Knee OsteoarthritisNCT06188806
Investigation of the Effect of Proximal and Distal Adductor Canal Block in Knee Replacement Surgery
A study testing ADDUKTOR CANAL BLOCK in people with Knee Osteoarthritis, run by Umraniye Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
to investigate the effect of adductor canal block applied with two different approaches in the treatment of pain after TKA surgery on pain control and functional mobility. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- ADDUKTOR CANAL BLOCK
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Nov 2023to 30 Mar 2026
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Medications for unilateral TKA surgery
- Patients aged 18-85
- ASA 1-3
Who cannot join
- Patients under 18 years of age and over 85 years of age
- Patients with ASA 4 and above
- Patients with cognitive impairment
- Patients with application site infection
- Patients allergic to local anesthesia
- Patients receiving anticoagulant therapy
Show all 12Show fewer
- Patients with bleeding diathesis
- Patients with chronic opioid or substance use
- Patients with insulin-dependent diabetes mellitus
- patients with neuropathy
- patients with hepatic or renal failure
- Patients who do not accept the procedure to be applied
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Umraniye Education and Research Hospital
Istanbul, Umraniye, 34734
About this study
Official title: Investigation of the Effect of Proximal and Distal Adductor Canal Block on Pain Control and Functional Mobility in Total Knee Prosthesis Surgery Performed Under Spinal Anesthesia
to investigate the effect of adductor canal block applied with two different approaches in the treatment of pain after TKA surgery on pain control and functional mobility.
Read the detailed description
This prospective randomized trial is randomly divided into 3 groups using the method. Total knee arthroplasty is performed by the same surgical team.
is applied. The patients were divided into proximal ACB applied, distal ACB applied and control groups.
- Conditions
- Knee Osteoarthritis
- Being tested
- ADDUKTOR CANAL BLOCK, CONTROL GROUP
- Keywords
- adduktor canal block,knee artroplasti,postoperative pain
- Medical subject headings
- Osteoarthritis, Knee, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADDUKTOR CANAL BLOCKOther
All patients who will undergo adductor canal block are sedated with midazolam 0.03 mg/kg in the preoperative preparation room, after standard monitoring. After 2-3 ml skin infiltration with 2% lidocaine under sterile conditions, a block is applied under USG guidance.To verify block success, sensory function is assessed by pinprick testing along the saphenous nerve distribution by comparing the pinprick sensation to the unaffected limb.All patients are monitored in the operating room and in a sitting position, 10-20 mg (2-4 ml) of heavy marcaine (0.5% bupivacaine hydrochloride and dextrose monohydrate) is applied to the subarachnoid space by entering the L3-4 or L4-5 space with a 25-gauge Whitrace needle.For postoperative multimodal analgesia, which is routinely applied to all patients, intravenous PCA (patient controlled analgesia )tramadol and paracetamol 10 mg / kg iv (8 hours apart) will be given.
CONTROL GROUPOther
No nerve block procedure is applied to patients.All patients are monitored in the operating room and in a sitting position, 10-20 mg (2-4 ml) of heavy marcaine (0.5% bupivacaine hydrochloride and dextrose monohydrate) is applied to the subarachnoid space by entering the L3-4 or L4-5 space with a 25-gauge Whitrace needle.For postoperative multimodal analgesia, which is routinely applied to all patients, intravenous PCA (patient controlled analgesia) tramadol 50 mg at 10 mg / hour basal rate after loading (20 mg bolus dose + 30 minutes lock time) and paracetamol 10 mg / kg iv (8 hours apart) will be given.
| Study group | Role | What they receive |
|---|---|---|
| PROXİMAL ADDUKTOR CANAL BLOCK GROUP | Active comparator | Patients are placed in the supine position and a high-frequency linear probe is inserted for a cross-sectional image of the groin and thigh. The femoral nerve is identified in the short axis near the inguinal crease and the ultrasound transducer is placed caudally beyond the femoral triangle. The location of the proximal block is determined where the superficial femoral artery passes under the medial border of the sartorius muscle (usually 8-12 cm distal to the inguinal crease). Using the in-plane technique, a 100 mm peripheral nerve block needle is advanced until the tip of the needle passes the sartorius muscle and enters the adductor canal from the lateral side of the superficial femoral artery, and 20 mL 0.375% Bupivacaine is administered. To verify block success, sensory function is assessed by pinprick testing along the saphenous nerve distribution by comparing the pinprick sensation to the unaffected limb. Receives: Other: ADDUKTOR CANAL BLOCK |
| DİSTAL ADDUKTOR CANAL BLOCK GROUP | Active comparator | Patients are placed in the supine position, the mid-thigh point is determined as half the distance between the groin crease and the top of the patella. After the mid-thigh mark is marked with a sterile marking pen, the ultrasound transducer is positioned for a transverse view of the adductor canal into the mid-thigh. Under USG imaging, the femoral artery and saphenous nerve are identified. The distal position is determined where the USG probe moves away from the sartorius muscle of the femoral artery and proceeds deep into the adductor hiatus, and a 100 mm block needle passes the sartorius muscle with an in plane technique and 20 mL 0.375% Bupivacaine is administered to the lateral side of the femoral artery and saphenous nerve. Receives: Other: ADDUKTOR CANAL BLOCK |
| CONTROL GROUP | Sham comparator | No nerve block procedure is applied to patients. Receives: Other: CONTROL GROUP |
What is being measured
The primary outcome is the main question the study is designed to answer.
VISUAL ANALOGUE SCALE(VAS)
VAS pain score was evaluated as "no pain" (score=0) and "worst pain" (score=10) and was divided into 3 groups according to the World Health Organization's pain intensity scale: score <3 mild pain, 3-6 mild-moderate. degree pain and >6 moderate-severe pain.
Measured: POSTOPERATIVE 6, 12 AND 24 HOURS
Secondary outcomes (3)
first mobilization time
The first postoperative mobilization hours of the patients will be recorded.
Measured: within postoperative 24 hours
length of hospital stay
The time between patients' admission and discharge will be recorded.
Measured: ONE WEEK
opioid use
Intravenous PCA will be applied to each patient and the total tramadol dose spent will be calculated.intravenous PCA (patient controlled analgesia) tramadol 50 mg at 10 mg / hour basal rate after loading (20 mg bolus dose + 30 minutes lock time)
Measured: within postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start10 Nov 2023
- Primary completion27 Feb 2026
- Study completion30 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee 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
- Model description
- three groups Group 1: proximal ACB (n:26) Group 2: distal ACB(n:26) Group 3: Control group (n:26)
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umraniye Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Zeliha Alicikus, Umraniye Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06188806
- Sponsor's protocol ID
- URH-AR-ZT-06
- Status last verified
- Oct 2026
- First submitted
- 18 Dec 2023
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Proximal and Distal Adductor Canal Block on Pain Control and Functional Mobility in Total Knee Prosthesis Surgery Performed Under Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT06188806
- Acronym / sponsor ID
- URH-AR-ZT-06
- Conditions
- Knee Osteoarthritis
- Keywords
- adduktor canal block,knee artroplasti,postoperative pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Umraniye Education and Research HospitalOther government
- Study start
- 10 Nov 2023 (actual)
- Primary completion
- 27 Feb 2026 (actual)
- Study completion
- 30 Mar 2026 (actual)
- First posted
- 3 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.
to investigate the effect of adductor canal block applied with two different approaches in the treatment of pain after TKA surgery on pain control and functional mobility.
Detailed description
This prospective randomized trial is randomly divided into 3 groups using the method. Total knee arthroplasty is performed by the same surgical team.
is applied. The patients were divided into proximal ACB applied, distal ACB applied and control groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- three groups Group 1: proximal ACB (n:26) Group 2: distal ACB(n:26) Group 3: Control group (n:26)
| Arm | Type | Receives |
|---|---|---|
| PROXİMAL ADDUKTOR CANAL BLOCK GROUP | Active comparator | Other: ADDUKTOR CANAL BLOCKPatients are placed in the supine position and a high-frequency linear probe is inserted for a cross-sectional image of the groin and thigh. The femoral nerve is identified in the short axis near the inguinal crease and the ultrasound transducer is placed caudally beyond the femoral triangle. The location of the proximal block is determined where the superficial femoral artery passes under the medial border of the sartorius muscle (usually 8-12 cm distal to the inguinal crease). Using the in-plane technique, a 100 mm peripheral nerve block needle is advanced until the tip of the needle passes the sartorius muscle and enters the adductor canal from the lateral side of the superficial femoral artery, and 20 mL 0.375% Bupivacaine is administered. To verify block success, sensory function is assessed by pinprick testing along the saphenous nerve distribution by comparing the pinprick sensation to the unaffected limb. |
| DİSTAL ADDUKTOR CANAL BLOCK GROUP | Active comparator | Other: ADDUKTOR CANAL BLOCKPatients are placed in the supine position, the mid-thigh point is determined as half the distance between the groin crease and the top of the patella. After the mid-thigh mark is marked with a sterile marking pen, the ultrasound transducer is positioned for a transverse view of the adductor canal into the mid-thigh. Under USG imaging, the femoral artery and saphenous nerve are identified. The distal position is determined where the USG probe moves away from the sartorius muscle of the femoral artery and proceeds deep into the adductor hiatus, and a 100 mm block needle passes the sartorius muscle with an in plane technique and 20 mL 0.375% Bupivacaine is administered to the lateral side of the femoral artery and saphenous nerve. |
| CONTROL GROUP | Sham comparator | Other: CONTROL GROUPNo nerve block procedure is applied to patients. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Medications for unilateral TKA surgery
Key exclusion criteria (12 listed)
- Patients under 18 years of age and over 85 years of age
- Patients with ASA 4 and above
- Patients with cognitive impairment
- Patients with application site infection
- Patients allergic to local anesthesia
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 |
|---|---|---|
| ADDUKTOR CANAL BLOCKAll patients who will undergo adductor canal block are sedated with midazolam 0.03 mg/kg in the preoperative preparation room, after standard monitoring. After 2-3 ml skin infiltration with 2% lidocaine under sterile conditions, a block is applied under USG guidance.To verify block success, sensory function is assessed by pinprick testing along the saphenous nerve distribution by comparing the pinprick sensation to the unaffected limb.All patients are monitored in the operating room and in a sitting position, 10-20 mg (2-4 ml) of heavy marcaine (0.5% bupivacaine hydrochloride and dextrose monohydrate) is applied to the subarachnoid space by entering the L3-4 or L4-5 space with a 25-gauge Whitrace needle.For postoperative multimodal analgesia, which is routinely applied to all patients, intravenous PCA (patient controlled analgesia )tramadol and paracetamol 10 mg / kg iv (8 hours apart) will be given. | Other | DİSTAL ADDUKTOR CANAL BLOCK GROUP, PROXİMAL ADDUKTOR CANAL BLOCK GROUP |
| CONTROL GROUPNo nerve block procedure is applied to patients.All patients are monitored in the operating room and in a sitting position, 10-20 mg (2-4 ml) of heavy marcaine (0.5% bupivacaine hydrochloride and dextrose monohydrate) is applied to the subarachnoid space by entering the L3-4 or L4-5 space with a 25-gauge Whitrace needle.For postoperative multimodal analgesia, which is routinely applied to all patients, intravenous PCA (patient controlled analgesia) tramadol 50 mg at 10 mg / hour basal rate after loading (20 mg bolus dose + 30 minutes lock time) and paracetamol 10 mg / kg iv (8 hours apart) will be given. | Other | CONTROL GROUP |
Primary outcome
VISUAL ANALOGUE SCALE(VAS)
Time frame: POSTOPERATIVE 6, 12 AND 24 HOURS
VAS pain score was evaluated as "no pain" (score=0) and "worst pain" (score=10) and was divided into 3 groups according to the World Health Organization's pain intensity scale: score <3 mild pain, 3-6 mild-moderate. degree pain and >6 moderate-severe pain.
3 secondary outcomes
first mobilization time
Time frame: within postoperative 24 hours
length of hospital stay
Time frame: ONE WEEK
opioid use
Time frame: within postoperative 24 hours
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 9 Oct 2026.
Related trials for Knee Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
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 ADDUKTOR CANAL BLOCK in people with Knee Osteoarthritis, run by Umraniye Education 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 12 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 9 Oct 2026. 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. Some participants in this study may receive a placebo. 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?
VISUAL ANALOGUE SCALE(VAS) (time frame: POSTOPERATIVE 6, 12 AND 24 HOURS). 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 9 Oct 2026.