Bupivacaine Liposome Suspension Versus a Concentrated Multi Drug Periarticular Injection

NCT ID: NCT02299349

Last Updated: 2018-10-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2014-03-31

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.

Detailed Description

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.

Conditions

Total Knee Arthroplasty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

bupivacaine liposome suspension

bupivacaine liposome suspension periarticular injection

Group Type: EXPERIMENTAL

bupivacaine liposome suspension

Intervention Type: DRUG

bupivacaine liposome suspension periarticular injection

concentrated multi drug injection

concentrated multi drug periarticular injection

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DRUG

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

Interventions

bupivacaine liposome suspension

bupivacaine liposome suspension periarticular injection

Intervention Type: DRUG

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

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

Intervention Type: DRUG

Other Intervention Names

Exparel; Ketorlac, Morphine PF, Epinephrine, Ropivicaine, 0.9% NaCL

Eligibility Criteria

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

TriHealth Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

13055-13-034

Identifier Type: -

Identifier Source: org_study_id