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

NCT00737139 | Terminated

• 1 other identifier: CDV-08012802
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis

Keywords

Hip; Knee; Arthroplasty; Epinephrine; Hemostasis

Outcome Measures

Primary Outcomes (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.

  Daily for 6 weeks postoperatively

Secondary Outcomes (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.

  Daily for 6 weeks post-operatively

Study Arms (2)

1

ACTIVE COMPARATOR

Intra-articular Injection of Marcaine/Epinephrine

Procedure: Peri-articular injection of marcaine/epinephrine

2

ACTIVE COMPARATOR

Intra-articular Injection of Marcaine alone

Procedure: Peri-articular injection of marcaine alone

Interventions

Peri-articular injection of marcaine/epinephrine PROCEDURE

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

1

Peri-articular injection of marcaine alone PROCEDURE

60ml of 0.5% Bupivacaine

2

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Epinephrine

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Craig J. Della Valle, MD

  Rush University Medical Center, Department of Orthopaedics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 15, 2008
• First Posted: August 18, 2008
• Study Start: September 1, 2008
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: August 31, 2012

Record last verified: 2012-08

Locations

US (1)