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

Kootenai Health

Status and phase: Completed; Phase 4

Conditions: Total Hip and Knee Arthroplasty

Treatments: Drug: Epinephrine; Drug: Liposomal Bupivacaine; Drug: Clonidine; Drug: Bupivacaine; Drug: Ropivacaine; Drug: Ketorolac

Study type: Interventional

Funder types: Other

Identifiers

NCT02543801

IRB2022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 239 patients

Sex: All

Ages: 30 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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239 participants in 4 patient groups

Hip Cohort Liposomal Bupivacaine

Active Comparator group

Description:

Liposomal bupivacaine Bupivacaine Clonidine Epinephrine Ketorolac

Treatment:

Drug: Ketorolac

Drug: Bupivacaine

Drug: Clonidine

Drug: Liposomal Bupivacaine

Drug: Epinephrine

Hip Cohort Ropivacaine

Active Comparator group

Description:

Ropivacaine Clonidine Epinephrine Ketorolac

Treatment:

Drug: Ketorolac

Drug: Ropivacaine

Drug: Clonidine

Drug: Epinephrine

Knee Cohort Liposomal Bupivacaine

Active Comparator group

Description:

Liposomal bupivacaine Bupivacaine Clonidine Epinephrine Ketorolac

Treatment:

Drug: Ketorolac

Drug: Bupivacaine

Drug: Clonidine

Drug: Liposomal Bupivacaine

Drug: Epinephrine

Knee Cohort Ropivacaine

Active Comparator group

Description:

Ropivacaine Clonidine Epinephrine Ketorolac

Treatment:

Drug: Ketorolac

Drug: Ropivacaine

Drug: Clonidine

Drug: Epinephrine