- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02047331
Periarticular Injection Versus Fascia Iliaca Block for Total Knee Arthroplasty
January 27, 2014 updated by: CAGLA BALI,MD, Baskent University
Multimodal Periarticular Injection Versus Fascia Iliaca Compartment Block for Total Knee Arthroplasty
In this study, the aim is to compare the efficacy of Periarticular multimodal drug injection(group PI) and Fascia Iliaca Compartment Block ( group FI)for total knee arthroplasty.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Total knee arthroplasty is very painful surgical intervention.Patients were assigned to 2 groups to receive either periarticular multimodal drug injection or fascia iliaca compartment block for postoperative pain.
Study Type
Interventional
Enrollment (Actual)
66
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Adana, Turkey, 01250
- Baskent University School of Medicine Adana Teaching and reserach Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- patients undergoing knee arthroplasty
- > 18 years of age
Exclusion Criteria:
- obesity
- heart failure
- kidney failure
- liver failure
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: group PI
group PI were performed periarticular drug injection during surgery.
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patients were performed bupivacaine solution to the periarticular soft tissues during surgery by the surgeon.
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Active Comparator: group FI
group FI were performed fascia iliaca block before surgery
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patients were performed fascia iliaca block with bupivacaine solution before surgery.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative pain scores of periarticular injection and fascia block for total knee arthroplasty
Time Frame: postoperative 24 hours
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Patients were assigned in two groups to perform either periarticular injection (group PI) and fascia block ( group FB).
They were accessed by visual analog scale.
The aim was to compare the efficacy and side effects of periarticular injection and fascia block.
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postoperative 24 hours
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Anis Aribogan, Prof.,MD, Başkent University School of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2013
Primary Completion (Actual)
July 1, 2013
Study Completion (Actual)
August 1, 2013
Study Registration Dates
First Submitted
January 23, 2014
First Submitted That Met QC Criteria
January 27, 2014
First Posted (Estimate)
January 28, 2014
Study Record Updates
Last Update Posted (Estimate)
January 28, 2014
Last Update Submitted That Met QC Criteria
January 27, 2014
Last Verified
January 1, 2014
More Information
Terms related to this study
Other Study ID Numbers
- KA12/269
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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