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Completed

NCT Number: NCT02299349

Bupivacaine Liposome Suspension Versus a Concentrated Multi Drug Periarticular Injection

Despite a robust multimodal pain management regimen, patients undergoing total knee arthroplasty (TKA) continue to report low satisfaction with postoperative pain management. Patient satisfaction further declines with any adverse event such as a drug reaction to neuroleptic medications or a patient fall due to a femoral nerve block. A new method of pain management throughout the hospital experience is warranted to improve patient satisfaction and the possibility of related adverse events. The purpose of this study is to examine if there is a difference in post operative pain and morphine (MSO4) total consumption for hospitalized TKA patients without femoral nerve block receiving an intra-operative periarticular injection of bupivacaine liposome suspension versus a concentrated multi drug.

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Key information

Age range

35 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

The void in the literature is that while multimodal pain management reduces postoperative pain in the majority of TKA patients6-14, too many are still dissatisfied with overall pain control13 and adverse drug reactions (dizziness and somnolence) to neuroleptic medications15. Additionally, postoperative falls are greater with femoral nerve blocks16, and new neurological symptoms are associated with the block17. Bupivacaine liposome suspension periarticular injection has large scale national anecdotal support for TKA pain control with avoidance of regional block adversity. There is one recent randomized control trial in TKA patients favorably comparing periarticular injection with bupivacaine liposome suspension versus bupivacaine hydrochloride (HCL)5. To date the clinical use and published evidence most robustly supports bupivacaine liposome suspension in patients undergoing bunionectomy or hemorrhoidectomy. Additionally, in preparation for shorter hospital stays for total joint arthroplasty, a more effective and better tolerated pain management solution is needed.

Hypothesis Statement:

Hospitalized TKA patients without a pre-operative femoral nerve block will experience improved postoperative pain control and less MSO4 equivalence consumption when receiving an injection of bupivacaine liposome suspension versus concentrated multi drug.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • TKA candidacy
  • Osteoarthritis
  • Failure of non-operative treatments to control knee pain
  • Patients able to understand and agree to study inclusion

Exclusion criteria

  • Subjects have orthopaedic and medical co-morbidities that would thwart postoperative pain control such as extra-articular pathology with referred pain to the knee (spinal stenosis, neuropathy,ipsilateral hip disease)
  • Severe knee deformity
  • Post-traumatic and inflammatory arthritis
  • BMI above 40
  • Patients unable to receive multimodal pain remitting agents
  • Active knee sepsis
  • Remote sites of active infection
  • Diabetes with A1C > 7
  • ASA class > lll
  • Cardiac disease failing medical clearance
  • Severe liver disease
  • PAD with AAI < 0.75
  • Seizure disorder
  • Allergic to any pain remitting agent
  • Alcohol abuse
  • Smoking abuse

Treatment and study plan

Bupivacaine liposome suspension

Drug

bupivacaine liposome suspension periarticular injection

Other names: Exparel

concentrated multi drug Ketorlac, Morphine PF, Epinephrine, Ropivicaine, 0.9% NaCL

Drug

Ketorolac 30 mg, Morphine PF 5 mg, Epinephrine 0.6 mg, Ropivacaine 400 mg, QS to 100ml with 0.9% NaCl

Other names: Ketorlac, Morphine PF, Epinephrine, Ropivicaine, 0.9% NaCL

Primary outcomes

  1. Pain Scores (Visual Analog Pain Scores)

    Time frame: 1 day following surgery

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

Secondary outcomes

  1. MS04 Equivalent Consumption

    Time frame: 1 day following surgery

    in hospital total MS04 equivalent consumption

Sponsors and collaborators

Lead sponsor

TriHealth Inc.

Other

Registry information

Official study title

Bupivacaine Liposome Suspension Versus a Concentrated Multi Drug Periarticular Injection in 70 Patients Undergoing Total Knee Arthroplasty Without Femoral Nerve Block: a Double-blinded, Randomized Clinical Trial

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Nov 24, 2014
Registry last updated
Oct 9, 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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