OsteoarthritisNCT00737139
Study Comparing Peri-articular Injection of Bupivacaine With and Without Epinephrine
A study testing Peri-articular injection of marcaine/epinephrine and Peri-articular injection of marcaine alone in people with Osteoarthritis, run by Rush University Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 19 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Peri-articular injection of marcaine/epinephrine and Peri-articular injection of marcaine alone
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Apr 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
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
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.
Read the 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
- Being tested
- Peri-articular injection of marcaine/epinephrine, Peri-articular injection of marcaine alone
- Keywords
- Hip, Knee, Arthroplasty, Epinephrine, Hemostasis
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peri-articular injection of marcaine/epinephrineProcedure or surgery
60ml of 0.5% Bupivacaine and Epinephrine 1:200,000 Inj
Peri-articular injection of marcaine aloneProcedure or surgery
60ml of 0.5% Bupivacaine
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Intra-articular Injection of Marcaine/Epinephrine Receives: Procedure: Peri-articular injection of marcaine/epinephrine |
| 2 | Active comparator | Intra-articular Injection of Marcaine alone Receives: Procedure: Peri-articular injection of marcaine alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Daily for 6 weeks post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2008 (estimated)
- Study startSep 2008
- Primary completionApr 2012
- Study completionApr 2012
Why it stopped: Prohibitively expensive and efficacy of tranexamic acid rendered topic clinically less relevant.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Craig J Delle Valle, Rush University Medical Center
- Investigators
- Craig J. Della Valle, MD, Principal investigator, Rush University Medical Center, Department of Orthopaedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00737139
- Sponsor's protocol ID
- CDV-08012802
- Status last verified
- Aug 2012
- First submitted
- 15 Aug 2008
- Last updated
- 31 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00737139
- Acronym / sponsor ID
- CDV-08012802
- Conditions
- Osteoarthritis
- Keywords
- Hip, Knee, Arthroplasty, Epinephrine, Hemostasis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Prohibitively expensive and efficacy of tranexamic acid rendered topic clinically less relevant.
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 18 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Peri-articular injection of marcaine/epinephrineIntra-articular Injection of Marcaine/Epinephrine |
| 2 | Active comparator | Procedure: Peri-articular injection of marcaine aloneIntra-articular Injection of Marcaine alone |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peri-articular injection of marcaine/epinephrine60ml of 0.5% Bupivacaine and Epinephrine 1:200,000 Inj | Procedure or surgery | 1 |
| Peri-articular injection of marcaine alone60ml of 0.5% Bupivacaine | Procedure or surgery | 2 |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study was stopped early (reason given: Prohibitively expensive and efficacy of tranexamic acid rendered topic clinically less relevant.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Craig J. Della Valle, MD principal investigator
Rush University Medical Center, Department of Orthopaedics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peri-articular injection of marcaine/epinephrine and Peri-articular injection of marcaine alone in people with Osteoarthritis, run by Rush University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Prohibitively expensive and efficacy of tranexamic acid rendered topic clinically less relevant.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2012.