Title
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
Phase
Phase 4Lead Sponsor
Kootenai HealthStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Total Hip and Knee ArthroplastyIntervention/Treatment
ketorolac ropivacaine epinephrine levobupivacaine bupivacaine clonidine ...Study Participants
239This 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.
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.
Periarticular injection
Periarticular injection
Included as an element of the Liposomal bupivacaine intervention periarticular injection
Included as an element of both interventions as a standard of care periarticular injection
Included as an element of both interventions as a standard of care periarticular injection
Included as an element of both interventions as a standard of care periarticular injection
Liposomal bupivacaine Bupivacaine Clonidine Epinephrine Ketorolac
Ropivacaine Clonidine Epinephrine Ketorolac
Liposomal bupivacaine Bupivacaine Clonidine Epinephrine Ketorolac
Ropivacaine Clonidine Epinephrine Ketorolac
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
| Event Type | Organ System | Event Term |
|---|
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.
Total amount of narcotics administered as calculated in oral morphine equivalent dose immediate post operatively up to 48 hours.
Measured in hours
