Trial Outcomes & Findings for Postsurgical Bupivacaine Extended-release Liposome Injection for Open-reduction Internal Distal Radius Fixation. (NCT NCT02515851)

Results Overview

the amount of pain medication used in the three days following surgery.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

30 participants

Primary outcome timeframe

three days

Results posted on

2017-11-20

Participant Flow

Participant milestones

Participant milestones
Measure	Active Group Group that receives actual liposomal bupivacaine injections Exparel	Placebo Group Group that receives placebo injections Placebo
Overall Study STARTED	15	15
Overall Study COMPLETED	15	15
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Postsurgical Bupivacaine Extended-release Liposome Injection for Open-reduction Internal Distal Radius Fixation.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active Group n=15 Participants Group that receives actual liposomal bupivacaine injections Exparel	Placebo Group n=15 Participants Group that receives placebo injections Placebo	Total n=30 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	15 Participants n=5 Participants	15 Participants n=7 Participants	30 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	5 Participants n=5 Participants	8 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	7 Participants n=7 Participants	17 Participants n=5 Participants

PRIMARY outcome

Timeframe: three days

Population: Data were not collected

the amount of pain medication used in the three days following surgery.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 7 days after surgery

Population: Data were not collected

The total narcotic pain medication usage for 1 week after surgery

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 7 days after surgery

Population: Data were not collected

Wrist range of motion possible when surgeon moves the wrist between 0 and 180 degrees.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 7 days after surgery

Population: Data were not collected

Patients will rate satisfaction with their surgery and recovery on a 1 to 10 scale with 1 being the lest and 10 being the most satisfied.

Outcome measures

Outcome data not reported

Adverse Events

Active Group

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

Nancy Alsip

University Louisville

Phone: 502-852-2610

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place