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Completed

NCT Number: NCT02274870

Liposomal Bupivacaine for Post Operative Pain After Knee Replacement Surgery

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

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Key information

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Franklin

Valley Stream, New York, 11580, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

liposome bupivacaine

Drug

Administered via local tissue infiltration around the knee joint

Other names: Bupivacaine Liposome, Injectable Suspension

Bupivacaine HCl

Drug

Administered via CFNB

Other names: Standard of Care

Primary outcomes

  1. Pain Intensity at Movement

    Time frame: 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 outcomes

  1. Pain Intensity at Rest

    Time frame: 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.

  2. Opioid Consumption

    Time frame: 24hrs

  3. Mean Plasma Bupivicaine Level

    Time frame: 72hrs

  4. Mean Plasma Bupivacaine Levels

    Time frame: 48hrs

  5. Mean Plasma Bupivacaine Level

    Time frame: 24hrs

  6. Mean Plasma Bupivacaine Level

    Time frame: 12hrs

  7. Mean Plasma Bupivacaine Level

    Time frame: 4hrs

  8. Mean Plasma Bupivacaine Level

    Time frame: 2hrs

  9. Mean Plasma Bupivacaine Level

    Time frame: Baseline

Sponsors and collaborators

Lead sponsor

Northwell Health

Other

Registry information

Official study title

Liposomal Bupivacaine for Total Knee Arthroplasty Postoperative Analgesia

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Oct 24, 2014
Registry last updated
Jun 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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