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

This study has been terminated.
(Prohibitively expensive and efficacy of tranexamic acid rendered topic clinically less relevant.)
Sponsor:
Information provided by (Responsible Party):
Craig J Delle Valle, Rush University Medical Center
ClinicalTrials.gov Identifier:
NCT00737139
First received: August 15, 2008
Last updated: August 29, 2012
Last verified: August 2012
  Purpose

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 Intervention
Osteoarthritis
Procedure: Peri-articular injection of marcaine/epinephrine
Procedure: Peri-articular injection of marcaine alone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Rush University Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 33
Study Start Date: September 2008
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   19 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00737139

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

No publications provided

Responsible Party: Craig J Delle Valle, MD, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT00737139     History of Changes
Other Study ID Numbers: CDV-08012802
Study First Received: August 15, 2008
Last Updated: August 29, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Rush University Medical Center:
Hip
Knee
Arthroplasty
Epinephrine
Hemostasis

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Bupivacaine
Epinephrine
Epinephryl borate
Racepinephrine
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-Agonists
Adrenergic beta-Agonists
Anesthetics
Anesthetics, Local
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Molecular Mechanisms of Pharmacological Action
Mydriatics
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Sensory System Agents
Sympathomimetics

ClinicalTrials.gov processed this record on October 23, 2014