OsteoarthritisNCT02513082
Effectiveness of Pain Relief Between Adductor Canal Block and Femoral Nerve Block in Total Knee Arthroplasty
A study testing Sono guided nerve block in people with Osteoarthritis, run by The Catholic University of Korea.
Trial summary
This study aims to compare the effectiveness of adductor canal block and femoral nerve block in total knee arthroplasty in general anesthesia. Two block techniques were proved safe and effective in pain control after total knee arthroplasty. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Sono guided nerve block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to Aug 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients for total knee arthroplasty having medicare insurance
Who cannot join
- Alcohol, drug abuser Narcotics addiction
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effectiveness of Pain Relief Between Adductor Canal Block and Femoral Nerve Block in Total Knee Arthroplasty in General Anesthesia
This study aims to compare the effectiveness of adductor canal block and femoral nerve block in total knee arthroplasty in general anesthesia. Two block techniques were proved safe and effective in pain control after total knee arthroplasty. But some authors insist that quadriceps muscle power was decreased by femoral nerve block. The study design is a double-blind randomized controlled trial. Fifty patients planed to undergo simultaneously bilateral total knee arthroplasty are randomised to receive ultrasound-guided femoral nerve block on one leg and adductor canal block on the other, in addition to combined general anaesthesia. The primary outcome was comparative postoperative pain in either extremity at four, eight, 12, 24, 72 hours and 7days postoperatively. Secondary comparative outcomes included motor strength by cybex test.
Read the detailed description
Total knee arthroplasty(TKA) is very popular in nowadays. But almost patients complained of postoperative pain and it affect the delay of early mobilization which prevent knee stiffness, lessens hospital stay and improves overall patient satisfaction and outcome of TKA. Intravenous patient-controlled analgesia (PCA) or epidural analgesia is a conventional postoperative analgesia. Recently other block techniques like a adductor canal block and femoral nerve block were known for good methods of pain relief after TKA. However, femoral nerve block reduces quadriceps muscle strength thereby potentially compromising postoperative mobilization. Therefore, it is necessary to evaluate the effectiveness of pain treatment and the preservation of muscle function after the procedure of adductor canal block and femoral nerve block.
The present study aimed to determine and compare the efficacy of adductor canal block and femoral nerve block combined with general anesthesia on (1) postoperative pain control, (2) early patient ambulation and functional recovery and (3) change of muscle power after total knee arthroplasty.
- Conditions
- Osteoarthritis
- Being tested
- Sono guided nerve block
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sono guided nerve blockProcedure or surgery
Also called femoral nerve block, adductor canal block
Sono guided nerve block is effectively and safely performed for pain relief after total knee arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| Femoral nerve block | Experimental | Femoral nerve block will be performed just one time after total knee arthroplasty in general anesthesia state Receives: Procedure: Sono guided nerve block |
| Adductor canal block | Active comparator | Adductor canal block will be performed just one time after total knee arthroplasty in general anesthesia state Receives: Procedure: Sono guided nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Visual pain scale
Measured: Changes from the baseline visual pain scale to 1 week after surgery
Secondary outcomes (1)
Changes in Quadriceps muscle power and strength by cybex muscle testing
Measured: 1 week postoperatively compared to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2015 (estimated)
- Study startAug 2015
- Primary completionAug 2016 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yong In, The Catholic University of Korea
- Investigators
- Yong In, MD, PhD, Study chair, the Catholic Univerisity of Korea Seoul St Mary's hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02513082
- Sponsor's protocol ID
- Nerve block
- Status last verified
- Nov 2015
- First submitted
- 28 Jul 2015
- Last updated
- 5 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Koh HJ, Koh IJ, Kim MS, Choi KY, Jo HU, In Y. Does Patient Perception Differ Following Adductor Canal Block and Femoral Nerve Block in Total Knee Arthroplasty? A Simultaneous Bilateral Randomized Study. J Arthroplasty. 2017 Jun;32(6):1856-1861. doi: 10.1016/j.arth.2017.01.025. Epub 2017 Jan 26.
PubMed 28215966
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Pain Relief Between Adductor Canal Block and Femoral Nerve Block in Total Knee Arthroplasty in General Anesthesia
- ClinicalTrials.gov ID
- NCT02513082
- Acronym / sponsor ID
- Nerve block
- Conditions
- Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 31 Jul 2015 (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 aims to compare the effectiveness of adductor canal block and femoral nerve block in total knee arthroplasty in general anesthesia. Two block techniques were proved safe and effective in pain control after total knee arthroplasty. But some authors insist that quadriceps muscle power was decreased by femoral nerve block. The study design is a double-blind randomized controlled trial. Fifty patients planed to undergo simultaneously bilateral total knee arthroplasty are randomised to receive ultrasound-guided femoral nerve block on one leg and adductor canal block on the other, in addition to combined general anaesthesia. The primary outcome was comparative postoperative pain in either extremity at four, eight, 12, 24, 72 hours and 7days postoperatively. Secondary comparative outcomes included motor strength by cybex test.
Detailed description
Total knee arthroplasty(TKA) is very popular in nowadays. But almost patients complained of postoperative pain and it affect the delay of early mobilization which prevent knee stiffness, lessens hospital stay and improves overall patient satisfaction and outcome of TKA. Intravenous patient-controlled analgesia (PCA) or epidural analgesia is a conventional postoperative analgesia. Recently other block techniques like a adductor canal block and femoral nerve block were known for good methods of pain relief after TKA. However, femoral nerve block reduces quadriceps muscle strength thereby potentially compromising postoperative mobilization. Therefore, it is necessary to evaluate the effectiveness of pain treatment and the preservation of muscle function after the procedure of adductor canal block and femoral nerve block.
The present study aimed to determine and compare the efficacy of adductor canal block and femoral nerve block combined with general anesthesia on (1) postoperative pain control, (2) early patient ambulation and functional recovery and (3) change of muscle power after total knee arthroplasty.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Femoral nerve block | Experimental | Procedure: Sono guided nerve blockFemoral nerve block will be performed just one time after total knee arthroplasty in general anesthesia state |
| Adductor canal block | Active comparator | Procedure: Sono guided nerve blockAdductor canal block will be performed just one time after total knee arthroplasty in general anesthesia state |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients for total knee arthroplasty having medicare insurance
Key exclusion criteria (1 listed)
- Alcohol, drug abuser Narcotics addiction
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 |
|---|---|---|
| Sono guided nerve blockAlso: femoral nerve block, adductor canal blockSono guided nerve block is effectively and safely performed for pain relief after total knee arthroplasty | Procedure or surgery | Adductor canal block, Femoral nerve block |
Primary outcome
Changes in Visual pain scale
Time frame: Changes from the baseline visual pain scale to 1 week after surgery
1 secondary outcome
Changes in Quadriceps muscle power and strength by cybex muscle testing
Time frame: 1 week postoperatively compared to baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2015.
- Derived from this study: PubMed 28215966Koh HJ, Koh IJ, Kim MS, Choi KY, Jo HU, In Y. Does Patient Perception Differ Following Adductor Canal Block and Femoral Nerve Block in Total Knee Arthroplasty? A Simultaneous Bilateral Randomized Study. J Arthroplasty. 2017 Jun;32(6):1856-1861. doi: 10.1016/j.arth.2017.01.025. Epub 2017 Jan 26.
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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.
Yong In, MD, PhD study chair
the Catholic Univerisity of Korea Seoul St Mary's hospital
Questions about this trial
What is this clinical trial studying?
A study testing Sono guided nerve block in people with Osteoarthritis, run by The Catholic University of Korea.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 5 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yong In, MD, PhD (8290445228, iy1000@catholic.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Visual pain scale (time frame: Changes from the baseline visual pain scale to 1 week after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02513082, which also lists 1 linked publication.
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 5 Nov 2015.