Trial Outcomes & Findings for Liposomal Bupivacaine With Bupivacaine in Ankle Fracture Open Reduction Internal Fixation (ORIF) (NCT NCT02480621)

Last Updated: 2017-10-20

Results Overview

A Visual Analog Scale (VAS) ranging from 0 to 10 in increments of 1 was used to both qualitatively and quantitatively assess the level and severity of pain during the time points ranging from the immediate post-operative period through 72 hours post-operative. Each number on the scale is accompanied by a visual facial expression that indicates the level of pain, discomfort, and distress appropriate to the number on the scale. The more severe the level of pain, the higher the corresponding number and more distressing the accompanying facial expression. A VAS score of 0 indicates no active pain level and is accompanied by a pleasantly smiling face whereas a VAS score of 10 indicates the most severe active pain level and is accompanied by a visibly-distraught face that is frowning, grimacing, and sweating. The combination of facial expressions and numbers is supposed to provide a language-independent, validated means of assessing pain levels.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

84 participants

Primary outcome timeframe

Immediate post-operative period until 72 hours post-operatively

Results posted on

2017-10-20

Participant Flow

Participant milestones

Participant milestones
Measure	Control Standard of care: Open Reduction Internal Fixation with no injection of pain medications around the affected ankle, but these control patients did receive a local intra-operative injection saline while under general anesthesia	Liposomal Bupivacaine With Bupivacaine Intra-operatively, patients receive a local injection of liposomal bupivacaine with bupivacaine around the affected ankle. Liposomal Bupivacaine with Bupivacaine: Pain medications injected locally during surgery around affected ankle.
Randomization STARTED	44	40
Randomization COMPLETED	43	39
Randomization NOT COMPLETED	1	1
Follow Up STARTED	43	39
Follow Up COMPLETED	39	37
Follow Up NOT COMPLETED	4	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Control Standard of care: Open Reduction Internal Fixation with no injection of pain medications around the affected ankle, but these control patients did receive a local intra-operative injection saline while under general anesthesia	Liposomal Bupivacaine With Bupivacaine Intra-operatively, patients receive a local injection of liposomal bupivacaine with bupivacaine around the affected ankle. Liposomal Bupivacaine with Bupivacaine: Pain medications injected locally during surgery around affected ankle.
Randomization Withdrawal by Subject	1	0
Randomization Surgeon did not give intervention	0	1
Follow Up Lost to Follow-up	4	2

Baseline Characteristics

Liposomal Bupivacaine With Bupivacaine in Ankle Fracture Open Reduction Internal Fixation (ORIF)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control n=39 Participants Standard of care: Open Reduction Internal Fixation with no injection of pain medications around the affected ankle, but these control patients did receive a local intra-operative injection saline while under general anesthesia	Liposomal Bupivacaine With Bupivacaine n=37 Participants Intra-operatively, patients receive a local injection of liposomal bupivacaine with bupivacaine around the affected ankle. Liposomal Bupivacaine with Bupivacaine: Pain medications injected locally during surgery around affected ankle.	Total n=76 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	38 Participants n=5 Participants	32 Participants n=7 Participants	70 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants
Age, Continuous	42.6 years n=5 Participants	41.9 years n=7 Participants	42 years n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	19 Participants n=7 Participants	38 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	18 Participants n=7 Participants	38 Participants n=5 Participants
Region of Enrollment United States	39 Participants n=5 Participants	37 Participants n=7 Participants	76 Participants n=5 Participants
Body Mass Index (BMI)	29.7 kilogram per meter squared n=5 Participants	29.4 kilogram per meter squared n=7 Participants	29.5 kilogram per meter squared n=5 Participants
Charlson Comorbidity Index (CCI)	0.9 units on a scale n=5 Participants	0.8 units on a scale n=7 Participants	0.88 units on a scale n=5 Participants
OTA Fracture Classification 44A	12 Participants n=5 Participants	8 Participants n=7 Participants	20 Participants n=5 Participants
OTA Fracture Classification 44B	16 Participants n=5 Participants	19 Participants n=7 Participants	35 Participants n=5 Participants
OTA Fracture Classification 44C	11 Participants n=5 Participants	10 Participants n=7 Participants	21 Participants n=5 Participants

PRIMARY outcome

Timeframe: Immediate post-operative period until 72 hours post-operatively

Outcome measures

Outcome measures
Measure	Control n=39 Participants Standard of care: Open Reduction Internal Fixation with no injection of pain medications around the affected ankle, but these control patients did receive a local intra-operative injection saline while under general anesthesia	Liposomal Bupivacaine With Bupivacaine n=37 Participants Intra-operatively, patients receive a local injection of liposomal bupivacaine with bupivacaine around the affected ankle. Liposomal Bupivacaine with Bupivacaine: Pain medications injected locally during surgery around affected ankle.
Pain Levels on a Visual Analog Scale ( VAS) 4 Hours Post-operative	7.05 units on a scale Standard Deviation 2.87	4.03 units on a scale Standard Deviation 3.50
Pain Levels on a Visual Analog Scale ( VAS) Post-operative Day 1	7.49 units on a scale Standard Deviation 1.92	6.60 units on a scale Standard Deviation 1.85
Pain Levels on a Visual Analog Scale ( VAS) Post-operative Day 2	6.64 units on a scale Standard Deviation 2.01	5.22 units on a scale Standard Deviation 1.81
Pain Levels on a Visual Analog Scale ( VAS) Post-operative Day 3	5.72 units on a scale Standard Deviation 1.91	4.08 units on a scale Standard Deviation 1.85

Adverse Events

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Liposomal Bupivacaine With Bupivacaine

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. Adam Driesman

Department of Orthopaedic Surgery, NYU Langone Orthopaedic Hospital

Phone: 2033315938

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place