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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00737139
Recruitment Status : Terminated (Prohibitively expensive and efficacy of tranexamic acid rendered topic clinically less relevant.)
First Posted : August 18, 2008
Last Update Posted : August 31, 2012
Information provided by (Responsible Party):
Craig J Delle Valle, Rush University Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Procedure: Peri-articular injection of marcaine/epinephrine Procedure: Peri-articular injection of marcaine alone Not Applicable

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  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2008
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00737139

United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Rush University Medical Center
Principal Investigator: Craig J. Della Valle, MD Rush University Medical Center, Department of Orthopaedics

Responsible Party: Craig J Delle Valle, MD, Rush University Medical Center Identifier: NCT00737139     History of Changes
Other Study ID Numbers: CDV-08012802
First Posted: August 18, 2008    Key Record Dates
Last Update Posted: August 31, 2012
Last Verified: August 2012

Keywords provided by Craig J Delle Valle, Rush University Medical Center:

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Epinephryl borate
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Vasoconstrictor Agents