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

Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00737139
• Other study ID #: CDV-08012802
• Status: Terminated
• Phase: N/A
• First received: August 15, 2008
• Last updated: August 29, 2012
• Start date: September 2008
• Est. completion date: April 2012

Study information

• Verified date: August 2012
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 33
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Procedure:
• Peri-articular injection of marcaine/epinephrine
60ml of 0.5% Bupivacaine and Epinephrine 1:200,000 Inj
• Peri-articular injection of marcaine alone
60ml of 0.5% Bupivacaine

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Rush University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Daily for 6 weeks postoperatively	No
Secondary	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.		Daily for 6 weeks post-operatively	No