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

NCT ID: NCT02543801

Last Updated: 2019-10-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 239 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-25
• Study Completion Date: 2018-08-21

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Hip Cohort Liposomal Bupivacaine

Liposomal bupivacaine Bupivacaine Clonidine Epinephrine Ketorolac

Group Type: ACTIVE_COMPARATOR

Liposomal Bupivacaine

Intervention Type: DRUG

Periarticular injection

Bupivacaine

Intervention Type: DRUG

Included as an element of the Liposomal bupivacaine intervention periarticular injection

Clonidine

Intervention Type: DRUG

Included as an element of both interventions as a standard of care periarticular injection

Ketorolac

Intervention Type: DRUG

Included as an element of both interventions as a standard of care periarticular injection

Epinephrine

Intervention Type: DRUG

Included as an element of both interventions as a standard of care periarticular injection

Hip Cohort Ropivacaine

Ropivacaine Clonidine Epinephrine Ketorolac

Group Type: ACTIVE_COMPARATOR

Ropivacaine

Intervention Type: DRUG

Periarticular injection

Clonidine

Intervention Type: DRUG

Included as an element of both interventions as a standard of care periarticular injection

Ketorolac

Intervention Type: DRUG

Included as an element of both interventions as a standard of care periarticular injection

Epinephrine

Intervention Type: DRUG

Included as an element of both interventions as a standard of care periarticular injection

Knee Cohort Liposomal Bupivacaine

Liposomal bupivacaine Bupivacaine Clonidine Epinephrine Ketorolac

Group Type: ACTIVE_COMPARATOR

Liposomal Bupivacaine

Intervention Type: DRUG

Periarticular injection

Bupivacaine

Intervention Type: DRUG

Included as an element of the Liposomal bupivacaine intervention periarticular injection

Clonidine

Intervention Type: DRUG

Included as an element of both interventions as a standard of care periarticular injection

Ketorolac

Intervention Type: DRUG

Included as an element of both interventions as a standard of care periarticular injection

Epinephrine

Intervention Type: DRUG

Included as an element of both interventions as a standard of care periarticular injection

Knee Cohort Ropivacaine

Ropivacaine Clonidine Epinephrine Ketorolac

Group Type: ACTIVE_COMPARATOR

Ropivacaine

Intervention Type: DRUG

Periarticular injection

Clonidine

Intervention Type: DRUG

Included as an element of both interventions as a standard of care periarticular injection

Ketorolac

Intervention Type: DRUG

Included as an element of both interventions as a standard of care periarticular injection

Epinephrine

Intervention Type: DRUG

Included as an element of both interventions as a standard of care periarticular injection

Interventions

Liposomal Bupivacaine

Periarticular injection

Intervention Type: DRUG

Ropivacaine

Periarticular injection

Intervention Type: DRUG

Bupivacaine

Included as an element of the Liposomal bupivacaine intervention periarticular injection

Intervention Type: DRUG

Clonidine

Included as an element of both interventions as a standard of care periarticular injection

Intervention Type: DRUG

Ketorolac

Included as an element of both interventions as a standard of care periarticular injection

Intervention Type: DRUG

Epinephrine

Included as an element of both interventions as a standard of care periarticular injection

Intervention Type: DRUG

Other Intervention Names

Exparel; Naropin; Marcaine; Duraclon; Toradol; Adrenaline

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kootenai Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joe Bowen, MD

Role: PRINCIPAL_INVESTIGATOR

Kootenai Health

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB2022

Identifier Type: -

Identifier Source: org_study_id