- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06188806
Investigation of the Effect of Proximal and Distal Adductor Canal Block in Knee Replacement Surgery
November 16, 2025 updated by: Zeliha Alicikus, Umraniye Education and Research Hospital
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
78
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Zeliha TUNCEL
- Phone Number: +90 505 357 74 83
- Email: zelihalara@yahoo.com
Study Locations
-
-
Umraniye
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Istanbul, Umraniye, Turkey (Türkiye), 34734
- Recruiting
- Umraniye Education and Research Hospital
-
Contact:
- ZELİHA TUNCEL, ass prof
- Phone Number: 5053577483
- Email: zelihalara@yahoo.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
Medications for unilateral TKA surgery
- Patients aged 18-85
- ASA 1-3
Exclusion Criteria:
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: PROXİMAL ADDUKTOR CANAL BLOCK GROUP
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.
|
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.
|
|
Active Comparator: DİSTAL ADDUKTOR CANAL BLOCK GROUP
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.
|
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.
|
|
Sham Comparator: CONTROL GROUP
No nerve block procedure is applied to patients.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
POSTOPERATIVE 6, 12 AND 24 HOURS
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
first mobilization time
Time Frame: within postoperative 24 hours
|
The first postoperative mobilization hours of the patients will be recorded.
|
within postoperative 24 hours
|
|
length of hospital stay
Time Frame: ONE WEEK
|
The time between patients' admission and discharge will be recorded.
|
ONE WEEK
|
|
opioid use
Time Frame: within postoperative 24 hours
|
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)
|
within postoperative 24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 10, 2023
Primary Completion (Estimated)
February 27, 2026
Study Completion (Estimated)
March 30, 2026
Study Registration Dates
First Submitted
December 18, 2023
First Submitted That Met QC Criteria
December 18, 2023
First Posted (Actual)
January 3, 2024
Study Record Updates
Last Update Posted (Actual)
November 19, 2025
Last Update Submitted That Met QC Criteria
November 16, 2025
Last Verified
November 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Musculoskeletal Diseases
- Postoperative Complications
- Pathologic Processes
- Arthritis
- Joint Diseases
- Rheumatic Diseases
- Osteoarthritis
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Pain, Postoperative
- Osteoarthritis, Knee
- Investigative Techniques
- Epidemiologic Research Design
- Epidemiologic Methods
- Research Design
- Methods
- Control Groups
Other Study ID Numbers
- URH-AR-ZT-06
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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