Liposomal Bupivacaine for Post Operative Pain After Knee Replacement Surgery

Liposomal Bupivacaine for Total Knee Arthroplasty Postoperative Analgesia

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02274870

Enrollment

Registered

2014-10-24

Start date

2014-11-30

Completion date

2017-01-31

Last updated

2018-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-operative Pain

Brief summary

Continuous femoral nerve blocks (CFNB) provide effective pain control to patients undergoing total knee replacement (TKR). However the resulting motor blockade can lead to decreased quadriceps muscle strength and delayed functional recovery.The purpose of this study is to compare the effect of Liposome Bupivacaine infiltration into the knee to CFNB on pain control and functional recovery

Detailed description

This is a prospective, randomized, active controlled study in patients undergoing total knee replacement. The objective of this study is to compare the efficacy of Liposome Bupivacaine, in managing postoperative pain, to standard of care CFNB. Following informed consent, patients will be randomized to one of two groups, Liposome Bupivacaine or active control, CFNB group. 266 mg Liposome Bupivacaine plus Bupivicaine HCL (150mg) will be administered via local joint infiltration around the knee joint prior to wound closure. In the control group a CFNB will be placed for 48hrs prior to surgery. Outcomes measured included pain at rest, movement and quadriceps muscle strength on the first and second postoperative day. It is hypothesized that Liposome Bupivacaine will provide effective pain control and improved preservation of quadriceps muscle strength, in comparison to CFNB.

Interventions

DRUGLiposome Bupivacaine

Administered via local tissue infiltration around the knee joint

DRUGBupivacaine HCl

Administered via CFNB

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 74 Years

Healthy volunteers

Inclusion criteria

* ASA Status I-III * Scheduled to undergo primary unilateral total knee arthroplasty

Exclusion criteria

* Patients who are pregnant or nursing * Alcohol or narcotic dependence within the last 2 years * Condition requiring regular use of analgesia that may confound post surgical assessments as determined by principle investigator * BMI \> 40kg/m2 * Contraindication to acetaminophen, morphine, oxycodone, ketorolac, epinephrine, or pathological conditions potentially aggravated by epinephrine * Allergies to amide-type local anesthetics * Any disease condition or lab result that could complicate a patients postoperative recovery * History of hypotension * Abnormal liver, renal or cardiac function * Other physical, mental or medical conditions that, in the opinion of the investigator, make study participation inadvisable.

Design outcomes

Primary

Measure	Time frame	Description
Pain Intensity at Movement	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.

Secondary

Measure	Time frame	Description
Pain Intensity at Rest	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.
Opioid Consumption	24hrs	—
Mean Plasma Bupivicaine Level	72hrs	—
Mean Plasma Bupivacaine Levels	48hrs	—
Mean Plasma Bupivacaine Level	24hrs	—

Countries

United States

Participant flow

Participants by arm

Arm	Count
Liposomal Bupivacaine, Liposomal Bupivacaine 266mg, Knee Infiltration Liposomal Bupivacaine: administered via local tissue infiltration around the knee joint.	32
Bupivacaine HCl Bupivacaine HCl Continuous Femoral Nerve Block (CFNB), bolus and continuous for 48 hrs) Bupivacaine HCl: Administered via CFNB.	33
Total	65

Baseline characteristics

Characteristic	Liposomal Bupivacaine,	Bupivacaine HCl	Total
Age, Continuous	64.19 years STANDARD_DEVIATION 7.59	62.29 years STANDARD_DEVIATION 8.11	63.22 years STANDARD_DEVIATION 7.86
BMI, Continuous	33.13 kg/m^2 STANDARD_DEVIATION 4.53	32.57 kg/m^2 STANDARD_DEVIATION 4.55	32.84 kg/m^2 STANDARD_DEVIATION 4.52
Region of Enrollment United States	32 Count of Participants	33 Count of Participants	65 Count of Participants
Sex: Female, Male Female	14 Participants	21 Participants	35 Participants
Sex: Female, Male Male	18 Participants	12 Participants	30 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 32	0 / 33
other Total, other adverse events	16 / 32	25 / 33
serious Total, serious adverse events	0 / 32	0 / 33

Outcome results

Primary

Pain Intensity at Movement

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

Time frame: 24hrs

Arm	Measure	Value (MEAN)
Liposomal Bupivacaine,	Pain Intensity at Movement	8.95 VAS Scale
Bupivacaine HCl	Pain Intensity at Movement	7.91 VAS Scale

Secondary