Degenerative ArthritisNCT04206150
The Appropriate Level of Continuous Adductor Canal Block in Patients Undergoing Total Knee Arthroplasty (TKA)
A study testing the three different sites of continous adductor canal block: the adductor canal catheter is inserted at femoral triangle apex, the three different sites of continous adductor canal block: the adductor canal catheter is inserted femur length/15*2 cm above the location and the three different sites of continous adductor canal block: the adductor canal catheter is inserted femur length/15 cm below the location in people with Degenerative Arthritis, run by Yonsei University at 1 site in South Korea.
Trial summary
Adductor canal catheters are being used to provide continuous postoperative analgesia after total knee arthroplasty surgery (TKA). There is much debate about where is the best position of continuous adductor canal block in patients undergoing TKA. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Degenerative Arthritis
- What is being tested?
- the three different sites of continous adductor canal block: the adductor canal catheter is inserted at femoral triangle apex, the three different sites of continous adductor canal block: the adductor canal catheter is inserted femur length/15*2 cm above the location and the three different sites of continous adductor canal block: the adductor canal catheter is inserted femur length/15 cm below the location
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Apr 2020to 17 Jul 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Patients undergoing total knee arthroplasty
Who cannot join
- 1. Patients who have infection or had surgery on the thigh
- 2. The subject is a foreigner or illiterate
- 3. Patients who have cognitive dysfunction
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine
Seoul, 03722
About this study
Adductor canal catheters are being used to provide continuous postoperative analgesia after total knee arthroplasty surgery (TKA). There is much debate about where is the best position of continuous adductor canal block in patients undergoing TKA. Therefore, the investigators aim to compare the postoperative pain at three different level of continuous adductor canal block. Ninety six patients scheduled for total knee arthroplasty will be randomly divided into the three groups. In group 1, the adductor canal catheter is inserted at femoral triangle apex (the proximal end of the adductor canal). In group 2, the adductor canal catheter is inserted femur length/15*2 cm above the location where the nerve block performed in group 1. In group 3, the adductor canal catheter is inserted femur length/15cm below the location where the nerve block performed in group 1.
- Conditions
- Degenerative Arthritis
- Being tested
- the three different sites of continous adductor canal block: the adductor canal catheter is inserted at femoral triangle apex, the three different sites of continous adductor canal block: the adductor canal catheter is inserted femur length/15*2 cm above the location, the three different sites of continous adductor canal block: the adductor canal catheter is inserted femur length/15 cm below the location
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the three different sites of continous adductor canal block: the adductor canal catheter is inserted at femoral triangle apexProcedure or surgery
In group 1, the adductor canal catheter is inserted at femoral triangle apex (the proximal end of the adductor canal).
the three different sites of continous adductor canal block: the adductor canal catheter is inserted femur length/15*2 cm above the locationProcedure or surgery
In group 2, the adductor canal catheter is inserted femur length/15*2 cm above the location where the nerve block performed in group 1.
the three different sites of continous adductor canal block: the adductor canal catheter is inserted femur length/15 cm below the locationProcedure or surgery
In group 3, the adductor canal catheter is inserted femur length/15 cm below the location where the nerve block performed in group 1.
| Study group | Role | What they receive |
|---|---|---|
| Group 1(femoral triangle apex) | Active comparator | the adductor canal catheter is inserted at femoral triangle apex (the proximal end of the adductor canal) Receives: Procedure: the three different sites of continous adductor canal block: the adductor canal catheter is inserted at femoral triangle apex |
| Group 2(femur length/15*2 cm above) | Active comparator | the adductor canal catheter is inserted femur length/15*2 cm above the location where the nerve block performed in group 1 Receives: Procedure: the three different sites of continous adductor canal block: the adductor canal catheter is inserted femur length/15*2 cm above the location |
| Group 3(femur length/15 cm below) | Active comparator | the adductor canal catheter is inserted femur length/15cm below the location where the nerve block performed in group 1. Receives: Procedure: the three different sites of continous adductor canal block: the adductor canal catheter is inserted femur length/15 cm below the location |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain : Visual Analogue Scale (VAS) for pain
The visual analog scale(VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" (0) and "worst pain." (10). The ends are defined as the extreme limits of the parameter to be measured(symptom,pain,health) orientated from the left(0, worst) to the right(10, best).
Measured: Baseline (Before surgery)
Pain : Visual Analogue Scale (VAS) for pain
The visual analog scale(VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" (0) and "worst pain." (10). The ends are defined as the extreme limits of the parameter to be measured(symptom,pain,health) orientated from the left(0, worst) to the right(10, best).
Measured: postoperative day 1
Pain : Visual Analogue Scale (VAS) for pain
The visual analog scale(VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" (0) and "worst pain." (10). The ends are defined as the extreme limits of the parameter to be measured(symptom,pain,health) orientated from the left(0, worst) to the right(10, best).
Measured: postoperative day 2
Secondary outcomes (3)
muscle strength
Quadriceps strength of both legs was assessed by placing the dynamometer on the anterior of the ankle, between the malleoli.
Measured: Baseline (Before surgery)
muscle strength
Quadriceps strength of both legs was assessed by placing the dynamometer on the anterior of the ankle, between the malleoli.
Measured: postoperative day 1
muscle strength
Quadriceps strength of both legs was assessed by placing the dynamometer on the anterior of the ankle, between the malleoli.
Measured: postoperative day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2019
- Study start2 Apr 2020
- Primary completion16 Jul 2021
- Study completion17 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Degenerative ArthritisStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Model description
- Ninety six patients scheduled for total knee arthroplasty will be randomly divided into the three groups. In group 1, the adductor canal catheter is inserted at femoral triangle apex (the proximal end of the adductor canal). In group 2, the adductor canal catheter is inserted femur length/15\*2 cm above the location where the nerve block performed in group 1. In group 3, the adductor canal catheter is inserted femur length/15\*2 cm below the location where the nerve block performed in group 1.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04206150
- Sponsor's protocol ID
- 4-2019-1038
- Status last verified
- Oct 2021
- First submitted
- 17 Dec 2019
- Last updated
- 15 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chuan A, Lansdown A, Brick KL, Bourgeois AJG, Pencheva LB, Hue B, Goddard S, Lennon MJ, Walters A, Auyong D; Continuous Catheters in Adductor Canal versus Femoral Triangle (The CAFE study) investigators. Adductor canal versus femoral triangle anatomical locations for continuous catheter analgesia after total knee arthroplasty: a multicentre randomised controlled study. Br J Anaesth. 2019 Sep;123(3):360-367. doi: 10.1016/j.bja.2019.03.021. Epub 2019 May 2.
PubMed 31056239Sztain JF, Khatibi B, Monahan AM, Said ET, Abramson WB, Gabriel RA, Finneran JJ 4th, Bellars RH, Nguyen PL, Ball ST, Gonzales FB, Ahmed SS, Donohue MC, Padwal JA, Ilfeld BM. Proximal Versus Distal Continuous Adductor Canal Blocks: Does Varying Perineural Catheter Location Influence Analgesia? A Randomized, Subject-Masked, Controlled Clinical Trial. Anesth Analg. 2018 Jul;127(1):240-246. doi: 10.1213/ANE.0000000000003422.
PubMed 29750695Lee B, Park SJ, Park KK, Kim HJ, Lee YS, Choi YS. Optimal location for continuous catheter analgesia among the femoral triangle, proximal, or distal adductor canal after total knee arthroplasty: a randomized double-blind controlled trial. Reg Anesth Pain Med. 2022 Jun;47(6):353-358. doi: 10.1136/rapm-2021-103284. Epub 2022 Feb 16.
PubMed 35173020
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Appropriate Level of Continuous Adductor Canal Block in Patients Undergoing Total Knee Arthroplasty (TKA)
- ClinicalTrials.gov ID
- NCT04206150
- Acronym / sponsor ID
- 4-2019-1038
- Conditions
- Degenerative Arthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 2 Apr 2020 (actual)
- Primary completion
- 16 Jul 2021 (actual)
- Study completion
- 17 Jul 2021 (actual)
- First posted
- 20 Dec 2019 (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 catheters are being used to provide continuous postoperative analgesia after total knee arthroplasty surgery (TKA). There is much debate about where is the best position of continuous adductor canal block in patients undergoing TKA. Therefore, the investigators aim to compare the postoperative pain at three different level of continuous adductor canal block. Ninety six patients scheduled for total knee arthroplasty will be randomly divided into the three groups. In group 1, the adductor canal catheter is inserted at femoral triangle apex (the proximal end of the adductor canal). In group 2, the adductor canal catheter is inserted femur length/15*2 cm above the location where the nerve block performed in group 1. In group 3, the adductor canal catheter is inserted femur length/15cm below the location where the nerve block performed in group 1.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Ninety six patients scheduled for total knee arthroplasty will be randomly divided into the three groups. In group 1, the adductor canal catheter is inserted at femoral triangle apex (the proximal end of the adductor canal). In group 2, the adductor canal catheter is inserted femur length/15*2 cm above the location where the nerve block performed in group 1. In group 3, the adductor canal catheter is inserted femur length/15*2 cm below the location where the nerve block performed in group 1.
| Arm | Type | Receives |
|---|---|---|
| Group 1(femoral triangle apex) | Active comparator | Procedure: the three different sites of continous adductor canal block: the adductor canal catheter is inserted at femoral triangle apexthe adductor canal catheter is inserted at femoral triangle apex (the proximal end of the adductor canal) |
| Group 2(femur length/15*2 cm above) | Active comparator | Procedure: the three different sites of continous adductor canal block: the adductor canal catheter is inserted femur length/15*2 cm above the locationthe adductor canal catheter is inserted femur length/15*2 cm above the location where the nerve block performed in group 1 |
| Group 3(femur length/15 cm below) | Active comparator | Procedure: the three different sites of continous adductor canal block: the adductor canal catheter is inserted femur length/15 cm below the locationthe adductor canal catheter is inserted femur length/15cm below the location where the nerve block performed in group 1. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Patients undergoing total knee arthroplasty
Key exclusion criteria (3 listed)
- 1. Patients who have infection or had surgery on the thigh
- 2. The subject is a foreigner or illiterate
- 3. Patients who have cognitive dysfunction
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 |
|---|---|---|
| the three different sites of continous adductor canal block: the adductor canal catheter is inserted at femoral triangle apexIn group 1, the adductor canal catheter is inserted at femoral triangle apex (the proximal end of the adductor canal). | Procedure or surgery | Group 1(femoral triangle apex) |
| the three different sites of continous adductor canal block: the adductor canal catheter is inserted femur length/15*2 cm above the locationIn group 2, the adductor canal catheter is inserted femur length/15*2 cm above the location where the nerve block performed in group 1. | Procedure or surgery | Group 2(femur length/15*2 cm above) |
| the three different sites of continous adductor canal block: the adductor canal catheter is inserted femur length/15 cm below the locationIn group 3, the adductor canal catheter is inserted femur length/15 cm below the location where the nerve block performed in group 1. | Procedure or surgery | Group 3(femur length/15 cm below) |
Primary outcome
Pain : Visual Analogue Scale (VAS) for pain
Time frame: Baseline (Before surgery)
The visual analog scale(VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" (0) and "worst pain." (10). The ends are defined as the extreme limits of the parameter to be measured(symptom,pain,health) orientated from the left(0, worst) to the right(10, best).
Pain : Visual Analogue Scale (VAS) for pain
Time frame: postoperative day 1
The visual analog scale(VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" (0) and "worst pain." (10). The ends are defined as the extreme limits of the parameter to be measured(symptom,pain,health) orientated from the left(0, worst) to the right(10, best).
Pain : Visual Analogue Scale (VAS) for pain
Time frame: postoperative day 2
The visual analog scale(VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" (0) and "worst pain." (10). The ends are defined as the extreme limits of the parameter to be measured(symptom,pain,health) orientated from the left(0, worst) to the right(10, best).
3 secondary outcomes
muscle strength
Time frame: Baseline (Before surgery)
muscle strength
Time frame: postoperative day 1
muscle strength
Time frame: postoperative day 2
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 15 Oct 2021.
- Background: PubMed 31056239Chuan A, Lansdown A, Brick KL, Bourgeois AJG, Pencheva LB, Hue B, Goddard S, Lennon MJ, Walters A, Auyong D; Continuous Catheters in Adductor Canal versus Femoral Triangle (The CAFE study) investigators. Adductor canal versus femoral triangle anatomical locations for continuous catheter analgesia after total knee arthroplasty: a multicentre randomised controlled study. Br J Anaesth. 2019 Sep;123(3):360-367. doi: 10.1016/j.bja.2019.03.021. Epub 2019 May 2.
- Background: PubMed 29750695Sztain JF, Khatibi B, Monahan AM, Said ET, Abramson WB, Gabriel RA, Finneran JJ 4th, Bellars RH, Nguyen PL, Ball ST, Gonzales FB, Ahmed SS, Donohue MC, Padwal JA, Ilfeld BM. Proximal Versus Distal Continuous Adductor Canal Blocks: Does Varying Perineural Catheter Location Influence Analgesia? A Randomized, Subject-Masked, Controlled Clinical Trial. Anesth Analg. 2018 Jul;127(1):240-246. doi: 10.1213/ANE.0000000000003422.
- Derived from this study: PubMed 35173020Lee B, Park SJ, Park KK, Kim HJ, Lee YS, Choi YS. Optimal location for continuous catheter analgesia among the femoral triangle, proximal, or distal adductor canal after total knee arthroplasty: a randomized double-blind controlled trial. Reg Anesth Pain Med. 2022 Jun;47(6):353-358. doi: 10.1136/rapm-2021-103284. Epub 2022 Feb 16.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the three different sites of continous adductor canal block: the adductor canal catheter is inserted at femoral triangle apex, the three different sites of continous adductor canal block: the adductor canal catheter is inserted femur length/15*2 cm above the location and the three different sites of continous adductor canal block: the adductor canal catheter is inserted femur length/15 cm below the location in people with Degenerative Arthritis, run by Yonsei University at 1 site in South 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 3 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 15 Oct 2021. 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 South Korea. 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?
Pain : Visual Analogue Scale (VAS) for pain (time frame: Baseline (Before surgery)). The study lists 3 primary outcomes in all. 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 NCT04206150, which also lists 3 linked publications.
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 15 Oct 2021.