Knee ArthroplastyNCT01763814
Three Different Approaches for Ultrasound Guided Femoral Nerve Block for Patients Undergoing Total Knee Arthroplasty
A study testing Femoral nerve block, Femoral nerve block non stimulating catheter and Femoral nerve block stimulating catheter in people with Knee Arthroplasty, run by Chicago Anesthesia Pain Specialists at 1 site in United States.
Trial summary
Patients scheduled to have a surgery for Total Knee Arthroplasty will be assigned to one of three groups, each group will use a different approach using the ultrasound to guide the femoral nerve block as part of their treatment for controlling pain post-operatively. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Knee Arthroplasty
- What is being tested?
- Femoral nerve block, Femoral nerve block non stimulating catheter and Femoral nerve block stimulating catheter
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Apr 2019
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18- 90 years old
- Scheduled for total knee arthroplasty
Who cannot join
- Redo surgery on the same knee
- BMI ≥45
- Radicular pain in the same leg
- Allergy to local anesthetics
- Opioid habituation
- Pregnancy
Show all 9Show fewer
- Contraindication to regional block
- Inability to communicate with hospital staff or investigators.
- Neuropathy of any etiology in the surgical extremity.
Trial locations and contacts
1 site in 1 country.
United States1 site
Chicago Anesthesia Pain Specialists
Chicago, Illinois, 60657
About this study
Official title: A Randomized, Single Blind Study of the Efficacy and Safety of Three Different Approaches for Ultrasound Guided Femoral Nerve Block for Patients Undergoing Total Knee Arthroplasty
Patients scheduled to have a surgery for Total Knee Arthroplasty will be assigned to one of three groups, each group will use a different approach using the ultrasound to guide the femoral nerve block as part of their treatment for controlling pain post-operatively.
Read the detailed description
This will be a prospective, single-blinded, randomized study. The patients will be randomly assigned to one of three groups:
Group I - single shot femoral nerve block Group II - continuous femoral nerve block - non stimulating catheter Group III - continuous femoral nerve block - stimulating catheter
- Conditions
- Knee Arthroplasty
- Being tested
- Femoral nerve block, Femoral nerve block non stimulating catheter, Femoral nerve block stimulating catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Femoral nerve blockProcedure or surgery
A visible or palpable cephalad movement of the patella will confirm needle placement.
Femoral nerve block non stimulating catheterProcedure or surgery
A visible or palpable cephalad movement of the patella will confirm needle placement. The catheter will be placed with the nerve stimulator powered off.
Femoral nerve block stimulating catheterProcedure or surgery
A visible or palpable cephalad movement of the patella will confirm needle placement. The catheter will be placed with the nerve stimulator powered on.
| Study group | Role | What they receive |
|---|---|---|
| Single shot femoral nerve block | Active comparator | A ultrasound probe will be used to identify the nerve, and correct needle placement. Receives: Procedure: Femoral nerve block |
| Femoral nerve block non stimulating catheter | Active comparator | A ultrasound probe will be used to identify the nerve, and correct needle placement. The catheter will be placed with the nerve stimulator powered off. Receives: Procedure: Femoral nerve block; Procedure: Femoral nerve block non stimulating catheter |
| Femoral nerve block stimulating catheter | Active comparator | A ultrasound probe will be used to identify the nerve, and correct needle placement. The catheter will be placed with the nerve stimulator powered on. Receives: Procedure: Femoral nerve block; Procedure: Femoral nerve block stimulating catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Numeric Rating Pain Score
At the conclusion of the surgery time 0, at 15, 30, and 45 minutes, at 1, 12, 24, 48 hours, and day 3, 7, 14, and 30 after the surgery.
Measured: Postoperative
Secondary outcomes (2)
Change in the ability to move the knee
At the conclusion of the surgery time 0, at 15, 30, and 45 minutes, at 1, 12, 24, 48 hours, and day 3, 7, 14, and 30 after the surgery.
Measured: Postoperative
Change in Supplemental pain medications
At the conclusion of the surgery time 0, at 15, 30, and 45 minutes, at 1, 12, 24, 48 hours, and day 3, 7, 14, and 30 after the surgery.
Measured: Postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2013 (estimated)
- Study startDec 2011
- Primary completionFeb 2018
- Study completionApr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chicago Anesthesia Pain Specialists
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antony Tharian, Chicago Anesthesia Pain Specialists
- Investigators
- Antony Tharian, M.D., Principal investigator, Chicago Anesthesia Pain Specialists
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01763814
- Sponsor's protocol ID
- Advocate-IRB-5235
- Status last verified
- Jun 2019
- First submitted
- 2 Jan 2013
- Last updated
- 7 Jun 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single Blind Study of the Efficacy and Safety of Three Different Approaches for Ultrasound Guided Femoral Nerve Block for Patients Undergoing Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT01763814
- Acronym / sponsor ID
- Advocate-IRB-5235
- Conditions
- Knee Arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Chicago Anesthesia Pain SpecialistsUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Feb 2018 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 9 Jan 2013 (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.
Patients scheduled to have a surgery for Total Knee Arthroplasty will be assigned to one of three groups, each group will use a different approach using the ultrasound to guide the femoral nerve block as part of their treatment for controlling pain post-operatively.
Detailed description
This will be a prospective, single-blinded, randomized study. The patients will be randomly assigned to one of three groups:
Group I - single shot femoral nerve block Group II - continuous femoral nerve block - non stimulating catheter Group III - continuous femoral nerve block - stimulating catheter
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Single shot femoral nerve block | Active comparator | Procedure: Femoral nerve blockA ultrasound probe will be used to identify the nerve, and correct needle placement. |
| Femoral nerve block non stimulating catheter | Active comparator | Procedure: Femoral nerve block, Procedure: Femoral nerve block non stimulating catheterA ultrasound probe will be used to identify the nerve, and correct needle placement. The catheter will be placed with the nerve stimulator powered off. |
| Femoral nerve block stimulating catheter | Active comparator | Procedure: Femoral nerve block, Procedure: Femoral nerve block stimulating catheterA ultrasound probe will be used to identify the nerve, and correct needle placement. The catheter will be placed with the nerve stimulator powered on. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18- 90 years old
- Scheduled for total knee arthroplasty
Key exclusion criteria (9 listed)
- Redo surgery on the same knee
- BMI ≥45
- Radicular pain in the same leg
- Allergy to local anesthetics
- Opioid habituation
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 |
|---|---|---|
| Femoral nerve blockA visible or palpable cephalad movement of the patella will confirm needle placement. | Procedure or surgery | Femoral nerve block non stimulating catheter, Femoral nerve block stimulating catheter, Single shot femoral nerve block |
| Femoral nerve block non stimulating catheterA visible or palpable cephalad movement of the patella will confirm needle placement. The catheter will be placed with the nerve stimulator powered off. | Procedure or surgery | Femoral nerve block non stimulating catheter |
| Femoral nerve block stimulating catheterA visible or palpable cephalad movement of the patella will confirm needle placement. The catheter will be placed with the nerve stimulator powered on. | Procedure or surgery | Femoral nerve block stimulating catheter |
Primary outcome
Change in the Numeric Rating Pain Score
Time frame: Postoperative
At the conclusion of the surgery time 0, at 15, 30, and 45 minutes, at 1, 12, 24, 48 hours, and day 3, 7, 14, and 30 after the surgery.
2 secondary outcomes
Change in the ability to move the knee
Time frame: Postoperative
Change in Supplemental pain medications
Time frame: Postoperative
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 7 Jun 2019.
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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.
Antony Tharian, M.D. principal investigator
Chicago Anesthesia Pain Specialists
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Femoral nerve block, Femoral nerve block non stimulating catheter and Femoral nerve block stimulating catheter in people with Knee Arthroplasty, run by Chicago Anesthesia Pain Specialists 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 2 inclusion and 9 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 7 Jun 2019. 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 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?
Change in the Numeric Rating Pain Score (time frame: Postoperative). 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 7 Jun 2019.