- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07506629
Adductor Canal Block Methods in Bilateral Total Knee Arthroplasty
Comparison of Surgeon-Performed Intraoperative Adductor Canal Block and Ultrasound-Guided Anesthesiologist-Performed Block in Bilateral Total Knee Arthroplasty
This study aims to compare the analgesic efficacy of surgeon-performed intraoperative adductor canal block (ACB) and ultrasound-guided anesthesiologist-performed ACB in patients undergoing bilateral total knee arthroplasty (TKA). In a prospective, randomized paired design, each patient will receive surgeon-performed ACB on one knee and anesthesiologist-performed ACB on the contralateral knee.
The primary outcome is postoperative pain measured using the Numeric Rating Scale (NRS), and the study is designed to evaluate the non-inferiority of surgeon-performed ACB. Secondary outcomes include opioid consumption, time to first ambulation, length of hospital stay, postoperative complications, and patient-reported outcome measures (PROMs).
Additionally, postoperative ultrasound evaluation will be performed to assess the distribution pattern of local anesthetic within the adductor canal, including cross-sectional area and longitudinal spread. This study is expected to provide evidence regarding the clinical effectiveness and technical accuracy of surgeon-performed ACB in comparison with the conventional ultrasound-guided technique.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Kwan-Kyu Park, Professor
- Phone Number: +82-2-2228-2183
- Email: kkpark@yuhs.ac
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adult patients aged 19 years or older
- Patients scheduled for bilateral total knee arthroplasty
- Patients who provide written informed consent
Exclusion Criteria:
- Refusal to participate or inability to provide informed consent
- Neurological or psychiatric conditions affecting cooperation (e.g., dementia, delirium)
- Pre-existing neurological or anatomical abnormalities of the lower extremities
- Chronic opioid use or opioid dependence
- Coagulation disorders or contraindications to nerve block
- Pregnancy
- Cases in which ultrasound evaluation is technically not feasible
Study Plan
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 |
|---|---|
|
Experimental: Surgeon-Performed Adductor Canal Block
Adductor canal block performed intraoperatively by the surgeon using an anatomical landmark-based technique.
The injection is administered during surgery without ultrasound guidance using a standardized approach and the same type and volume of local anesthetic as the comparator.
|
An adductor canal block performed intraoperatively by the surgeon using an anatomical landmark-based technique.
The injection is administered at approximately 8 cm proximal to the distal femur, with the needle directed medially and posteriorly.
A total of 20 mL of 0.3% ropivacaine mixed with epinephrine is injected using a standardized approach without ultrasound guidance.
|
|
Active Comparator: Ultrasound-Guided Adductor Canal Block
Adductor canal block performed by an anesthesiologist under ultrasound guidance using real-time imaging.
The same concentration and volume of local anesthetic are administered using a standardized ultrasound-guided technique.
|
An adductor canal block performed by an anesthesiologist under ultrasound guidance.
The saphenous nerve and femoral artery within the adductor canal are identified using real-time imaging, and 20 mL of 0.3% ropivacaine mixed with epinephrine is injected using an in-plane technique.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain (Numeric Rating Scale)
Time Frame: Baseline, postoperative day 0 (afternoon), postoperative day 1 (morning and afternoon), and postoperative day 2 (morning)
|
Postoperative pain will be assessed using the Numeric Rating Scale (NRS, 0-10).
Pain scores will be recorded at predefined time points under resting conditions.
The primary analysis will evaluate the non-inferiority of surgeon-performed adductor canal block compared to ultrasound-guided adductor canal block.
|
Baseline, postoperative day 0 (afternoon), postoperative day 1 (morning and afternoon), and postoperative day 2 (morning)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4-2026-0060
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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