Total Knee Arthroplasty for GonarthrosisNCT07539467
"The Effect of Adductor Canal Block Performed With Postoperative Thigh Tourniquet Application on Pain After Total Knee Arthroplasty"
A study testing Tourniquet-Assisted Adductor Canal Block (T-ACB) grou and Standard Adductor Canal Block (S-ACB) in people with Total Knee Arthroplasty for Gonarthrosis, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial summary
The biggest fear for patients undergoing knee replacement surgery is that persistent pain felt at the back of the knee postoperatively. While regional anesthesia is generally successful at numbing the front of the knee, managing pain in the posterior (back) area is not always easy. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Total Knee Arthroplasty for Gonarthrosis
- What is being tested?
- Tourniquet-Assisted Adductor Canal Block (T-ACB) grou and Standard Adductor Canal Block (S-ACB)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2026to 16 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The biggest fear for patients undergoing knee replacement surgery is that persistent pain felt at the back of the knee postoperatively. While regional anesthesia is generally successful at numbing the front of the knee, managing pain in the posterior (back) area is not always easy. In this study, we tested a new method designed to alleviate pain in the back of the knee and improve patient comfort.
Read the 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.
- Conditions
- Total Knee Arthroplasty for Gonarthrosis
- Being tested
- Tourniquet-Assisted Adductor Canal Block (T-ACB) grou, Standard Adductor Canal Block (S-ACB)
- Keywords
- adductor canal block, Opioid consumption, Postoperative analgesia, Total knee arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tourniquet-Assisted Adductor Canal Block (T-ACB) grouProcedure or surgery
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.
Standard Adductor Canal Block (S-ACB)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard Adductor Canal Block Group (S-ACB) | Active comparator | 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. Receives: Procedure: Standard Adductor Canal Block (S-ACB) |
| Tourniquet-Assisted Adductor Canal Block Group (T-ACB) | Experimental | 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) Receives: Procedure: Tourniquet-Assisted Adductor Canal Block (T-ACB) grou |
What is being measured
The primary outcome is the main question the study is designed to answer.
This method aims to alleviate posterior knee pain and decrease overall VAS scores
Visual Analog Scale (VAS): A scale where patients rate their pain intensity from 0 (no pain) to 10 (unbearable pain).
Measured: At 3, 8, 12, and 24 hours post-block
Secondary outcomes (1)
To decrease cumulative opioid requirements and facilitate mobilization while preserving muscle strength
- Total Opioid Consumption Total Opioid Consumption (The total amount of morphine/tramadol required during the first 24 hours postoperatively).
- Preservation of Motor Function Preservation of Motor Function (Assessment of quadriceps muscle strength using the Bromage Scale).
- Time to First Mobilization Time to First Mobilization (The hour at which the patient first stood up or ambulated postoperatively).
Measured: at 3,8,12,24. post-block hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start1 Mar 2026
- Primary completion15 Apr 2026 (estimated)
- Study completion16 Apr 2026 (estimated)
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 Total Knee Arthroplasty for GonarthrosisStudies of the same condition, open and under way.
- More trials run by Ankara Etlik City HospitalThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Single group
- Model description
- "The control group consisted of patients who underwent the routine adductor canal block, whereas the tourniquet group included patients who received the block with the application of a tourniquet."
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Müge Çakırca, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07539467
- Sponsor's protocol ID
- AEŞH-EK-2025-245
- Status last verified
- Apr 2026
- First submitted
- 10 Apr 2026
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data Availability Statement: There are no plans to share individual participant data. Research findings will be reported as collective analyses in scientific journals and academic theses.
Publications
Sonawane K, Dixit H, Mistry T, Gurumoorthi P, Balavenkatasubramanian J. Anatomical and Technical Considerations of the Hi-PAC (Hi-Volume Proximal Adductor Canal) Block: A Novel Motor-Sparing Regional Analgesia Technique for Below-Knee Surgeries. Cureus. 2022 Feb 6;14(2):e21953. doi: 10.7759/cureus.21953. eCollection 2022 Feb.
PubMed 35282508
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "The Effect of Adductor Canal Block Performed With Postoperative Thigh Tourniquet Application on Pain After Total Knee Arthroplasty"
- ClinicalTrials.gov ID
- NCT07539467
- Acronym / sponsor ID
- AEŞH-EK-2025-245
- Conditions
- Total Knee Arthroplasty for Gonarthrosis
- Keywords
- adductor canal block, Opioid consumption, Postoperative analgesia, Total knee arthroplasty
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 15 Apr 2026 (estimated)
- Study completion
- 16 Apr 2026 (estimated)
- First posted
- 20 Apr 2026 (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.
The biggest fear for patients undergoing knee replacement surgery is that persistent pain felt at the back of the knee postoperatively. While regional anesthesia is generally successful at numbing the front of the knee, managing pain in the posterior (back) area is not always easy. In this study, we tested a new method designed to alleviate pain in the back of the knee and improve patient comfort.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- "The control group consisted of patients who underwent the routine adductor canal block, whereas the tourniquet group included patients who received the block with the application of a tourniquet."
| Arm | Type | Receives |
|---|---|---|
| Standard Adductor Canal Block Group (S-ACB) | Active comparator | Procedure: Standard Adductor Canal Block (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. |
| Tourniquet-Assisted Adductor Canal Block Group (T-ACB) | Experimental | Procedure: Tourniquet-Assisted Adductor Canal Block (T-ACB) grouParticipants 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) |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (8 listed)
- 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.
- The surgical duration exceeded 180 minutes.
- There was a known history of coagulopathy, peripheral neuropathy, or allergy to local anesthetics.
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 |
|---|---|---|
| Tourniquet-Assisted Adductor Canal Block (T-ACB) grouParticipants 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. | Procedure or surgery | Tourniquet-Assisted Adductor Canal Block Group (T-ACB) |
| Standard Adductor Canal Block (S-ACB)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. | Procedure or surgery | Standard Adductor Canal Block Group (S-ACB) |
Primary outcome
This method aims to alleviate posterior knee pain and decrease overall VAS scores
Time frame: At 3, 8, 12, and 24 hours post-block
Visual Analog Scale (VAS): A scale where patients rate their pain intensity from 0 (no pain) to 10 (unbearable pain).
1 secondary outcome
To decrease cumulative opioid requirements and facilitate mobilization while preserving muscle strength
Time frame: at 3,8,12,24. post-block hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Results publication: PubMed 35282508Sonawane K, Dixit H, Mistry T, Gurumoorthi P, Balavenkatasubramanian J. Anatomical and Technical Considerations of the Hi-PAC (Hi-Volume Proximal Adductor Canal) Block: A Novel Motor-Sparing Regional Analgesia Technique for Below-Knee Surgeries. Cureus. 2022 Feb 6;14(2):e21953. doi: 10.7759/cureus.21953. eCollection 2022 Feb.
- Individual participant dataSharing planned: No. Data Availability Statement: There are no plans to share individual participant data. Research findings will be reported as collective analyses in scientific journals and academic theses.
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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.
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 Tourniquet-Assisted Adductor Canal Block (T-ACB) grou and Standard Adductor Canal Block (S-ACB) in people with Total Knee Arthroplasty for Gonarthrosis, run by Ankara Etlik City 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 0 inclusion and 8 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: enrolling by invitation, as of the sponsor's last update on 20 Apr 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
This method aims to alleviate posterior knee pain and decrease overall VAS scores (time frame: At 3, 8, 12, and 24 hours post-block). 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 NCT07539467, 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 20 Apr 2026.