Quadriceps Function Monitored With ElectromyographyNCT04778774
Compare the Quadriceps Function of Adductor Canal Block Versus Femoral Nerve Block With Electromyography Following Total Knee Arthroplasty
A study testing Nerve block in people with Quadriceps Function Monitored With Electromyography, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
Adductor canal block and femoral nerve block are the most commonly used nerve blocks for pain control after total knee arthroplasty. The block area for adductor canal is a sensory branch near the knee area, which can potentially reduce the effect of motor blockage of quadriceps muscle. Read more about this study
- Who is it for?
- Ages 50 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Quadriceps Function Monitored With Electromyography
- What is being tested?
- Nerve block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 24 Feb 2021to 29 Nov 2021
- 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 50 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age at least 50 years old, not exceed 100 years old
- Diagnosed Primary Knee Osteoarthritis
- Accepted Total Knee Arthroplasty
Who cannot join
- Diagnosed Osteonecrosis
- Diagnosed inflammatory Arthritis、Rheumatoid Arthritis
- Accepted Revision Total Knee Arthroplasty
- Quadriceps muscle rupture, suture or repair history
- Neurological or orthopedic disorders that could affect quadriceps muscle power
- Allergy to amide anesthetics
- Patients who cannot obey or follow directions
Trial locations and contacts
1 site in 1 country.
About this study
Adductor canal block and femoral nerve block are the most commonly used nerve blocks for pain control after total knee arthroplasty. The block area for adductor canal is a sensory branch near the knee area, which can potentially reduce the effect of motor blockage of quadriceps muscle. We try to proof adductor canal block can reduce the pain level after surgery effectively and preserve the muscle power of quadriceps muscle. Therefore, the rehabilitation course can be reduced and further lowering the risks of falling and complications.
- Being tested
- Nerve block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nerve blockProcedure or surgery
Two different nerve block types, Adductor canal block group and Femoral nerve block group
| Study group | Role | What they receive |
|---|---|---|
| Adductor canal block group | Experimental | Adductor canal block group Receives: Procedure: Nerve block |
| Femoral nerve block group | Experimental | Femoral nerve block group Receives: Procedure: Nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quadriceps muscle Electromyography voltage level change before and after nerve block
surface electromyography level
Measured: compare difference of Quadriceps muscle Electromyography voltage level 12 weeks after surgery,data were measured post operation day 1, day 2, day 5, 2 weeks, 6 weeks and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start24 Feb 2021
- Primary completion18 Oct 2021
- Study completion29 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quadriceps Function Monitored With ElectromyographyStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial HospitalThe 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hsuan-Ti Huang, M.D, Study director, Kaohsiung Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04778774
- Sponsor's protocol ID
- KMUHIRB-F(I)-20200031
- Status last verified
- Feb 2021
- First submitted
- 25 Feb 2021
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compare the Quadriceps Function of Adductor Canal Block Versus Femoral Nerve Block With Electromyography Following Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT04778774
- Acronym / sponsor ID
- KMUHIRB-F(I)-20200031
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 24 Feb 2021 (actual)
- Primary completion
- 18 Oct 2021 (actual)
- Study completion
- 29 Nov 2021 (actual)
- First posted
- 3 Mar 2021 (actual)
- 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.
Adductor canal block and femoral nerve block are the most commonly used nerve blocks for pain control after total knee arthroplasty. The block area for adductor canal is a sensory branch near the knee area, which can potentially reduce the effect of motor blockage of quadriceps muscle. We try to proof adductor canal block can reduce the pain level after surgery effectively and preserve the muscle power of quadriceps muscle. Therefore, the rehabilitation course can be reduced and further lowering the risks of falling and complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adductor canal block group | Experimental | Procedure: Nerve blockAdductor canal block group |
| Femoral nerve block group | Experimental | Procedure: Nerve blockFemoral nerve block group |
Who may qualify
- Ages
- 50 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age at least 50 years old, not exceed 100 years old
- Diagnosed Primary Knee Osteoarthritis
- Accepted Total Knee Arthroplasty
Key exclusion criteria (7 listed)
- Diagnosed Osteonecrosis
- Diagnosed inflammatory Arthritis、Rheumatoid Arthritis
- Accepted Revision Total Knee Arthroplasty
- Quadriceps muscle rupture, suture or repair history
- Neurological or orthopedic disorders that could affect quadriceps muscle power
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 |
|---|---|---|
| Nerve blockTwo different nerve block types, Adductor canal block group and Femoral nerve block group | Procedure or surgery | Adductor canal block group, Femoral nerve block group |
Primary outcome
Quadriceps muscle Electromyography voltage level change before and after nerve block
Time frame: compare difference of Quadriceps muscle Electromyography voltage level 12 weeks after surgery,data were measured post operation day 1, day 2, day 5, 2 weeks, 6 weeks and 12 weeks
surface electromyography level
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 2 Mar 2022.
- Individual participant dataSharing planned: No
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.
Hsuan-Ti Huang, M.D study director
Kaohsiung Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nerve block in people with Quadriceps Function Monitored With Electromyography, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
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 3 inclusion and 7 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 2 Mar 2022. 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 Taiwan. 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?
Quadriceps muscle Electromyography voltage level change before and after nerve block (time frame: compare difference of Quadriceps muscle Electromyography voltage level 12 weeks after surgery,data were measured post operation day 1, day 2, day 5, 2 weeks, 6 weeks and 12 weeks). 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 2 Mar 2022.