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

NCT ID: NCT00737139

Last Updated: 2012-08-31

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2012-04-30

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.

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.

Conditions

Osteoarthritis

Keywords

Hip; Knee; Arthroplasty; Epinephrine; Hemostasis

Study Design

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

Study Groups

1

Intra-articular Injection of Marcaine/Epinephrine

Group Type: ACTIVE_COMPARATOR

Peri-articular injection of marcaine/epinephrine

Intervention Type: PROCEDURE

60ml of 0.5% Bupivacaine and Epinephrine 1:200,000 Inj

2

Intra-articular Injection of Marcaine alone

Group Type: ACTIVE_COMPARATOR

Peri-articular injection of marcaine alone

Intervention Type: PROCEDURE

60ml of 0.5% Bupivacaine

Interventions

Peri-articular injection of marcaine/epinephrine

60ml of 0.5% Bupivacaine and Epinephrine 1:200,000 Inj

Intervention Type: PROCEDURE

Peri-articular injection of marcaine alone

60ml of 0.5% Bupivacaine

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rush University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Craig J Delle Valle

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Craig J. Della Valle, MD

Role: PRINCIPAL_INVESTIGATOR

Rush University Medical Center, Department of Orthopaedics

Locations

Rush University Medical Center

Chicago, Illinois, United States

Countries

United States

Other Identifiers

CDV-08012802

Identifier Type: -

Identifier Source: org_study_id