Total Knee AnthroplastyNCT07367009
Effect of Combined Adductor Canal and AFCN Block on Postoperative Inflammation
An observational study of Total Knee Anthroplasty, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this thesis is to evaluate the effects of adding an anterior femoral cutaneous nerve (AFCN) block to the adductor canal block used for postoperative analgesia after total knee arthroplasty on the postoperative inflammatory response, as assessed by inflammatory biomarkers including NLR, PLR, AISI, and CAR. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Knee Anthroplasty
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Jan 2026to 30 Jan 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 18 years and older, scheduled for elective unilateral total knee arthroplasty under spinal anesthesia (SA), classified as American Society of Anesthesiologists (ASA) physical status I-III, and who provided written informed consent after being informed one day before surgery on the ward, will be included.
Who may be able to join
- • Patients scheduled for elective unilateral total knee arthroplasty under spinal anesthesia
- Aged 18 years and older
- Body mass index (BMI) <40 kg/m²
- ASA physical status I-III
- Provision of written informed consent
Who cannot join
- Revision or bilateral surgery
- General anesthesia or conversion to general anesthesia due to failed block
- BMI ≥40 kg/m²
- ASA physical status >III
- Local infection, hematoma, previous surgery, or deformity at the block site
- Coagulopathy or history of hematologic, renal, or hepatic disease; advanced respiratory or cardiac failure; malignancy
Show all 11Show fewer
- Use of anticoagulant therapy
- History of local anesthetic allergy or toxicity
- Impaired cooperation, Alzheimer's disease, dementia, psychiatric or neurological disorders, or language/communication barriers
- Chronic analgesic use, chronic alcohol consumption, or substance abuse
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Fatih Sultan Mehmet Training and Research Hospital
Istanbul, ataşehir, 34752
About this study
Official title: The Effect of the Combination of Adductor Canal Block and Anterior Femoral Cutaneous Nerve Block on Postoperative Inflammatory Biomarkers in Total Knee Arthroplasty
The aim of this thesis is to evaluate the effects of adding an anterior femoral cutaneous nerve (AFCN) block to the adductor canal block used for postoperative analgesia after total knee arthroplasty on the postoperative inflammatory response, as assessed by inflammatory biomarkers including NLR, PLR, AISI, and CAR.
Read the detailed description
Total knee arthroplasty (TKA) is a common and effective surgical intervention for advanced-stage knee osteoarthritis. However, postoperative pain remains a significant issue affecting the recovery process, opioid requirements, and patient satisfaction. Tissue injury resulting from surgical trauma triggers an inflammatory response that leads to pain. During this process, released mediators activate nerve endings, and the severity of inflammation is generally correlated with pain intensity.
Multimodal analgesia strategies are widely used for postoperative pain management. Peripheral nerve blocks reduce pain scores and opioid consumption, thereby facilitating early mobilization. The adductor canal block is a commonly used technique after knee surgery, providing analgesia to the anteromedial region of the knee while preserving quadriceps muscle strength. However, this block may not adequately anesthetize the anterior femoral cutaneous nerve (AFCN), which innervates the anterior aspect of the thigh. Therefore, an anterior femoral cutaneous nerve block is routinely added to the adductor canal block to improve control of anterior knee pain.
Recent studies have demonstrated that regional anesthesia techniques reduce the inflammatory response, as reflected by biomarkers such as the neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR). This reduction in inflammatory markers has been shown to attenuate the surgical stress response and accelerate wound healing. However, the number of studies evaluating the effects of peripheral nerve blocks on biomarkers such as NLR, PLR, aggregate index of systemic inflammation (AISI), and C-reactive protein/albumin ratio (CAR) in knee surgery remains limited.
In our clinic, the choice of anesthesia technique in daily practice is determined based on the surgical site, type of procedure, patient positioning, and the experience of the anesthesia team. In patients undergoing total knee arthroplasty, ultrasound-guided adductor canal block combined with an anterior femoral cutaneous nerve block is routinely performed for postoperative pain management. The efficacy and safety of both blocks have been demonstrated in regional anesthesia guidelines and previous studies.
The primary outcome of this observational study is to evaluate the effect of adding an anterior femoral cutaneous nerve block to the adductor canal block on the inflammatory response, as assessed by biomarkers such as NLR, PLR, AISI, and CAR, in patients undergoing total knee arthroplasty. Secondary outcomes include postoperative opioid consumption, incidence of nausea and vomiting, early mobilization, and wound healing.
In our clinic, both general and regional anesthesia techniques are applied for knee arthroplasty according to patient suitability. Among regional anesthesia techniques, spinal anesthesia and peripheral nerve blocks are routinely preferred for both anesthesia and analgesia management based on the decision of an experienced anesthesiologist.
This study was designed as a prospective observational study and will be conducted at Fatih Sultan Mehmet Training and Research Hospital between January 2026 and January 2027 following approval by the local ethics committee. Patients aged 18 years or older, scheduled for elective unilateral total knee arthroplasty under spinal anesthesia (SA), classified as American Society of Anesthesiologists (ASA) physical status I-III, and who provide written informed consent after being informed one day before surgery on the ward will be included. Based on a power analysis performed using G*Power version 3.1.9.4 with a power of 80% and a type I error rate of 5%, a total of 60 patients is planned to be enrolled.
Exclusion criteria include emergency surgery; revision or bilateral procedures; general anesthesia or conversion to general anesthesia due to failed regional block; body mass index (BMI) ≥35 kg/m²; ASA physical status >III; local infection, hematoma, previous surgery, or deformity at the block site; coagulation disorders; history of hematologic, renal, or hepatic disease; advanced respiratory or cardiac failure; malignancy; anticoagulant therapy; history of local anesthetic allergy or toxicity; impaired cooperation; Alzheimer's disease; dementia; psychiatric or neurological disorders; language or communication barriers; chronic analgesic use; chronic alcohol consumption; substance abuse; and refusal to participate.
Demographic data (age, sex, ASA status, BMI), comorbidities, and routinely assessed preoperative laboratory parameters-including hemoglobin, hematocrit, white blood cell count (WBC), platelet count, PLR, NLR, C-reactive protein (CRP), and albumin levels-will be recorded for all included patients. Additionally, the CRP/albumin ratio (CAR) and the aggregate index of systemic inflammation (AISI = platelet × neutrophil × monocyte / lymphocyte) will be calculated and documented.
Upon arrival in the operating room, standard monitoring-including electrocardiography (ECG), noninvasive blood pressure, peripheral oxygen saturation (SpO₂), and body temperature-will be applied. Following monitoring and premedication with intravenous midazolam (0.02 mg/kg), spinal anesthesia will be performed. Under sterile conditions in the sitting position, a 25-gauge spinal needle will be inserted at the L3-L4 interspace. After confirmation of clear cerebrospinal fluid flow, 15 mg of 0.5% hyperbaric bupivacaine will be injected. Patients will then be placed in the supine position, and sensory block level (pinprick test) and motor block (Bromage score) will be assessed. Surgery will be initiated in patients achieving a sensory block at or above the T12 level and a Bromage score of 2. Hemodynamic parameters (heart rate, systolic, diastolic, and mean arterial pressure), body temperature, and SpO₂ values will be recorded at 20-minute intervals intraoperatively.
In our clinic, there is no standardized anesthesia or postoperative analgesia protocol; the choice is based on the surgical site, type of surgery, and clinician experience. Following total knee arthroplasty, ultrasound-guided peripheral nerve blocks may be used for postoperative analgesia according to anesthesiologist preference. The combination of adductor canal block and anterior femoral cutaneous nerve block is commonly preferred. At the end of surgery, while the patient is in the supine position, ultrasound-guided adductor canal and AFCN blocks will be performed. For the adductor canal block, 15 mL of 0.25% bupivacaine will be injected around the femoral artery beneath the sartorius muscle at the mid-thigh level. Subsequently, the AFCN block will be completed by injecting 10 mL of 0.25% bupivacaine superficial to the sartorius muscle at the same level. This combination provides effective analgesia for the anterior and medial aspects of the knee while preserving quadriceps muscle strength and allowing early mobilization.
All patients will receive 1 g of intravenous paracetamol as part of standard postoperative analgesia prophylaxis 20 minutes before the end of surgery. At the end of surgery, patient-controlled analgesia (PCA) with tramadol will be prepared using a 15 mg bolus dose and a 20-minute lockout interval and initiated in the post-anesthesia care unit (PACU). Surgery duration, anesthesia duration, and tourniquet time will be recorded.
Postoperatively, patients will be monitored in the PACU. Sensory block level, hemodynamic parameters, SpO₂ values, and pain scores at rest and during movement will be recorded at 0, 15, and 30 minutes in the PACU, and at 2, 4, 8, 12, and 24 hours on the ward. Nausea and vomiting, sedation level, and quadriceps muscle strength will also be documented. Pain intensity will be assessed using the 10-point Numeric Rating Scale (NRS; 0 = no pain, 10 = worst imaginable pain). Nausea and vomiting severity will be evaluated using a 5-point scale. Patients with an Aldrete score ≥9 and postoperative NRS <4 will be transferred to the ward.
Quadriceps muscle strength will be evaluated as follows: normal strength (score 0), mild weakness (score 1), and severe weakness (score 2). Scores of 1 and 2 will be considered quadriceps weakness.
Postoperative analgesia with tramadol PCA will be continued on the ward. Patients with an NRS score ≥4 will receive 50 mg intravenous dexketoprofen as rescue analgesia. Nausea and vomiting will be treated with intravenous ondansetron and dexamethasone as needed.
Total tramadol consumption, number of PCA demands, time to first rescue analgesic requirement, additional antiemetic use, and block-related complications will be recorded. Laboratory parameters will be recorded at postoperative 12 and 24 hours. Patients will be divided into two subgroups based on receipt of peripheral nerve blocks. Surgical site infection will be evaluated on postoperative days 15 and 30.
This study will document procedures routinely performed in clinical practice and will not impose any additional cost on patients or the institution.
- Conditions
- Total Knee Anthroplasty
- Keywords
- total knee arthroplasty, adductor canal block, anterior femoral cutaneous nerve block, postoperative analgesia, inflammatory biomarkers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients who peripheral nerve block applied | patients who adductor canal block and anterior femoral cutaneous nerve block applied | |
| patients without peripheral nerve block | patients who do not receive adductor canal block and anterior femoral cutaneous nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of post operative inflammatuar markes
The primary objective of this observational study is to evaluate the effect of adding an anterior femoral cutaneous nerve block to the adductor canal block on the inflammatory response, as assessed by biomarkers such as NLR, PLR, AISI, and CAR, in patients undergoing total knee arthroplasty.
Measured: it will be recorded at 0, 15, and 30 minutes in the PACU, and at 2, 4, 8, 12, and 24 hours on the ward.
Secondary outcomes (1)
postoperative opioid consumption, wound healing
The secondary outcomes are to investigate the effects of this block combination on postoperative opioid consumption, the incidence of nausea and vomiting, early mobilization, and wound healing
Measured: it will be recorded at 0, 15, and 30 minutes in the PACU, and at 2, 4, 8, 12, and 24 hours on the ward.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start19 Jan 2026
- Primary completion20 Jan 2027 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Total Knee AnthroplastyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Fatih Sultan Mehmet Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selin Taşçı, Fatih Sultan Mehmet Training and Research Hospital
- Investigators
- oznur demiroluk, as prof, Study director, fatih sultan mehmet traing and research hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07367009
- Sponsor's protocol ID
- FSMTRH-ST-01
- Status last verified
- Jan 2026
- First submitted
- 17 Jan 2026
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Razzaz M.; Youssif G.; Wahba S.; Mohamed S.; Mohamed A. Analgesic efficacy of ultrasound guided anterior femoral cutaneous nerve block (AFCNB) plus femoral triangle block (FTB) vs. adductor canal block (ACB) in total knee arthroplasty, Anaesthesia, Pain & Intensive Care, 2025
Domagalska M, Ciftsi B, Janusz P, Reysner T, Kolasinski J, Wieczorowska-Tobis K, Kowalski G. The neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR) levels following erector spinae plane block (ESPB) in posterior lumbar decompression: a randomized, controlled trial. Eur Spine J. 2023 Dec;32(12):4192-4199. doi: 10.1007/s00586-023-07913-z. Epub 2023 Sep 5.
PubMed 37668689Domagalska M, Reysner T, Kowalski G, Daroszewski P, Mularski A, Wieczorowska-Tobis K. Pain Management, Functional Recovery, and Stress Response Expressed by NLR and PLR after the iPACK Block Combined with Adductor Canal Block for Total Knee Arthroplasty-A Prospective, Randomised, Double-Blinded Clinical Trial. J Clin Med. 2023 Nov 14;12(22):7088. doi: 10.3390/jcm12227088.
PubMed 38002702
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Combination of Adductor Canal Block and Anterior Femoral Cutaneous Nerve Block on Postoperative Inflammatory Biomarkers in Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT07367009
- Acronym / sponsor ID
- FSMTRH-ST-01
- Conditions
- Total Knee Anthroplasty
- Keywords
- total knee arthroplasty, adductor canal block, anterior femoral cutaneous nerve block, postoperative analgesia, inflammatory biomarkers
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fatih Sultan Mehmet Training and Research HospitalUniversity, hospital or other
- Study start
- 19 Jan 2026 (actual)
- Primary completion
- 20 Jan 2027 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 26 Jan 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 aim of this thesis is to evaluate the effects of adding an anterior femoral cutaneous nerve (AFCN) block to the adductor canal block used for postoperative analgesia after total knee arthroplasty on the postoperative inflammatory response, as assessed by inflammatory biomarkers including NLR, PLR, AISI, and CAR.
Detailed description
Total knee arthroplasty (TKA) is a common and effective surgical intervention for advanced-stage knee osteoarthritis. However, postoperative pain remains a significant issue affecting the recovery process, opioid requirements, and patient satisfaction. Tissue injury resulting from surgical trauma triggers an inflammatory response that leads to pain. During this process, released mediators activate nerve endings, and the severity of inflammation is generally correlated with pain intensity.
Multimodal analgesia strategies are widely used for postoperative pain management. Peripheral nerve blocks reduce pain scores and opioid consumption, thereby facilitating early mobilization. The adductor canal block is a commonly used technique after knee surgery, providing analgesia to the anteromedial region of the knee while preserving quadriceps muscle strength. However, this block may not adequately anesthetize the anterior femoral cutaneous nerve (AFCN), which innervates the anterior aspect of the thigh. Therefore, an anterior femoral cutaneous nerve block is routinely added to the adductor canal block to improve control of anterior knee pain.
Recent studies have demonstrated that regional anesthesia techniques reduce the inflammatory response, as reflected by biomarkers such as the neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR). This reduction in inflammatory markers has been shown to attenuate the surgical stress response and accelerate wound healing. However, the number of studies evaluating the effects of peripheral nerve blocks on biomarkers such as NLR, PLR, aggregate index of systemic inflammation (AISI), and C-reactive protein/albumin ratio (CAR) in knee surgery remains limited.
In our clinic, the choice of anesthesia technique in daily practice is determined based on the surgical site, type of procedure, patient positioning, and the experience of the anesthesia team. In patients undergoing total knee arthroplasty, ultrasound-guided adductor canal block combined with an anterior femoral cutaneous nerve block is routinely performed for postoperative pain management. The efficacy and safety of both blocks have been demonstrated in regional anesthesia guidelines and previous studies.
The primary outcome of this observational study is to evaluate the effect of adding an anterior femoral cutaneous nerve block to the adductor canal block on the inflammatory response, as assessed by biomarkers such as NLR, PLR, AISI, and CAR, in patients undergoing total knee arthroplasty. Secondary outcomes include postoperative opioid consumption, incidence of nausea and vomiting, early mobilization, and wound healing.
In our clinic, both general and regional anesthesia techniques are applied for knee arthroplasty according to patient suitability. Among regional anesthesia techniques, spinal anesthesia and peripheral nerve blocks are routinely preferred for both anesthesia and analgesia management based on the decision of an experienced anesthesiologist.
This study was designed as a prospective observational study and will be conducted at Fatih Sultan Mehmet Training and Research Hospital between January 2026 and January 2027 following approval by the local ethics committee. Patients aged 18 years or older, scheduled for elective unilateral total knee arthroplasty under spinal anesthesia (SA), classified as American Society of Anesthesiologists (ASA) physical status I-III, and who provide written informed consent after being informed one day before surgery on the ward will be included. Based on a power analysis performed using G*Power version 3.1.9.4 with a power of 80% and a type I error rate of 5%, a total of 60 patients is planned to be enrolled.
Exclusion criteria include emergency surgery; revision or bilateral procedures; general anesthesia or conversion to general anesthesia due to failed regional block; body mass index (BMI) ≥35 kg/m²; ASA physical status >III; local infection, hematoma, previous surgery, or deformity at the block site; coagulation disorders; history of hematologic, renal, or hepatic disease; advanced respiratory or cardiac failure; malignancy; anticoagulant therapy; history of local anesthetic allergy or toxicity; impaired cooperation; Alzheimer's disease; dementia; psychiatric or neurological disorders; language or communication barriers; chronic analgesic use; chronic alcohol consumption; substance abuse; and refusal to participate.
Demographic data (age, sex, ASA status, BMI), comorbidities, and routinely assessed preoperative laboratory parameters-including hemoglobin, hematocrit, white blood cell count (WBC), platelet count, PLR, NLR, C-reactive protein (CRP), and albumin levels-will be recorded for all included patients. Additionally, the CRP/albumin ratio (CAR) and the aggregate index of systemic inflammation (AISI = platelet × neutrophil × monocyte / lymphocyte) will be calculated and documented.
Upon arrival in the operating room, standard monitoring-including electrocardiography (ECG), noninvasive blood pressure, peripheral oxygen saturation (SpO₂), and body temperature-will be applied. Following monitoring and premedication with intravenous midazolam (0.02 mg/kg), spinal anesthesia will be performed. Under sterile conditions in the sitting position, a 25-gauge spinal needle will be inserted at the L3-L4 interspace. After confirmation of clear cerebrospinal fluid flow, 15 mg of 0.5% hyperbaric bupivacaine will be injected. Patients will then be placed in the supine position, and sensory block level (pinprick test) and motor block (Bromage score) will be assessed. Surgery will be initiated in patients achieving a sensory block at or above the T12 level and a Bromage score of 2. Hemodynamic parameters (heart rate, systolic, diastolic, and mean arterial pressure), body temperature, and SpO₂ values will be recorded at 20-minute intervals intraoperatively.
In our clinic, there is no standardized anesthesia or postoperative analgesia protocol; the choice is based on the surgical site, type of surgery, and clinician experience. Following total knee arthroplasty, ultrasound-guided peripheral nerve blocks may be used for postoperative analgesia according to anesthesiologist preference. The combination of adductor canal block and anterior femoral cutaneous nerve block is commonly preferred. At the end of surgery, while the patient is in the supine position, ultrasound-guided adductor canal and AFCN blocks will be performed. For the adductor canal block, 15 mL of 0.25% bupivacaine will be injected around the femoral artery beneath the sartorius muscle at the mid-thigh level. Subsequently, the AFCN block will be completed by injecting 10 mL of 0.25% bupivacaine superficial to the sartorius muscle at the same level. This combination provides effective analgesia for the anterior and medial aspects of the knee while preserving quadriceps muscle strength and allowing early mobilization.
All patients will receive 1 g of intravenous paracetamol as part of standard postoperative analgesia prophylaxis 20 minutes before the end of surgery. At the end of surgery, patient-controlled analgesia (PCA) with tramadol will be prepared using a 15 mg bolus dose and a 20-minute lockout interval and initiated in the post-anesthesia care unit (PACU). Surgery duration, anesthesia duration, and tourniquet time will be recorded.
Postoperatively, patients will be monitored in the PACU. Sensory block level, hemodynamic parameters, SpO₂ values, and pain scores at rest and during movement will be recorded at 0, 15, and 30 minutes in the PACU, and at 2, 4, 8, 12, and 24 hours on the ward. Nausea and vomiting, sedation level, and quadriceps muscle strength will also be documented. Pain intensity will be assessed using the 10-point Numeric Rating Scale (NRS; 0 = no pain, 10 = worst imaginable pain). Nausea and vomiting severity will be evaluated using a 5-point scale. Patients with an Aldrete score ≥9 and postoperative NRS <4 will be transferred to the ward.
Quadriceps muscle strength will be evaluated as follows: normal strength (score 0), mild weakness (score 1), and severe weakness (score 2). Scores of 1 and 2 will be considered quadriceps weakness.
Postoperative analgesia with tramadol PCA will be continued on the ward. Patients with an NRS score ≥4 will receive 50 mg intravenous dexketoprofen as rescue analgesia. Nausea and vomiting will be treated with intravenous ondansetron and dexamethasone as needed.
Total tramadol consumption, number of PCA demands, time to first rescue analgesic requirement, additional antiemetic use, and block-related complications will be recorded. Laboratory parameters will be recorded at postoperative 12 and 24 hours. Patients will be divided into two subgroups based on receipt of peripheral nerve blocks. Surgical site infection will be evaluated on postoperative days 15 and 30.
This study will document procedures routinely performed in clinical practice and will not impose any additional cost on patients or the institution.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients who peripheral nerve block applied | – | –patients who adductor canal block and anterior femoral cutaneous nerve block applied |
| patients without peripheral nerve block | – | –patients who do not receive adductor canal block and anterior femoral cutaneous nerve block |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18 years and older, scheduled for elective unilateral total knee arthroplasty under spinal anesthesia (SA), classified as American Society of Anesthesiologists (ASA) physical status I-III, and who provided written informed consent after being informed one day before surgery on the ward, will be included.
Key inclusion criteria (5 listed)
- • Patients scheduled for elective unilateral total knee arthroplasty under spinal anesthesia
Key exclusion criteria (11 listed)
- Revision or bilateral surgery
- General anesthesia or conversion to general anesthesia due to failed block
- BMI ≥40 kg/m²
- ASA physical status >III
- Local infection, hematoma, previous surgery, or deformity at the block site
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
assessment of post operative inflammatuar markes
Time frame: it will be recorded at 0, 15, and 30 minutes in the PACU, and at 2, 4, 8, 12, and 24 hours on the ward.
The primary objective of this observational study is to evaluate the effect of adding an anterior femoral cutaneous nerve block to the adductor canal block on the inflammatory response, as assessed by biomarkers such as NLR, PLR, AISI, and CAR, in patients undergoing total knee arthroplasty.
1 secondary outcome
postoperative opioid consumption, wound healing
Time frame: it will be recorded at 0, 15, and 30 minutes in the PACU, and at 2, 4, 8, 12, and 24 hours on the ward.
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 7 Apr 2026.
- BackgroundRazzaz M.; Youssif G.; Wahba S.; Mohamed S.; Mohamed A. Analgesic efficacy of ultrasound guided anterior femoral cutaneous nerve block (AFCNB) plus femoral triangle block (FTB) vs. adductor canal block (ACB) in total knee arthroplasty, Anaesthesia, Pain & Intensive Care, 2025
- Results publication: PubMed 37668689Domagalska M, Ciftsi B, Janusz P, Reysner T, Kolasinski J, Wieczorowska-Tobis K, Kowalski G. The neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR) levels following erector spinae plane block (ESPB) in posterior lumbar decompression: a randomized, controlled trial. Eur Spine J. 2023 Dec;32(12):4192-4199. doi: 10.1007/s00586-023-07913-z. Epub 2023 Sep 5.
- Results publication: PubMed 38002702Domagalska M, Reysner T, Kowalski G, Daroszewski P, Mularski A, Wieczorowska-Tobis K. Pain Management, Functional Recovery, and Stress Response Expressed by NLR and PLR after the iPACK Block Combined with Adductor Canal Block for Total Knee Arthroplasty-A Prospective, Randomised, Double-Blinded Clinical Trial. J Clin Med. 2023 Nov 14;12(22):7088. doi: 10.3390/jcm12227088.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
oznur demiroluk, as prof study director
fatih sultan mehmet traing and research hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Total Knee Anthroplasty, run by Fatih Sultan Mehmet Training 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 5 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 7 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?
assessment of post operative inflammatuar markes (time frame: it will be recorded at 0, 15, and 30 minutes in the PACU, and at 2, 4, 8, 12, and 24 hours on the ward.). 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 NCT07367009, which also lists 3 linked publications.
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 7 Apr 2026.