Liposomal bupivacaine
DrugPeriarticular injection
Other names: Exparel
NCT Number: NCT02543801
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.
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Notify Me30 year–85 year
All sexes
Interventional
Phase 4
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Periarticular injection
Other names: Exparel
Periarticular injection
Other names: Naropin
Included as an element of the Liposomal bupivacaine intervention periarticular injection
Other names: Marcaine
Included as an element of both interventions as a standard of care periarticular injection
Other names: Duraclon
Included as an element of both interventions as a standard of care periarticular injection
Other names: Toradol
Included as an element of both interventions as a standard of care periarticular injection
Other names: Adrenaline
Time frame: Starting post operatively and then every four hours up to 48 hours
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.
Time frame: Starting immediately post operatively up to 48 hours
Total amount of narcotics administered as calculated in oral morphine equivalent dose immediate post operatively up to 48 hours.
Time frame: Start of surgery to hospital discharge up to 140 hours
Measured in hours
Kootenai Health
Other
A Prospective, Randomized Clinical Trial of Two Periarticular Multimodal Drug Injections in Total Hip and Knee Arthroplasty
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