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Liposomal Bupivacaine for Post Operative Pain After Knee Replacement Surgery

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Northwell Health

Status and phase

Completed
Phase 4

Conditions

Post-operative Pain

Treatments

Drug: Bupivacaine HCl
Drug: Liposome Bupivacaine

Study type

Interventional

Funder types

Other

Identifiers

NCT02274870
IRB: 14-237B

Details and patient eligibility

About

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

Full 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.

Enrollment

65 patients

Sex

All

Ages

18 to 74 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

65 participants in 2 patient groups

Liposome Bupivacaine,
Experimental group
Description:
Liposome Bupivacaine 266mg, Knee Infiltration
Treatment:
Drug: Liposome Bupivacaine
Bupivacaine HCl
Active Comparator group
Description:
Bupivacaine HCl Continuous Femoral Nerve Block (CFNB), bolus and continuous for 48 hrs)
Treatment:
Drug: Bupivacaine HCl

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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