Bupivacaine Liposome Suspension Versus a Concentrated Multi Drug Periarticular Injection

NCT02299349 | Completed Results

• 1 other identifier: 13055-13-034
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

• Pain Scores (Visual Analog Pain Scores)

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

  1 day following surgery

Secondary Outcomes (1)

• MS04 Equivalent Consumption

  1 day following surgery

Study Arms (2)

bupivacaine liposome suspension

EXPERIMENTAL

bupivacaine liposome suspension periarticular injection

Drug: bupivacaine liposome suspension

concentrated multi drug injection

ACTIVE COMPARATOR

concentrated multi drug periarticular injection

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

Interventions

bupivacaine liposome suspension DRUG

bupivacaine liposome suspension periarticular injection

Also known as: Exparel

bupivacaine liposome suspension

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

Also known as: Ketorlac, Morphine PF, Epinephrine, Ropivicaine, 0.9% NaCL

concentrated multi drug injection

Eligibility Criteria

• Age: 35 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• TKA candidacy
• Osteoarthritis
• Failure of non-operative treatments to control knee pain

You may not qualify if:

• 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

Sponsors & Collaborators

• TriHealth Inc.: lead

MeSH Terms

Interventions

Epinephrine

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: Angela N Fellner PhD CCRP
• Organization: TriHealth Hatton Research Institute

Angie_Fellner@trihealth.com

513-862-2330

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2014
• First Posted: November 24, 2014
• Study Start: August 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: March 1, 2014
• Last Updated: October 9, 2018
• Results First Posted: April 15, 2015

Record last verified: 2017-03