A Clinical Trial of Two Periarticular Multimodal Drug Injections in Total Hip and Knee Arthroplasty

Study Overview
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Brief Summary
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This study evaluates two routinely used drug combinations for periarticular injection following total hip and knee arthroplasty for pain control. One group will receive liposomal bupivacaine, bupivacaine, clonidine, epinephrine and ketorolac. The other group will receive ropivacaine, clonidine, epinephrine and ketorolac.

Detailed Description
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A key component of the multimodal approach to pain management is the intra-operative surgical site injection of a local anesthetic or drug cocktail. There are many formulations used for this purpose. A formulation documented in the literature was implemented by this institution which has dropped the average length of stay dramatically. Concern over the limited half-life of the administered anesthetic and the continued need for opioid administration has led to a search for better drug formulations and administration vehicles. Recently, the FDA approval of an extended release bupivacaine called liposomal bupivacaine was thought to extend the effective half-life of the anesthetic agent and thereby prolong post-operative anesthesia. Use of liposomal bupivacaine in total joint surgery was almost universally adopted after its recent approval and has been an integral part of the same day total joint movement. Studies have suggested improvement in pain control and shortened hospitalizations with the use of liposomal bupivacaine. Other studies have raised questions about the effectiveness of this agent. Recently a randomized double blind study was performed with total knees which demonstrated no improvement in pain management with the addition of liposomal bupivacaine to the multimodal pain management protocol. This study has not been performed in the hip arthroplasty population.

Official Title
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A Prospective, Randomized Clinical Trial of Two Periarticular Multimodal Drug Injections in Total Hip and Knee Arthroplasty

Conditions
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Total Hip and Knee Arthroplasty

Intervention / Treatment
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* Drug: Liposomal Bupivacaine
* Drug: Ropivacaine
* Drug: Bupivacaine
* Drug: Clonidine
* Drug: Ketorolac
* Drug: Epinephrine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hip Arthritis (osteoarthritis, post traumatic, inflammatory, and avascular necrosis) Exclusion Criteria: Current use of opioid drugs Revision surgery Surgical complication (femoral fracture with implant insertion) Inability to provide Informed Consent

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hip Cohort Liposomal Bupivacaine<br>Liposomal bupivacaine Bupivacaine Clonidine Epinephrine Ketorolac | Drug: Liposomal Bupivacaine<br>* Periarticular injection<br>* Other names: Exparel;Drug: Bupivacaine<br>* Included as an element of the Liposomal bupivacaine intervention periarticular injection<br>* Other names: Marcaine;Drug: Clonidine<br>* Included as an element of both interventions as a standard of care periarticular injection<br>* Other names: Duraclon;Drug: Ketorolac<br>* Included as an element of both interventions as a standard of care periarticular injection<br>* Other names: Toradol;Drug: Epinephrine<br>* Included as an element of both interventions as a standard of care periarticular injection<br>* Other names: Adrenaline;|
| Active Comparator: Hip Cohort Ropivacaine<br>Ropivacaine Clonidine Epinephrine Ketorolac | Drug: Ropivacaine<br>* Periarticular injection<br>* Other names: Naropin;Drug: Clonidine<br>* Included as an element of both interventions as a standard of care periarticular injection<br>* Other names: Duraclon;Drug: Ketorolac<br>* Included as an element of both interventions as a standard of care periarticular injection<br>* Other names: Toradol;Drug: Epinephrine<br>* Included as an element of both interventions as a standard of care periarticular injection<br>* Other names: Adrenaline;|
| Active Comparator: Knee Cohort Liposomal Bupivacaine<br>Liposomal bupivacaine Bupivacaine Clonidine Epinephrine Ketorolac | Drug: Liposomal Bupivacaine<br>* Periarticular injection<br>* Other names: Exparel;Drug: Bupivacaine<br>* Included as an element of the Liposomal bupivacaine intervention periarticular injection<br>* Other names: Marcaine;Drug: Clonidine<br>* Included as an element of both interventions as a standard of care periarticular injection<br>* Other names: Duraclon;Drug: Ketorolac<br>* Included as an element of both interventions as a standard of care periarticular injection<br>* Other names: Toradol;Drug: Epinephrine<br>* Included as an element of both interventions as a standard of care periarticular injection<br>* Other names: Adrenaline;|
| Active Comparator: Knee Cohort Ropivacaine<br>Ropivacaine Clonidine Epinephrine Ketorolac | Drug: Ropivacaine<br>* Periarticular injection<br>* Other names: Naropin;Drug: Clonidine<br>* Included as an element of both interventions as a standard of care periarticular injection<br>* Other names: Duraclon;Drug: Ketorolac<br>* Included as an element of both interventions as a standard of care periarticular injection<br>* Other names: Toradol;Drug: Epinephrine<br>* Included as an element of both interventions as a standard of care periarticular injection<br>* Other names: Adrenaline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Score | Self-reported pain score 0-10 (0=no pain - 10=worst possible pain experienced) and higher scores indicate a worse outcome Pain scores, collected every 4 hours per hospital care standards, were averaged (post-operatively up to 48 hours) to obtain individual mean pain scores and a mean score for the group was then calculated. | Starting post operatively and then every four hours up to 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Narcotic Consumption | Total amount of narcotics administered as calculated in oral morphine equivalent dose immediate post operatively up to 48 hours. | Starting immediately post operatively up to 48 hours | 
| Length of Stay | Measured in hours | Start of surgery to hospital discharge up to 140 hours |