Total Knee ArthroplastyPhase 4NCT02047331
Periarticular Injection Versus Fascia Iliaca Block for Total Knee Arthroplasty
A Phase 4 study testing periarticular injection and fascia iliaca block in people with Total Knee Arthroplasty, run by Baskent University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- periarticular injection and fascia iliaca block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Feb 2013to Aug 2013
- Phase
- Phase 4
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing knee arthroplasty
- > 18 years of age
Who cannot join
- obesity
- heart failure
- kidney failure
- liver failure
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Baskent University School of Medicine Adana Teaching and reserach Hospital
Adana, 01250
About this study
Official title: 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.
Read the 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.
- Conditions
- Total Knee Arthroplasty
- Being tested
- periarticular injection, fascia iliaca block
- Keywords
- periarticular drug injection, fascia iliaca block, knee arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
periarticular injectionProcedure or surgery
patients were performed bupivacaine solution to the periarticular soft tissues during surgery by the surgeon.
fascia iliaca blockProcedure or surgery
patients were performed fascia iliaca block with bupivacaine solution before surgery.
| Study group | Role | What they receive |
|---|---|---|
| group PI | Active comparator | group PI were performed periarticular drug injection during surgery. Receives: Procedure: periarticular injection |
| group FI | Active comparator | group FI were performed fascia iliaca block before surgery Receives: Procedure: fascia iliaca block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain scores of periarticular injection and fascia block for total knee arthroplasty
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.
Measured: postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2014 (estimated)
- Study startFeb 2013
- Primary completionJul 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CAGLA BALI,MD, Baskent University
- Investigators
- Anis Aribogan, Prof.,MD, Study director, Baskent University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02047331
- Sponsor's protocol ID
- KA12/269
- Status last verified
- Jan 2014
- First submitted
- 23 Jan 2014
- Last updated
- 28 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Periarticular Injection Versus Fascia Iliaca Compartment Block for Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT02047331
- Acronym / sponsor ID
- KA12/269
- Conditions
- Total Knee Arthroplasty
- Keywords
- periarticular drug injection, fascia iliaca block, knee arthroplasty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 28 Jan 2014 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group PI | Active comparator | Procedure: periarticular injectiongroup PI were performed periarticular drug injection during surgery. |
| group FI | Active comparator | Procedure: fascia iliaca blockgroup FI were performed fascia iliaca block before surgery |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients undergoing knee arthroplasty
- > 18 years of age
Key exclusion criteria (4 listed)
- obesity
- heart failure
- kidney failure
- liver failure
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 |
|---|---|---|
| periarticular injectionpatients were performed bupivacaine solution to the periarticular soft tissues during surgery by the surgeon. | Procedure or surgery | group PI |
| fascia iliaca blockpatients were performed fascia iliaca block with bupivacaine solution before surgery. | Procedure or surgery | group FI |
Primary outcome
Postoperative pain scores of periarticular injection and fascia block for total knee arthroplasty
Time frame: postoperative 24 hours
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2014.
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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.
Anis Aribogan, Prof.,MD study director
Baskent University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing periarticular injection and fascia iliaca block in people with Total Knee Arthroplasty, run by Baskent University at 1 site in Turkey (Türkiye).
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 28 Jan 2014. 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 Turkey (Türkiye). 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Postoperative pain scores of periarticular injection and fascia block for total knee arthroplasty (time frame: postoperative 24 hours). 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 28 Jan 2014.