Trial Outcomes & Findings for Hip Fracture Exparel Administration Trial Capsule During Hemiarthroplasty (NCT NCT03502018)

NCT ID: NCT03502018

Last Updated: 2023-11-18

Results Overview

Primary outcome measure will be postoperative visual analogue scale (VAS from 0-10) pain scores. 0 = no pain, 10 = most pain

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 50 participants
• Primary outcome timeframe: 4hrs after surgery
• Results posted on: 2023-11-18

Participant Flow

Participant milestones

Measure	Saline This arm will receive Saline along with Bupivacaine Saline: Saline injection used as control	Bupivacaine Liposome This arm will receive Exparel along with Bupivacaine Bupivacaine liposome: A long-acting liposomal bupivacaine
Overall Study STARTED	25	25
Overall Study COMPLETED	24	25
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Hip Fracture Exparel Administration Trial Capsule During Hemiarthroplasty

Baseline characteristics by cohort

Measure	Saline n=24 Participants This arm will receive Saline along with Bupivacaine Saline: Saline injection used as control	Bupivacaine Liposome n=25 Participants This arm will receive Exparel along with Bupivacaine Bupivacaine liposome: A long-acting liposomal bupivacaine	Total n=49 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	24 Participants n=5 Participants	25 Participants n=7 Participants	49 Participants n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	18 Participants n=7 Participants	38 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants	23 Participants n=7 Participants	39 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	24 participants n=5 Participants	25 participants n=7 Participants	49 participants n=5 Participants

PRIMARY outcome

Timeframe: 4hrs after surgery

Primary outcome measure will be postoperative visual analogue scale (VAS from 0-10) pain scores. 0 = no pain, 10 = most pain

Outcome measures

Measure	Saline n=24 Participants This arm will receive Saline along with Bupivacaine Saline: Saline injection used as control	Bupivacaine Liposome n=25 Participants This arm will receive Exparel along with Bupivacaine Bupivacaine liposome: A long-acting liposomal bupivacaine
Post-operative Pain	3.29 score on a scale Standard Deviation 2.66	2.64 score on a scale Standard Deviation 2.27

PRIMARY outcome

Timeframe: 8hrs after surgery

Primary outcome measure will be postoperative visual analogue scale (VAS from 0-10) pain scores. 0 = no pain, 10 = most pain

Outcome measures

Measure	Saline n=24 Participants This arm will receive Saline along with Bupivacaine Saline: Saline injection used as control	Bupivacaine Liposome n=25 Participants This arm will receive Exparel along with Bupivacaine Bupivacaine liposome: A long-acting liposomal bupivacaine
Post-operative Pain	3.04 score on a scale Standard Deviation 1.64	2.12 score on a scale Standard Deviation 1.79

PRIMARY outcome

Timeframe: 12hrs after surgery

Primary outcome measure will be postoperative visual analogue scale (VAS from 0-10) pain scores. 0 = no pain, 10 = most pain

Outcome measures

Measure	Saline n=24 Participants This arm will receive Saline along with Bupivacaine Saline: Saline injection used as control	Bupivacaine Liposome n=25 Participants This arm will receive Exparel along with Bupivacaine Bupivacaine liposome: A long-acting liposomal bupivacaine
Post-operative Pain	2.42 score on a scale Standard Deviation 2.19	2.08 score on a scale Standard Deviation 2.72

PRIMARY outcome

Timeframe: 24hrs after surgery

Primary outcome measure will be postoperative visual analogue scale (VAS from 0-10) pain scores. 0 = no pain, 10 = most pain

Outcome measures

Measure	Saline n=24 Participants This arm will receive Saline along with Bupivacaine Saline: Saline injection used as control	Bupivacaine Liposome n=25 Participants This arm will receive Exparel along with Bupivacaine Bupivacaine liposome: A long-acting liposomal bupivacaine
Post-operative Pain	2.58 score on a scale Standard Deviation 2.86	2.00 score on a scale Standard Deviation 2.48

PRIMARY outcome

Timeframe: 48hrs after surgery

Primary outcome measure will be postoperative visual analogue scale (VAS from 0-10) pain scores. 0 = no pain, 10 = most pain

Outcome measures

Measure	Saline n=24 Participants This arm will receive Saline along with Bupivacaine Saline: Saline injection used as control	Bupivacaine Liposome n=25 Participants This arm will receive Exparel along with Bupivacaine Bupivacaine liposome: A long-acting liposomal bupivacaine
Post-operative Pain	2.71 score on a scale Standard Deviation 3.10	2.04 score on a scale Standard Deviation 2.69

SECONDARY outcome

Timeframe: 24 and 48 hours after surgery

Measure of time to ambulation with physical therapy

Outcome measures

Measure	Saline n=24 Participants This arm will receive Saline along with Bupivacaine Saline: Saline injection used as control	Bupivacaine Liposome n=25 Participants This arm will receive Exparel along with Bupivacaine Bupivacaine liposome: A long-acting liposomal bupivacaine
Time to Ambulation	1.44 Days Standard Deviation 0.82	1.12 Days Standard Deviation 0.53

SECONDARY outcome

Timeframe: 48 hours after surgery

Total dose in milligrams of opiates measured in total morphine equivalents. This was measured by calculating the sum of total morphine equivalents administered within 48 hours postoperatively. Assessed at 12, 24, 36, 48 hours after surgery, total postoperative total morphine equivalents at 48 hours after surgery reported

Outcome measures

Measure	Saline n=24 Participants This arm will receive Saline along with Bupivacaine Saline: Saline injection used as control	Bupivacaine Liposome n=25 Participants This arm will receive Exparel along with Bupivacaine Bupivacaine liposome: A long-acting liposomal bupivacaine
Postoperative Total Morphine Equivalent	9.98 Morphine Equivalent Standard Deviation 10.638927	12.09 Morphine Equivalent Standard Deviation 9.65

SECONDARY outcome

Timeframe: 24 and 48 hours after surgery

Assessment of post-operative delirium based on Short Confusion Assessment Method

Outcome measures

Measure	Saline n=24 Participants This arm will receive Saline along with Bupivacaine Saline: Saline injection used as control	Bupivacaine Liposome n=25 Participants This arm will receive Exparel along with Bupivacaine Bupivacaine liposome: A long-acting liposomal bupivacaine
Delirium Scale Measurements At 24 Hours	0 Participants	1 Participants
Delirium Scale Measurements At 48 Hours	0 Participants	0 Participants
Delirium Scale Measurements No Delirium	24 Participants	24 Participants

SECONDARY outcome

Timeframe: 7 days from day of admission

Total days until discharge from hospital

Outcome measures

Measure	Saline n=24 Participants This arm will receive Saline along with Bupivacaine Saline: Saline injection used as control	Bupivacaine Liposome n=25 Participants This arm will receive Exparel along with Bupivacaine Bupivacaine liposome: A long-acting liposomal bupivacaine
Length of Stay	3.88 Days Standard Deviation 2.13	3.92 Days Standard Deviation 1.44

Adverse Events

Saline

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Bupivacaine Liposome

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. Kevin Kang

Maimonides Medical Center

Phone: 718-283-8805

Email: kkang@maimonidesmed.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place