Trial Outcomes & Findings for Bupivacaine Liposome Suspension Versus a Concentrated Multi Drug Periarticular Injection (NCT NCT02299349)

Results Overview

visual analog pain scores (scale 0=no pain; 10=worst pain imaginable)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

70 participants

Primary outcome timeframe

1 day following surgery

Results posted on

2018-10-09

Participant Flow

Participant milestones

Participant milestones
Measure	Bupivacaine Liposome Suspension bupivacaine liposome suspension periarticular injection bupivacaine liposome suspension: bupivacaine liposome suspension periarticular injection	Concentrated Multi Drug Injection concentrated multi drug periarticular injection concentrated multi drug Ketorlac, Morphine PF, Epinephrine, Ropivicaine, 0.9% NaCL: Ketorolac 30 mg, Morphine PF 5 mg, Epinephrine 0.6 mg, Ropivacaine 400 mg, QS to 100ml with 0.9% NaCl
Overall Study STARTED	35	35
Overall Study COMPLETED	35	35
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Bupivacaine Liposome Suspension Versus a Concentrated Multi Drug Periarticular Injection

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bupivacaine Liposome Suspension n=35 Participants bupivacaine liposome suspension periarticular injection bupivacaine liposome suspension: bupivacaine liposome suspension periarticular injection	Concentrated Multi Drug Injection n=35 Participants concentrated multi drug periarticular injection concentrated multi drug Ketorlac, Morphine PF, Epinephrine, Ropivicaine, 0.9% NaCL: Ketorolac 30 mg, Morphine PF 5 mg, Epinephrine 0.6 mg, Ropivacaine 400 mg, QS to 100ml with 0.9% NaCl	Total n=70 Participants Total of all reporting groups
Age, Continuous	67.3 years STANDARD_DEVIATION 10.3 • n=5 Participants	65.6 years STANDARD_DEVIATION 7.9 • n=7 Participants	66.4 years STANDARD_DEVIATION 9.1 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	20 Participants n=7 Participants	33 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	15 Participants n=7 Participants	37 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	35 participants n=5 Participants	34 participants n=7 Participants	69 participants n=5 Participants
Race/Ethnicity, Customized African American	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 day following surgery

visual analog pain scores (scale 0=no pain; 10=worst pain imaginable)

Outcome measures

Outcome measures
Measure	Bupivacaine Liposome Suspension n=35 Participants bupivacaine liposome suspension periarticular injection bupivacaine liposome suspension: bupivacaine liposome suspension periarticular injection	Concentrated Multi Drug Injection n=35 Participants concentrated multi drug periarticular injection concentrated multi drug Ketorlac, Morphine PF, Epinephrine, Ropivicaine, 0.9% NaCL: Ketorolac 30 mg, Morphine PF 5 mg, Epinephrine 0.6 mg, Ropivacaine 400 mg, QS to 100ml with 0.9% NaCl
Pain Scores (Visual Analog Pain Scores)	2.6 units on a scale Standard Deviation 1.27	3.3 units on a scale Standard Deviation 1.55

SECONDARY outcome

Timeframe: 1 day following surgery

in hospital total MS04 equivalent consumption

Outcome measures

Outcome measures
Measure	Bupivacaine Liposome Suspension n=35 Participants bupivacaine liposome suspension periarticular injection bupivacaine liposome suspension: bupivacaine liposome suspension periarticular injection	Concentrated Multi Drug Injection n=35 Participants concentrated multi drug periarticular injection concentrated multi drug Ketorlac, Morphine PF, Epinephrine, Ropivicaine, 0.9% NaCL: Ketorolac 30 mg, Morphine PF 5 mg, Epinephrine 0.6 mg, Ropivacaine 400 mg, QS to 100ml with 0.9% NaCl
MS04 Equivalent Consumption	10.0 mg Interval 5.0 to 15.0	15.0 mg Interval 8.0 to 20.0

Adverse Events

Bupivacaine Liposome Suspension

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Concentrated Multi Drug Injection

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

Angela N Fellner PhD CCRP

TriHealth Hatton Research Institute

Phone: 513-862-2330

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place