- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07539467
"The Effect of Adductor Canal Block Performed With Postoperative Thigh Tourniquet Application on Pain After Total Knee Arthroplasty"
Study Overview
Status
Conditions
Detailed Description
A New Solution for "Posterior" Pain After Knee Surgery To ensure patient comfort following knee replacement surgery, we routinely use ultrasound-guided injections of local anesthetics around the nerves of the knee to block pain signals. While this method is highly successful at eliminating pain in the anterior (front) part of the knee, studies have shown that the medication often fails to reach the deep posterior (back) compartments, leaving patients with persistent discomfort in that area.
In this study, we addressed a fundamental question: "How can we ensure the medication reaches those hard-to-access depths at the very back of the knee?"
To achieve this, we developed a simple yet highly effective technique. We applied a tourniquet-similar to a blood pressure cuff-to the upper leg and inflated it for a short period. We administered the medication, then released the tourniquet and performed a second application.
This controlled pressure on the upper leg acted as a barrier, preventing the anesthetic from migrating upward toward the groin and instead "pushing" it into the narrow passages at the back of the knee. By doing so, we enabled the medication to reach deep points that it typically cannot access on its own.
The Results:
As a result of this technique, we observed a significant reduction in stubborn posterior knee pain. Furthermore, our patients required substantially fewer potent painkillers (analgesics) during their recovery.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ankara, Turkey (Türkiye), 06690
- Ankara Etlik Şehir Hastanesi
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria Patients aged 40-85 years, with a BMI of 18-35 kg/m², and an ASA physical status of I-III who underwent total knee arthroplasty (TKA) under spinal anesthesia were included. Eligible participants were those who volunteered to participate and provided written informed consent.
Exclusion Criteria
To ensure methodological standardization, the following cases were excluded:
Patients undergoing revision surgery.
Those undergoing unicompartmental (unicondylar) knee replacement, as the severity of surgical trauma differs from total replacement.
Bilateral cases, to prevent potential bias in assessing postoperative opioid consumption and pain scores.
Additionally, patients were excluded if:
The surgical duration exceeded 180 minutes.
There was a known history of coagulopathy, peripheral neuropathy, or allergy to local anesthetics.
The spinal anesthesia was insufficient, requiring a conversion to general anesthesia.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Standard Adductor Canal Block Group (S-ACB)
Participants received a standard ultrasound-guided distal adductor canal block.
During the procedure, 20 mL of 0.25% bupivacaine was injected.
In this group, no tourniquet application or additional pressure modification was performed prior to the injection.
The technique relied on the natural and passive distribution of the local anesthetic within the canal.
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Participants received a standard ultrasound-guided distal adductor canal block.
During the procedure, 20 mL of 0.25% bupivacaine was injected in a single dose without any tourniquet modification or additional pressure application.
The technique relied on the natural, passive, and anatomical distribution of the local anesthetic within the adductor canal.
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Experimental: Tourniquet-Assisted Adductor Canal Block Group (T-ACB)
Participants received an ultrasound-guided distal adductor canal block.
During the procedure, a pneumatic tourniquet placed on the proximal thigh was inflated for 3-5 minutes (at a pressure of approximately 142-202 mmHg), and 20 mL of 0.25% bupivacaine was injected.
Following this, the tourniquet was deflated, and a second 20 mL dose of 0.25% bupivacaine was administered.
The aim of this modification was to enhance the distribution of the local anesthetic through the adductor hiatus toward the neural networks of the posterior knee (posterior fascial planes)
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Participants received an ultrasound-guided distal adductor canal block.
The procedure was performed in two stages: First, a pneumatic tourniquet placed on the proximal thigh was inflated for 3-5 minutes (at a pressure of approximately 142-202 mmHg), during which 20 mL of 0.25% bupivacaine was injected.
Subsequently, the tourniquet was deflated, and an additional 20 mL of 0.25% bupivacaine was administered, reaching a total volume of 40 mL.
This technique aimed to enhance the distribution of the local anesthetic through the adductor hiatus to the popliteal plexus at the posterior aspect of the knee.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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This method aims to alleviate posterior knee pain and decrease overall VAS scores
Time Frame: At 3, 8, 12, and 24 hours post-block
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Visual Analog Scale (VAS): A scale where patients rate their pain intensity from 0 (no pain) to 10 (unbearable pain).
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At 3, 8, 12, and 24 hours post-block
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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To decrease cumulative opioid requirements and facilitate mobilization while preserving muscle strength
Time Frame: at 3,8,12,24. post-block hours
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at 3,8,12,24. post-block hours
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
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
Other Study ID Numbers
- AEŞH-EK-2025-245
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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