Pain MeasurementNCT06201195
Anterior Cutaneus Nerve and Distal Adductor Canal Block With USG for Total Knee Replacement Analgesia
A study testing Adductor canal blockade and Distal adductor canala blockade and anterior cutaneus nerve blockade in people with Pain Measurement and Knee Replacement Arthroplasty, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This prospective clinical study was approved by the institutional ethics committee on September 27, 2023, and patient enrollment started in October 2023. the study aimed to evaluate the contribution of anterior femoral cutaneus nerve block to postoperative analgesia in total knee artroplasty. Read more about this study
- Who is it for?
- Ages 40 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain Measurement, Knee Replacement Arthroplasty, Nerve Block
- What is being tested?
- Adductor canal blockade and Distal adductor canala blockade and anterior cutaneus nerve blockade
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2023to 30 Jun 2024
- 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 40 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Total knee artroplasty
- Spinal anesthesia
- ASA 1-3
Who cannot join
- Bupivacaine allergy
- Coagulopathy
- Infection on injection site
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Contribution of Anterior Femoral Cutaneous Nerve Block to Postoperative Analgesia for Total Knee Replacement
This prospective clinical study was approved by the institutional ethics committee on September 27, 2023, and patient enrollment started in October 2023. the study aimed to evaluate the contribution of anterior femoral cutaneus nerve block to postoperative analgesia in total knee artroplasty.
The goal of this clinical trial is to compare analhesia effects of adductor canal blockade versus distal adductur canal blockade added anterior cutaneus nerve block in total knee arthroplasty.
Read more
The main questions it aims to answer are:
- question 1: does distal adductor canal blockade + anterior cutaneus nerve blokade superior analgesia then adductor canal block for undergoing TKP?
- question 2: does distal adductor canal blockade + anterior cutaneus nerve blokade decrease drain place pain on anterolateral face of knee?
Read the detailed description
Patients with American Society of Anesthesiologists classification status I-III scheduled for elective primary TKA using standard spinal anesthesia enroll for this trial. After surgery patient divided two groups: 1- adductor canal blockade 2- distal adductor canal blockade + anterior femoral cutaneus nerve blockade. At postoperative 3th, 10th, 24th hour VAS (visuel analouge scale), VAS move, incision plase pain-for top and down of patella, drain place pain, motor strenght for femoral nerve and siyatic nerve, first analjesic requirement time, opioid consumption, total analcesic requirement will be recorded.
- Conditions
- Pain Measurement, Knee Replacement Arthroplasty, Nerve Block
- Being tested
- Adductor canal blockade, Distal adductor canala blockade and anterior cutaneus nerve blockade
- Keywords
- anterior femoral cutaneus nerve block, distal adductor canal block, total knee arthroplasthy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adductor canal blockadeProcedure or surgery
Also called first control
VAS, VAS move, incision place pain for up and down to patella, drain place pain, motor strenght for femoral nerve and siyatic nerve muscles, side effects, first analgesic requirement time, opioid requirement, other analgesics
Distal adductor canala blockade and anterior cutaneus nerve blockadeProcedure or surgery
Also called study group
VAS, VAS move, incision place pain for up and down to patella, drain place pain, motor strenght for femoral nerve and siyatic nerve muscles, side effects, first analgesic requirement time, opioid requirement, other analgesics
| Study group | Role | What they receive |
|---|---|---|
| Adductor canal block | Active comparator | Usg guidance adductor canal block with %0.25 Bupivacaine 20 ml Receives: Procedure: Adductor canal blockade |
| Distal adductor canal block with anterior cutaneus nerve block | Active comparator | Usg guidance distal adductor canal block (%0.25 Bupivacaine 20 ml) with anterior cutaneus nerve block (%0.25 Bupivacaine 10 ml) Receives: Procedure: Distal adductor canala blockade and anterior cutaneus nerve blockade |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS (visuel analouge scale)
for postoperative pain evaluation after TKA surgery. The visual analogue scale (VAS) uses a 10 cm line with endpoint descriptors such as 'no pain' marked at the left end of the line and 'worst pain imaginable' marked at the right end.
Measured: postblock 3 hour,10 hour, 24 hour
drain place pain
do you have any pain on drain place? yes or no
Measured: postblock 3 hour,10 hour, 24 hour
Secondary outcomes (2)
VAS movement
Postoperative pain with knee moves evaluate with VAS, The visual analogue scale (VAS) uses a 10 cm line with endpoint descriptors such as 'no pain' marked at the left end of the line and 'worst pain imaginable' marked at the right end.
Measured: postblock 3 hour,10 hour, 24 hour
motor strenght
leg elevation and plantar flexion
Measured: postblock 3 hour,10 hour, 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start1 Oct 2023
- Primary completion31 Mar 2024
- Study completion30 Jun 2024
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 Pain MeasurementStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diskapi Teaching and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, derya özkan, Diskapi Teaching and Research Hospital
- Investigators
- Derya Ozkan, Study director, Study Principal Investigator Ankara Etlik City HospitalMüge Çakırca, doctor, Principal investigator, Study Principal Investigator Ankara Etlik City HospitalFunda Atar, doctor, Study chair, Study Principal Investigator Ankara Etlik City HospitalSerhan ünlü, doctor, Study chair, Study Principal Investigator Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06201195
- Sponsor's protocol ID
- AEŞH-EK1-2023-556
- Status last verified
- Nov 2025
- First submitted
- 25 Oct 2023
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bjorn S, Nielsen TD, Moriggl B, Hoermann R, Bendtsen TF. Anesthesia of the anterior femoral cutaneous nerves for total knee arthroplasty incision: randomized volunteer trial. Reg Anesth Pain Med. 2019 Dec 10:rapm-2019-100904. doi: 10.1136/rapm-2019-100904. Online ahead of print.
PubMed 31826920
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of Anterior Femoral Cutaneous Nerve Block to Postoperative Analgesia for Total Knee Replacement
- ClinicalTrials.gov ID
- NCT06201195
- Acronym / sponsor ID
- AEŞH-EK1-2023-556
- Conditions
- Pain Measurement, Knee Replacement Arthroplasty, Nerve Block
- Keywords
- anterior femoral cutaneus nerve block, distal adductor canal block, total knee arthroplasthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Diskapi Teaching and Research HospitalUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 11 Jan 2024 (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.
This prospective clinical study was approved by the institutional ethics committee on September 27, 2023, and patient enrollment started in October 2023. the study aimed to evaluate the contribution of anterior femoral cutaneus nerve block to postoperative analgesia in total knee artroplasty.
The goal of this clinical trial is to compare analhesia effects of adductor canal blockade versus distal adductur canal blockade added anterior cutaneus nerve block in total knee arthroplasty.
The main questions it aims to answer are:
- question 1: does distal adductor canal blockade + anterior cutaneus nerve blokade superior analgesia then adductor canal block for undergoing TKP?
- question 2: does distal adductor canal blockade + anterior cutaneus nerve blokade decrease drain place pain on anterolateral face of knee?
Detailed description
Patients with American Society of Anesthesiologists classification status I-III scheduled for elective primary TKA using standard spinal anesthesia enroll for this trial. After surgery patient divided two groups: 1- adductor canal blockade 2- distal adductor canal blockade + anterior femoral cutaneus nerve blockade. At postoperative 3th, 10th, 24th hour VAS (visuel analouge scale), VAS move, incision plase pain-for top and down of patella, drain place pain, motor strenght for femoral nerve and siyatic nerve, first analjesic requirement time, opioid consumption, total analcesic requirement will be recorded.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adductor canal block | Active comparator | Procedure: Adductor canal blockadeUsg guidance adductor canal block with %0.25 Bupivacaine 20 ml |
| Distal adductor canal block with anterior cutaneus nerve block | Active comparator | Procedure: Distal adductor canala blockade and anterior cutaneus nerve blockadeUsg guidance distal adductor canal block (%0.25 Bupivacaine 20 ml) with anterior cutaneus nerve block (%0.25 Bupivacaine 10 ml) |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Total knee artroplasty
- Spinal anesthesia
- ASA 1-3
Key exclusion criteria (3 listed)
- Bupivacaine allergy
- Coagulopathy
- Infection on injection site
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 |
|---|---|---|
| Adductor canal blockadeAlso: first controlVAS, VAS move, incision place pain for up and down to patella, drain place pain, motor strenght for femoral nerve and siyatic nerve muscles, side effects, first analgesic requirement time, opioid requirement, other analgesics | Procedure or surgery | Adductor canal block |
| Distal adductor canala blockade and anterior cutaneus nerve blockadeAlso: study groupVAS, VAS move, incision place pain for up and down to patella, drain place pain, motor strenght for femoral nerve and siyatic nerve muscles, side effects, first analgesic requirement time, opioid requirement, other analgesics | Procedure or surgery | Distal adductor canal block with anterior cutaneus nerve block |
Primary outcome
VAS (visuel analouge scale)
Time frame: postblock 3 hour,10 hour, 24 hour
for postoperative pain evaluation after TKA surgery. The visual analogue scale (VAS) uses a 10 cm line with endpoint descriptors such as 'no pain' marked at the left end of the line and 'worst pain imaginable' marked at the right end.
drain place pain
Time frame: postblock 3 hour,10 hour, 24 hour
do you have any pain on drain place? yes or no
2 secondary outcomes
VAS movement
Time frame: postblock 3 hour,10 hour, 24 hour
motor strenght
Time frame: postblock 3 hour,10 hour, 24 hour
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 19 Nov 2025.
- Background: PubMed 31826920Bjorn S, Nielsen TD, Moriggl B, Hoermann R, Bendtsen TF. Anesthesia of the anterior femoral cutaneous nerves for total knee arthroplasty incision: randomized volunteer trial. Reg Anesth Pain Med. 2019 Dec 10:rapm-2019-100904. doi: 10.1136/rapm-2019-100904. Online ahead of print.
- 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.
Derya Ozkan study director
Study Principal Investigator Ankara Etlik City Hospital
Müge Çakırca, doctor principal investigator
Study Principal Investigator Ankara Etlik City Hospital
Funda Atar, doctor study chair
Study Principal Investigator Ankara Etlik City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adductor canal blockade and Distal adductor canala blockade and anterior cutaneus nerve blockade in people with Pain Measurement and Knee Replacement Arthroplasty, run by Diskapi Teaching and Research Hospital 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 3 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 19 Nov 2025. 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.
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?
VAS (visuel analouge scale) (time frame: postblock 3 hour,10 hour, 24 hour). The study lists 2 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 NCT06201195, 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 19 Nov 2025.