NCT02543801

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 239 (actual)
• Sponsor: Kootenai Health · Academic / Other
• Sex: All
• Age: 30 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Total Hip and Knee Arthroplasty

Interventions

Type	Name	Description
DRUG	Liposomal Bupivacaine	Periarticular injection
DRUG	Ropivacaine	Periarticular injection
DRUG	Bupivacaine	Included as an element of the Liposomal bupivacaine intervention periarticular injection
DRUG	Clonidine	Included as an element of both interventions as a standard of care periarticular injection
DRUG	Ketorolac	Included as an element of both interventions as a standard of care periarticular injection
DRUG	Epinephrine	Included as an element of both interventions as a standard of care periarticular injection

Timeline

• Start date: 2016-01-25
• Primary completion: 2018-08-21
• Completion: 2018-08-21
• First posted: 2015-09-07
• Last updated: 2019-10-18
• Results posted: 2019-10-18