Trial Outcomes & Findings for Randomized Controlled Trial for Exparel Hip Fracture (NCT NCT03289858)

Results Overview

Morphine meq given

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

55 participants

Primary outcome timeframe

72 hours

Results posted on

2021-03-18

Participant milestones
Measure	Exparel (Liposomal Bupivacaine) Exparel (liposomal bupivacaine) is FDA approved, with a labeled indication of "single-dose infiltration into the surgical site to produce postsurgical analgesia." Exparel: Subcutaneous injection at conclusion of surgical fixation of hip fracture	Saline Control Saline Solution (Sodium Chloride) Sodium Chloride: Saline Injection
Overall Study STARTED	27	28
Overall Study COMPLETED	25	28
Overall Study NOT COMPLETED	2	0

Withdrawal data not reported

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort
Measure	Exparel (Liposomal Bupivacaine) n=27 Participants Exparel (liposomal bupivacaine) is FDA approved, with a labeled indication of "single-dose infiltration into the surgical site to produce postsurgical analgesia." Exparel: Subcutaneous injection at conclusion of surgical fixation of hip fracture	Saline Control n=28 Participants Saline Solution (Sodium Chloride) Sodium Chloride: Saline Injection	Total n=55 Participants Total of all reporting groups
Age, Continuous	76 years STANDARD_DEVIATION 8.6 • n=27 Participants	77 years STANDARD_DEVIATION 9.2 • n=28 Participants	76 years STANDARD_DEVIATION 8.8 • n=55 Participants
Sex: Female, Male Female	20 Participants n=27 Participants	20 Participants n=28 Participants	40 Participants n=55 Participants
Sex: Female, Male Male	7 Participants n=27 Participants	8 Participants n=28 Participants	15 Participants n=55 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	27 participants n=27 Participants	28 participants n=28 Participants	55 participants n=55 Participants

Timeframe: 72 hours

Morphine meq given

Outcome measures
Measure	Exparel (Liposomal Bupivacaine) n=25 Participants Exparel (liposomal bupivacaine) is FDA approved, with a labeled indication of "single-dose infiltration into the surgical site to produce postsurgical analgesia." Exparel: Subcutaneous injection at conclusion of surgical fixation of hip fracture	Saline Control n=28 Participants Saline Solution (Sodium Chloride) Sodium Chloride: Saline Injection
Opiate Requirements	52.5 Morphine mEq Interval 30.21 to 74.75	65.39 Morphine mEq Interval 45.68 to 85.1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events
Measure	Exparel (Liposomal Bupivacaine) n=27 participants at risk Exparel (liposomal bupivacaine) is FDA approved, with a labeled indication of "single-dose infiltration into the surgical site to produce postsurgical analgesia." Exparel: Subcutaneous injection at conclusion of surgical fixation of hip fracture	Saline Control n=28 participants at risk Saline Solution (Sodium Chloride) Sodium Chloride: Saline Injection
Skin and subcutaneous tissue disorders Infection	0.00% 0/27 • 3 months Patients were actively screened for a list of complications daily during their admission and at their 2 and 6 week follow up appointments.	3.6% 1/28 • 3 months Patients were actively screened for a list of complications daily during their admission and at their 2 and 6 week follow up appointments.

Adverse event data not reported

University of Massachusetts, Worcester

Phone: 503-880-7125