performed by anesthesia team (blocks will be given by same anesthesia provider utilizing same technique every time in order to reduce variations in delivery of peripheral nerve block). No local analgesic agent infiltration Peripheral Nerve Block: Peripheral Nerve Block performed by anesthesia team (blocks will be given by same anesthesia provider utilizing same technique every time in order to reduce variations in delivery of peripheral nerve block).	Total n=1 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=1 Participants	—	0 Participants n=1 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=1 Participants	—	1 Participants n=1 Participants
Age, Categorical >=65 years	0 Participants n=1 Participants	—	0 Participants n=1 Participants
Age, Continuous	48 years STANDARD_DEVIATION 0 • n=1 Participants	—	48 years STANDARD_DEVIATION 0 • n=1 Participants
Sex: Female, Male Female	1 Participants n=1 Participants	0 Participants	1 Participants n=1 Participants
Sex: Female, Male Male	0 Participants n=1 Participants	0 Participants	0 Participants n=1 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	1 participants n=1 Participants	—	1 participants n=1 Participants

PRIMARY outcome

Timeframe: Baseline and 6 weeks

Population: One participant analyzed at baseline as only one total participant was enrolled. No data was displayed at 6 weeks time frame because data was not collected by investigator(s)."

Best 0-10 worst - Continuous scale to measure current pain level

Outcome measures

Outcome measures
Measure	Liposomal Bupivacaine Group n=1 Participants No peripheral nerve block will be given. Local infiltration of 20cc of Liposomal Bupivacaine infiltrated to the surgical area. Liposomal bupivacaine: Local infiltration of 20cc of Liposomal Bupivacaine infiltrated to the surgical area	Peripheral Nerve Block Group Peripheral Nerve Block performed by anesthesia team (blocks will be given by same anesthesia provider utilizing same technique every time in order to reduce variations in delivery of peripheral nerve block). No local analgesic agent infiltration Peripheral Nerve Block: Peripheral Nerve Block performed by anesthesia team (blocks will be given by same anesthesia provider utilizing same technique every time in order to reduce variations in delivery of peripheral nerve block).
Visual Analog Scale Pain Score Baseline	6 score on a scale	—

SECONDARY outcome

Timeframe: 0-6 weeks

Population: Data was not collected by investigator(s).

morphine equivalents consumed for post-operative pain control

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 0-6 weeks

Population: Data was not collected by investigator(s).

asks patients to rate their level of satisfaction with their pain control on a scale of 0-10, 0 being not satisfied at all and 10 being highly satisfied

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 0-6 weeks

Population: Data was not collected by investigator(s).

range of motion measured using goniometer

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 weeks

Population: One participant analyzed as only one total participant was enrolled.

complications after surgery including infection and delayed healing

Outcome measures

Outcome measures
Measure	Liposomal Bupivacaine Group n=1 Participants No peripheral nerve block will be given. Local infiltration of 20cc of Liposomal Bupivacaine infiltrated to the surgical area. Liposomal bupivacaine: Local infiltration of 20cc of Liposomal Bupivacaine infiltrated to the surgical area	Peripheral Nerve Block Group Peripheral Nerve Block performed by anesthesia team (blocks will be given by same anesthesia provider utilizing same technique every time in order to reduce variations in delivery of peripheral nerve block). No local analgesic agent infiltration Peripheral Nerve Block: Peripheral Nerve Block performed by anesthesia team (blocks will be given by same anesthesia provider utilizing same technique every time in order to reduce variations in delivery of peripheral nerve block).
Number of Participants With Complications	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 6 weeks

Population: One participant analyzed as only one total participant was enrolled.

unscheduled healthcare contact includes patient calls/messages, emergency room visits, or scheduled clinic visits

Outcome measures

Outcome measures
Measure	Liposomal Bupivacaine Group n=1 Participants No peripheral nerve block will be given. Local infiltration of 20cc of Liposomal Bupivacaine infiltrated to the surgical area. Liposomal bupivacaine: Local infiltration of 20cc of Liposomal Bupivacaine infiltrated to the surgical area	Peripheral Nerve Block Group Peripheral Nerve Block performed by anesthesia team (blocks will be given by same anesthesia provider utilizing same technique every time in order to reduce variations in delivery of peripheral nerve block). No local analgesic agent infiltration Peripheral Nerve Block: Peripheral Nerve Block performed by anesthesia team (blocks will be given by same anesthesia provider utilizing same technique every time in order to reduce variations in delivery of peripheral nerve block).
Number of Participants With Unscheduled Healthcare Contact	0 Participants	0 Participants

Adverse Events

Liposomal Bupivacaine Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Peripheral Nerve Block 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

Dr. Gerard Cush

Geisinger Medical Center

Phone: 5702716700

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place