Bupivacaine Liposome Suspension Versus a Concentrated Multi Drug Periarticular Injection

Total Knee Arthroplasty Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02299349
• Other study ID #: 13055-13-034
• Status: Completed
• Phase: N/A
• Start date: August 2013
• Est. completion date: March 2014

Study information

• Verified date: March 2017
• Source: TriHealth Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: March 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Total Knee Arthroplasty

Intervention

Drug:
• bupivacaine liposome suspension
bupivacaine liposome suspension periarticular injection
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
TriHealth Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Scores (Visual Analog Pain Scores)	visual analog pain scores (scale 0=no pain; 10=worst pain imaginable)	1 day following surgery
Secondary	MS04 Equivalent Consumption	in hospital total MS04 equivalent consumption	1 day following surgery