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

October 16, 2019 updated by: Kootenai Health

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

239

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Hip Cohort Liposomal Bupivacaine
Liposomal bupivacaine Bupivacaine Clonidine Epinephrine Ketorolac
Drug: Liposomal Bupivacaine
Periarticular injection
Other Names:
  • Exparel
Drug: Bupivacaine
Included as an element of the Liposomal bupivacaine intervention periarticular injection
Other Names:
  • Marcaine
Drug: Clonidine
Included as an element of both interventions as a standard of care periarticular injection
Other Names:
  • Duraclon
Drug: Ketorolac
Included as an element of both interventions as a standard of care periarticular injection
Other Names:
  • Toradol
Drug: Epinephrine
Included as an element of both interventions as a standard of care periarticular injection
Other Names:
  • Adrenaline
Active Comparator: Hip Cohort Ropivacaine
Ropivacaine Clonidine Epinephrine Ketorolac
Drug: Clonidine
Included as an element of both interventions as a standard of care periarticular injection
Other Names:
  • Duraclon
Drug: Ketorolac
Included as an element of both interventions as a standard of care periarticular injection
Other Names:
  • Toradol
Drug: Epinephrine
Included as an element of both interventions as a standard of care periarticular injection
Other Names:
  • Adrenaline
Drug: Ropivacaine
Periarticular injection
Other Names:
  • Naropin
Active Comparator: Knee Cohort Liposomal Bupivacaine
Liposomal bupivacaine Bupivacaine Clonidine Epinephrine Ketorolac
Drug: Liposomal Bupivacaine
Periarticular injection
Other Names:
  • Exparel
Drug: Bupivacaine
Included as an element of the Liposomal bupivacaine intervention periarticular injection
Other Names:
  • Marcaine
Drug: Clonidine
Included as an element of both interventions as a standard of care periarticular injection
Other Names:
  • Duraclon
Drug: Ketorolac
Included as an element of both interventions as a standard of care periarticular injection
Other Names:
  • Toradol
Drug: Epinephrine
Included as an element of both interventions as a standard of care periarticular injection
Other Names:
  • Adrenaline
Active Comparator: Knee Cohort Ropivacaine
Ropivacaine Clonidine Epinephrine Ketorolac
Drug: Clonidine
Included as an element of both interventions as a standard of care periarticular injection
Other Names:
  • Duraclon
Drug: Ketorolac
Included as an element of both interventions as a standard of care periarticular injection
Other Names:
  • Toradol
Drug: Epinephrine
Included as an element of both interventions as a standard of care periarticular injection
Other Names:
  • Adrenaline
Drug: Ropivacaine
Periarticular injection
Other Names:
  • Naropin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Score
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.
Starting post operatively and then every four hours up to 48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Narcotic Consumption
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.
Starting immediately post operatively up to 48 hours
Length of Stay
Time Frame: Start of surgery to hospital discharge up to 140 hours
Measured in hours
Start of surgery to hospital discharge up to 140 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kootenai Health

Investigators

  • Principal Investigator: Joe Bowen, MD, Kootenai Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 25, 2016

Primary Completion (Actual)

August 21, 2018

Study Completion (Actual)

August 21, 2018

Study Registration Dates

First Submitted

August 21, 2015

First Submitted That Met QC Criteria

September 4, 2015

First Posted (Estimate)

September 7, 2015

Study Record Updates

Last Update Posted (Actual)

October 18, 2019

Last Update Submitted That Met QC Criteria

October 16, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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