Study Comparing Peri-articular Injection of Bupivacaine With and Without Epinephrine

August 29, 2012 updated by: Craig J Delle Valle, Rush University Medical Center

A Prospective, Randomized, Double-Blind Controlled Clinical Trial to Evaluate the Post-Operative Blood Loss and Transfusion Rate Following Total Joint Arthroplasty With Intra-articular Injection of Bupivacaine and Epinephrine

This study involves research. The purpose of this research is to formally investigate the hemostatic efficacy of epinephrine to minimize blood loss after total joint arthroplasty. It is unclear if using intra-articular injections of epinephrine in total joint replacement is associated with a decrease in post-operative blood loss. The initial hypothesis is: the use of intra-articular injection of epinephrine is associated with decreased post-operative blood loss.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Total hip and knee arthroplasties are associated with considerable blood loss, and can conservatively range from 480 ml to 1.39 liters. Current research has focused on the prevention of allogeneic blood transfusion with the pre-operative donation and use of epoetin alfa. While the pre-operative use of epoetin alpha is associated with a substantial decrease in the rate of transfusion, there still warrants investigation into the conservation of blood volume after total joint arthroplasty.

Although epinephrine has been in use as a local hemostatic agent, the use of epinephrine injection in joint replacement is limited. The mechanism of hemostasis by epinephrine is physiologic vasoconstriction. Despite the plethora of hemostatic agents available on the market today, the rationale for the use of epinephrine in this study is the medication's mechanism of action and safety. Epinephrine's alpha receptor-mediated vasoconstriction is must be balanced with vasodilation caused by its stimulation of beta-2 receptors. The relative concentration of epinephrine determines the degree of vasoconstriction versus dilation. A better understanding of the hemostatic properties and potential of intra-articular epinephrine injection will help minimize post-operative blood loss. In turn, this may decrease the number of units transfused, increase the patient's progression in physical therapy, and shorten the hospital length of stay. The goal of this prospective, randomized, double-blinded controlled clinical trial is to compare the post-operative blood loss and transfusion rate following total joint arthroplasty with intra-articular injection of marcaine and epinephrine versus the post-operative blood loss and transfusion rate following total joint arthroplasty with intra-articular injection of marcaine alone.

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center

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

19 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients must be male or female of any race
  • Ages 18-80yr
  • Patients must be undergoing hip or knee arthroplasty
  • Patients must be able to understand and be willing to cooperate with study procedures
  • Patient must not take platelet inhibiting drugs for 10 days before surgery
  • Able to provide written and verbal informed consent
  • Preoperative hemoglobin above 12g/dl
  • Osteoarthritis as the primary indication for knee arthroplasty, and either osteoarthritis or avascular necrosis as the indication for total hip arthroplasty

Exclusion Criteria:

  • Allergy or intolerance to the study materials or medications
  • Surgical intervention during the past month for the treatment of the painful joint or its underlying etiology
  • History of any substance abuse or dependence within the last 6 months
  • Patients who have received an investigational drug or device in the past 30 days
  • Affected joint has undergone prior open surgery
  • Patient received epoetin alfa 30 days before surgery
  • Pre-operative autologous blood donation
  • Use of platelet inhibiting drugs 10 days prior to surgery

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Intra-articular Injection of Marcaine/Epinephrine
Procedure: Peri-articular injection of marcaine/epinephrine
60ml of 0.5% Bupivacaine and Epinephrine 1:200,000 Inj
Active Comparator: 2
Intra-articular Injection of Marcaine alone
Procedure: Peri-articular injection of marcaine alone
60ml of 0.5% Bupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Record the post-operative blood volume lost in a standard, non-reinfusion drain, number of transfused units received, and calculated blood loss index during the patient's hospital course.
Time Frame: Daily for 6 weeks postoperatively
Daily for 6 weeks postoperatively

Secondary Outcome Measures

Outcome Measure
Time Frame
Record of post-operative course and health maintenance to the 6 week follow-up visit. Range of motion, patient global impressions of change (PGIC) at pre-operative, immediate, 1-day, 3-day and 6-week post-operative time points.
Time Frame: Daily for 6 weeks post-operatively
Daily for 6 weeks post-operatively

Collaborators and Investigators

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

Sponsor

Rush University Medical Center

Investigators

  • Principal Investigator: Craig J. Della Valle, MD, Rush University Medical Center, Department of Orthopaedics

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

September 1, 2008

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

August 15, 2008

First Submitted That Met QC Criteria

August 15, 2008

First Posted (Estimate)

August 18, 2008

Study Record Updates

Last Update Posted (Estimate)

August 31, 2012

Last Update Submitted That Met QC Criteria

August 29, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDV-08012802

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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