Trial Outcomes & Findings for Liposomal Bupivacaine for Post Operative Pain After Knee Replacement Surgery (NCT NCT02274870)

NCT ID: NCT02274870

Last Updated: 2018-06-14

Results Overview

Pain intensity at maximum knee flexion measured using a 0-10 visual analog scale. Higher values represent a higher pain intensity or worse outcome.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 65 participants
• Primary outcome timeframe: 24hrs
• Results posted on: 2018-06-14

Participant Flow

Participant milestones

Measure	Liposomal Bupivacaine Liposomal Bupivacaine 266mg Knee Infiltration Liposomal Bupivacaine: administered via local tissue infiltration around the knee joint.	Bupivacaine HCl Bupivacaine HCl Continuous Femoral Nerve Block (CFNB), bolus and continuous for 48 hrs) Bupivacaine HCl: Administered via CFNB
Overall Study STARTED	32	33
Overall Study COMPLETED	32	33
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Liposomal Bupivacaine for Post Operative Pain After Knee Replacement Surgery

Baseline characteristics by cohort

Measure	Liposomal Bupivacaine, n=32 Participants Liposomal Bupivacaine 266mg, Knee Infiltration Liposomal Bupivacaine: administered via local tissue infiltration around the knee joint.	Bupivacaine HCl n=33 Participants Bupivacaine HCl Continuous Femoral Nerve Block (CFNB), bolus and continuous for 48 hrs) Bupivacaine HCl: Administered via CFNB.	Total n=65 Participants Total of all reporting groups
Age, Continuous	64.19 years STANDARD_DEVIATION 7.59 • n=5 Participants	62.29 years STANDARD_DEVIATION 8.11 • n=7 Participants	63.22 years STANDARD_DEVIATION 7.86 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	21 Participants n=7 Participants	35 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	12 Participants n=7 Participants	30 Participants n=5 Participants
Region of Enrollment United States	32 Count of Participants n=5 Participants	33 Count of Participants n=7 Participants	65 Count of Participants n=5 Participants
BMI, Continuous	33.13 kg/m^2 STANDARD_DEVIATION 4.53 • n=5 Participants	32.57 kg/m^2 STANDARD_DEVIATION 4.55 • n=7 Participants	32.84 kg/m^2 STANDARD_DEVIATION 4.52 • n=5 Participants

PRIMARY outcome

Timeframe: 24hrs

Pain intensity at maximum knee flexion measured using a 0-10 visual analog scale.

Higher values represent a higher pain intensity or worse outcome.

Outcome measures

Measure	Liposomal Bupivacaine, n=32 Participants Liposomal Bupivacaine 266mg, Knee Infiltration Liposomal Bupivacaine: Administered via local tissue infiltration around the knee joint	Bupivacaine HCl n=33 Participants Bupivacaine HCl Continuous Femoral Nerve Block (CFNB), bolus and continuous for 48 hrs) Bupivacaine HCl: Administered via CFNB
Pain Intensity at Movement	8.95 VAS Scale Interval 8.42 to 9.48	7.91 VAS Scale Interval 7.19 to 8.61

SECONDARY outcome

Timeframe: 24hrs

Pain intensity at maximum knee flexion measured using a 0-10 visual analog scale.

Higher values represent a higher pain intensity or worse outcome.

Outcome measures

Measure	Liposomal Bupivacaine, n=32 Participants Liposomal Bupivacaine 266mg, Knee Infiltration Liposomal Bupivacaine: Administered via local tissue infiltration around the knee joint	Bupivacaine HCl n=33 Participants Bupivacaine HCl Continuous Femoral Nerve Block (CFNB), bolus and continuous for 48 hrs) Bupivacaine HCl: Administered via CFNB
Pain Intensity at Rest	5.08 VAS Scale Interval 4.18 to 5.98	5.16 VAS Scale Interval 4.17 to 6.14

SECONDARY outcome

Timeframe: 24hrs

Outcome measures

Measure	Liposomal Bupivacaine, n=32 Participants Liposomal Bupivacaine 266mg, Knee Infiltration Liposomal Bupivacaine: Administered via local tissue infiltration around the knee joint	Bupivacaine HCl n=33 Participants Bupivacaine HCl Continuous Femoral Nerve Block (CFNB), bolus and continuous for 48 hrs) Bupivacaine HCl: Administered via CFNB
Opioid Consumption	28.91 Morphine milligram equivalents Interval 22.11 to 35.7	26.32 Morphine milligram equivalents Interval 20.6 to 32.03

SECONDARY outcome

Timeframe: 72hrs

Population: Of the 32 and 33 participants in each arm 11 and 12 were allocated respectively to receive a blood draw

Outcome measures

Measure	Liposomal Bupivacaine, n=11 Participants Liposomal Bupivacaine 266mg, Knee Infiltration Liposomal Bupivacaine: Administered via local tissue infiltration around the knee joint	Bupivacaine HCl n=12 Participants Bupivacaine HCl Continuous Femoral Nerve Block (CFNB), bolus and continuous for 48 hrs) Bupivacaine HCl: Administered via CFNB
Mean Plasma Bupivicaine Level	0.04 microgram per mL Standard Deviation 0.01	1.08 microgram per mL Standard Deviation 0.40

SECONDARY outcome

Timeframe: 48hrs

Population: Of the 32 and 33 participants in each arm 11 and 12 were allocated respectively to receive a blood draw

Outcome measures

Measure	Liposomal Bupivacaine, n=11 Participants Liposomal Bupivacaine 266mg, Knee Infiltration Liposomal Bupivacaine: Administered via local tissue infiltration around the knee joint	Bupivacaine HCl n=12 Participants Bupivacaine HCl Continuous Femoral Nerve Block (CFNB), bolus and continuous for 48 hrs) Bupivacaine HCl: Administered via CFNB
Mean Plasma Bupivacaine Levels	0.29 microgram per mL Standard Deviation 0.19	1.76 microgram per mL Standard Deviation 0.53

SECONDARY outcome

Timeframe: 24hrs

Population: Of the 32 and 33 participants in each arm 11 and 12 were allocated respectively to receive a blood draw

Outcome measures

Measure	Liposomal Bupivacaine, n=11 Participants Liposomal Bupivacaine 266mg, Knee Infiltration Liposomal Bupivacaine: Administered via local tissue infiltration around the knee joint	Bupivacaine HCl n=12 Participants Bupivacaine HCl Continuous Femoral Nerve Block (CFNB), bolus and continuous for 48 hrs) Bupivacaine HCl: Administered via CFNB
Mean Plasma Bupivacaine Level	0.5 microgram per mL Standard Deviation 0.16	1.16 microgram per mL Standard Deviation 0.40

SECONDARY outcome

Timeframe: 12hrs

Population: Of the 32 and 33 participants in each arm 11 and 12 were allocated respectively to receive a blood draw

Outcome measures

Measure	Liposomal Bupivacaine, n=11 Participants Liposomal Bupivacaine 266mg, Knee Infiltration Liposomal Bupivacaine: Administered via local tissue infiltration around the knee joint	Bupivacaine HCl n=12 Participants Bupivacaine HCl Continuous Femoral Nerve Block (CFNB), bolus and continuous for 48 hrs) Bupivacaine HCl: Administered via CFNB
Mean Plasma Bupivacaine Level	0.49 microgram per mL Standard Deviation 0.23	0.74 microgram per mL Standard Deviation 0.25

SECONDARY outcome

Timeframe: 4hrs

Population: Of the 32 and 33 participants in each arm 11 and 12 were allocated respectively to receive a blood draw

Outcome measures

Measure	Liposomal Bupivacaine, n=11 Participants Liposomal Bupivacaine 266mg, Knee Infiltration Liposomal Bupivacaine: Administered via local tissue infiltration around the knee joint	Bupivacaine HCl n=12 Participants Bupivacaine HCl Continuous Femoral Nerve Block (CFNB), bolus and continuous for 48 hrs) Bupivacaine HCl: Administered via CFNB
Mean Plasma Bupivacaine Level	0.35 microgram per mL Standard Deviation 0.18	0.44 microgram per mL Standard Deviation 0.16

SECONDARY outcome

Timeframe: 2hrs

Population: Of the 32 and 33 participants in each arm 11 and 12 were allocated respectively to receive a blood draw

Outcome measures

Measure	Liposomal Bupivacaine, n=11 Participants Liposomal Bupivacaine 266mg, Knee Infiltration Liposomal Bupivacaine: Administered via local tissue infiltration around the knee joint	Bupivacaine HCl n=12 Participants Bupivacaine HCl Continuous Femoral Nerve Block (CFNB), bolus and continuous for 48 hrs) Bupivacaine HCl: Administered via CFNB
Mean Plasma Bupivacaine Level	0.24 microgram per mL Standard Deviation 0.1	0.29 microgram per mL Standard Deviation 0.15

SECONDARY outcome

Timeframe: Baseline

Population: Of the 32 and 33 participants in each arm 11 and 12 were allocated respectively to receive a blood draw

Outcome measures

Measure	Liposomal Bupivacaine, n=11 Participants Liposomal Bupivacaine 266mg, Knee Infiltration Liposomal Bupivacaine: Administered via local tissue infiltration around the knee joint	Bupivacaine HCl n=12 Participants Bupivacaine HCl Continuous Femoral Nerve Block (CFNB), bolus and continuous for 48 hrs) Bupivacaine HCl: Administered via CFNB
Mean Plasma Bupivacaine Level	0.1 microgram per mL Interval 0.1 to 0.1	0.1 microgram per mL Interval 0.1 to 0.1

Adverse Events

Liposomal Bupivacaine

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Bupivacaine HCl

Serious events: 0 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Liposomal Bupivacaine n=32 participants at risk Liposomal Bupivacaine 266mg, Knee Infiltration Liposomal Bupivacaine: Administered via local tissue infiltration around the knee joint	Bupivacaine HCl n=33 participants at risk Bupivacaine HCl Continuous Femoral Nerve Block (CFNB), bolus and continuous for 48 hrs) Bupivacaine HCl: Administered via CFNB
Gastrointestinal disorders PONV	21.9% 7/32	30.3% 10/33
Nervous system disorders Hypotension	3.1% 1/32	24.2% 8/33
Cardiac disorders Chest Pains	0.00% 0/32	3.0% 1/33
General disorders Somnolence	9.4% 3/32	9.1% 3/33
Skin and subcutaneous tissue disorders Diaphoresis	3.1% 1/32	3.0% 1/33
Injury, poisoning and procedural complications Knee Swelling	6.2% 2/32	3.0% 1/33
General disorders headache	6.2% 2/32	3.0% 1/33

Additional Information

Director of Research, Anesthesiology

Northwell Health

Phone: 718-470-7630

Email: odowling@northwell.edu

Results disclosure agreements

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