Knee OsteoarthritisNCT05566561
Para-sartorial Compartment Block in Knee Surgery
A study testing Postoperative analgesia management in people with Knee Osteoarthritis and Knee Injuries, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
Selective blockade of the saphenous nerve branches is among the regional anesthesia techniques in knee surgery. In this block, analgesia is provided without motor block and is an essential advantage in terms of early mobilization in the postoperative period. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Knee Osteoarthritis, Knee Injuries, Knee Disease
- What is being tested?
- Postoperative analgesia management
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Oct 2022to 16 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with ASA classification I-III,
- Aged 18-75 years
- Who will be scheduled for knee surgery under spinal anesthesia.
Who cannot join
- Patients who have a history of bleeding diathesis,
- Take anticoagulant therapy,
- History of chronic pain before surgery,
- Multiple trauma,
- Who cannot assess their pain,
- Who have been operated under spinal anesthesia,
- Who have an infection in the area and do not accept the procedure
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University Hospital
Istanbul, Bagcilar, 34070
About this study
Official title: Postoperative Analgesic Efficacy of Ultrasound-guided Para-sartorial Compartment Block in Knee Surgery: A Randomized Study
Selective blockade of the saphenous nerve branches is among the regional anesthesia techniques in knee surgery. In this block, analgesia is provided without motor block and is an essential advantage in terms of early mobilization in the postoperative period. Blockage of motor branches causes a delay in mobilization and increases the risk of falling. The vastus medialis and its medical femoral cutaneous branch are rich in the femoral triangle. Effective postoperative analgesia is provided by a femoral triangle (triangle) blockade. The intermediate femoral cutaneous nerve courses over the sartorius muscle. Anatomically, the femoral triangle follows a separate path. When the femoral triangle and the blockade of the intermediate femoral cutaneous nerve are combined, it is called PSKB block. Parasartorial compartment block (PSKB); is based on the blockade of the branches of the saphenous nerve, the two largest sensory nerves from the femoral nerve to the knee, and is predicted to provide effective postoperative analgesia in knee arthroplasty.
Read the detailed description
Selective blockade of the saphenous nerve branches is among the regional anesthesia techniques in knee surgery. In this block, analgesia is provided without motor block and is an essential advantage in terms of early mobilization in the postoperative period. Blockage of motor branches causes a delay in mobilization and increases the risk of falling. The vastus medialis and its medical femoral cutaneous branch are rich in the femoral triangle. Effective postoperative analgesia is provided by a femoral triangle (triangle) blockade. The intermediate femoral cutaneous nerve courses over the sartorius muscle. Anatomically, the femoral triangle follows a separate path. When the femoral triangle and the blockade of the intermediate femoral cutaneous nerve are combined, it is called PSKB block. Parasartorial compartment block (PSKB); is based on the blockade of the branches of the saphenous nerve, the two largest sensory nerves from the femoral nerve to the knee, and is predicted to provide adequate postoperative analgesia in knee arthroplasty.
Pascarella et al. applied PSKB to a 58-year-old patient who underwent knee surgery under spinal anesthesia and had pain in the postoperative period and reported that the patient with a visual pain score of 9 decreased to 2 after the block.
This study, it is aimed to evaluate the effectiveness of para-sartorial canal block for postoperative analgesia management in patients undergoing knee surgery. Our primary aim is to compare postoperative opioid consumption, and our secondary aim is to evaluate postoperative pain scores (Numerical rating scale-NRS), the presence of motor blockade, first postoperative mobilization time, and side effects (allergic reaction, nausea, vomiting, etc.) associated with opioid use.
- Conditions
- Knee Osteoarthritis, Knee Injuries, Knee Disease, Knee Arthritis
- Being tested
- Postoperative analgesia management
- Keywords
- Knee Surgery, Postoperative pain management, Postoperative Analgesia, Parasartorial compartment block
- Medical subject headings
- Osteoarthritis, Knee, Knee Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postoperative analgesia managementDrug
Intravenous 0.5 mg/kg tramadol and 400 mg ibuprofen will be administered to all patients 30 minutes before the end of the surgical procedure. In the postoperative period, patients will be administered ibuprofen iv 400 mg 3x1. Postoperative patient evaluation will be performed by another pain nurse who is unaware of the procedure. Patients in all groups will be attached to IV PCA containing 10 mcg/ml fentanyl, 10 mcg bolus without infusion dose, and 10 min lock time protocol. If the NRS score is ≥ 4, 0.5 mg kg-1 iv meperidine will be administered as a rescue analgesic.
| Study group | Role | What they receive |
|---|---|---|
| Group PSCB = Parasartorial compartment block group | Active comparator | After placing the linear ultrasound probe in the middle of the anterior superior line to the patella and spina drug, the probe will be advanced cephalad to visualize the intermediate femoral cutaneous nerve over the satrorious. Then the block will be applied. Three injections will be made with a single needle entry in the same imaging. The procedure will be completed by applying the first injection to the femoral triangle (10 ml of local anesthetic solution), the second injection to the subsartorial region (10 ml of local anesthetic solution) lateral to the femoral artery, and the third injection to the suprasartorial region (10 ml of local anesthetic solution) (total 30 ml of 0.25% solution). concentration bupivacaine). The block location will be confirmed by injecting 2 ml of saline in every three injections. Receives: Drug: Postoperative analgesia management |
| Group C = Control group | Active comparator | Wound infiltration will be applied by the surgical team Receives: Drug: Postoperative analgesia management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scores (Numerical Rating Scale-NRS)
Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)
Measured: Changes from baseline pain scores at postoperative 8th hour
Secondary outcomes (2)
Rescue analgesia (Opioid-tramadol consumption)
The tramadol consumption as rescue analgesia will be evaluated
Measured: Changes from baseline opioid consumption at postoperative 1, 2, 4, 8, 16 and 24 hours.
Adverse events will be recorded
Adverse events; nausea, vomiting, itching
Measured: Postoperative 24 hours period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study start19 Oct 2022
- Primary completion10 Aug 2025
- Study completion16 Sep 2025
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 Knee OsteoarthritisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There are two models for this study. Parasartorial compartment block (PSCB) group, and control group.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bahadir Ciftci, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05566561
- Sponsor's protocol ID
- Medipol Hospital 31
- Status last verified
- Nov 2025
- First submitted
- 30 Sep 2022
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators will not share IPD
Publications
Pascarella G, Costa F, Del Buono R, Strumia A, Cataldo R, Agro F, Carassiti M. The para-sartorial compartments (PASC) block: a new approach to the femoral triangle block for complete analgesia of the anterior knee. Anaesth Rep. 2022 May 5;10(1):e12165. doi: 10.1002/anr3.12165. eCollection 2022 Jan-Jun. No abstract available.
PubMed 35547556Martin R, Kirkham KR, Ngo THN, Gonvers E, Lambert J, Albrecht E. Combination of femoral triangle block and infiltration between the popliteal artery and the capsule of the posterior knee (iPACK) versus local infiltration analgesia for analgesia after anterior cruciate ligament reconstruction: a randomized controlled triple-blinded trial. Reg Anesth Pain Med. 2021 Sep;46(9):763-768. doi: 10.1136/rapm-2021-102631. Epub 2021 May 26.
PubMed 34039734Stebler K, Martin R, Kirkham KR, Lambert J, De Sede A, Albrecht E. Adductor canal block versus local infiltration analgesia for postoperative pain after anterior cruciate ligament reconstruction: a single centre randomised controlled triple-blinded trial. Br J Anaesth. 2019 Aug;123(2):e343-e349. doi: 10.1016/j.bja.2019.04.053. Epub 2019 May 24.
PubMed 31130273
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Analgesic Efficacy of Ultrasound-guided Para-sartorial Compartment Block in Knee Surgery: A Randomized Study
- ClinicalTrials.gov ID
- NCT05566561
- Acronym / sponsor ID
- Medipol Hospital 31
- Conditions
- Knee Osteoarthritis, Knee Injuries, Knee Disease, Knee Arthritis
- Keywords
- Knee Surgery, Postoperative pain management, Postoperative Analgesia, Parasartorial compartment block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 19 Oct 2022 (actual)
- Primary completion
- 10 Aug 2025 (actual)
- Study completion
- 16 Sep 2025 (actual)
- First posted
- 4 Oct 2022 (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.
Selective blockade of the saphenous nerve branches is among the regional anesthesia techniques in knee surgery. In this block, analgesia is provided without motor block and is an essential advantage in terms of early mobilization in the postoperative period. Blockage of motor branches causes a delay in mobilization and increases the risk of falling. The vastus medialis and its medical femoral cutaneous branch are rich in the femoral triangle. Effective postoperative analgesia is provided by a femoral triangle (triangle) blockade. The intermediate femoral cutaneous nerve courses over the sartorius muscle. Anatomically, the femoral triangle follows a separate path. When the femoral triangle and the blockade of the intermediate femoral cutaneous nerve are combined, it is called PSKB block. Parasartorial compartment block (PSKB); is based on the blockade of the branches of the saphenous nerve, the two largest sensory nerves from the femoral nerve to the knee, and is predicted to provide effective postoperative analgesia in knee arthroplasty.
Detailed description
Selective blockade of the saphenous nerve branches is among the regional anesthesia techniques in knee surgery. In this block, analgesia is provided without motor block and is an essential advantage in terms of early mobilization in the postoperative period. Blockage of motor branches causes a delay in mobilization and increases the risk of falling. The vastus medialis and its medical femoral cutaneous branch are rich in the femoral triangle. Effective postoperative analgesia is provided by a femoral triangle (triangle) blockade. The intermediate femoral cutaneous nerve courses over the sartorius muscle. Anatomically, the femoral triangle follows a separate path. When the femoral triangle and the blockade of the intermediate femoral cutaneous nerve are combined, it is called PSKB block. Parasartorial compartment block (PSKB); is based on the blockade of the branches of the saphenous nerve, the two largest sensory nerves from the femoral nerve to the knee, and is predicted to provide adequate postoperative analgesia in knee arthroplasty.
Pascarella et al. applied PSKB to a 58-year-old patient who underwent knee surgery under spinal anesthesia and had pain in the postoperative period and reported that the patient with a visual pain score of 9 decreased to 2 after the block.
This study, it is aimed to evaluate the effectiveness of para-sartorial canal block for postoperative analgesia management in patients undergoing knee surgery. Our primary aim is to compare postoperative opioid consumption, and our secondary aim is to evaluate postoperative pain scores (Numerical rating scale-NRS), the presence of motor blockade, first postoperative mobilization time, and side effects (allergic reaction, nausea, vomiting, etc.) associated with opioid use.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- There are two models for this study. Parasartorial compartment block (PSCB) group, and control group.
| Arm | Type | Receives |
|---|---|---|
| Group PSCB = Parasartorial compartment block group | Active comparator | Drug: Postoperative analgesia managementAfter placing the linear ultrasound probe in the middle of the anterior superior line to the patella and spina drug, the probe will be advanced cephalad to visualize the intermediate femoral cutaneous nerve over the satrorious. Then the block will be applied. Three injections will be made with a single needle entry in the same imaging. The procedure will be completed by applying the first injection to the femoral triangle (10 ml of local anesthetic solution), the second injection to the subsartorial region (10 ml of local anesthetic solution) lateral to the femoral artery, and the third injection to the suprasartorial region (10 ml of local anesthetic solution) (total 30 ml of 0.25% solution). concentration bupivacaine). The block location will be confirmed by injecting 2 ml of saline in every three injections. |
| Group C = Control group | Active comparator | Drug: Postoperative analgesia managementWound infiltration will be applied by the surgical team |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with ASA classification I-III,
- Aged 18-75 years
- Who will be scheduled for knee surgery under spinal anesthesia.
Key exclusion criteria (7 listed)
- Patients who have a history of bleeding diathesis,
- Take anticoagulant therapy,
- History of chronic pain before surgery,
- Multiple trauma,
- Who cannot assess their pain,
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 |
|---|---|---|
| Postoperative analgesia managementIntravenous 0.5 mg/kg tramadol and 400 mg ibuprofen will be administered to all patients 30 minutes before the end of the surgical procedure. In the postoperative period, patients will be administered ibuprofen iv 400 mg 3x1. Postoperative patient evaluation will be performed by another pain nurse who is unaware of the procedure. Patients in all groups will be attached to IV PCA containing 10 mcg/ml fentanyl, 10 mcg bolus without infusion dose, and 10 min lock time protocol. If the NRS score is ≥ 4, 0.5 mg kg-1 iv meperidine will be administered as a rescue analgesic. | Drug | Group C = Control group, Group PSCB = Parasartorial compartment block group |
Primary outcome
Pain scores (Numerical Rating Scale-NRS)
Time frame: Changes from baseline pain scores at postoperative 8th hour
Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)
2 secondary outcomes
Rescue analgesia (Opioid-tramadol consumption)
Time frame: Changes from baseline opioid consumption at postoperative 1, 2, 4, 8, 16 and 24 hours.
Adverse events will be recorded
Time frame: Postoperative 24 hours period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Background: PubMed 35547556Pascarella G, Costa F, Del Buono R, Strumia A, Cataldo R, Agro F, Carassiti M. The para-sartorial compartments (PASC) block: a new approach to the femoral triangle block for complete analgesia of the anterior knee. Anaesth Rep. 2022 May 5;10(1):e12165. doi: 10.1002/anr3.12165. eCollection 2022 Jan-Jun. No abstract available.
- Background: PubMed 34039734Martin R, Kirkham KR, Ngo THN, Gonvers E, Lambert J, Albrecht E. Combination of femoral triangle block and infiltration between the popliteal artery and the capsule of the posterior knee (iPACK) versus local infiltration analgesia for analgesia after anterior cruciate ligament reconstruction: a randomized controlled triple-blinded trial. Reg Anesth Pain Med. 2021 Sep;46(9):763-768. doi: 10.1136/rapm-2021-102631. Epub 2021 May 26.
- Background: PubMed 31130273Stebler K, Martin R, Kirkham KR, Lambert J, De Sede A, Albrecht E. Adductor canal block versus local infiltration analgesia for postoperative pain after anterior cruciate ligament reconstruction: a single centre randomised controlled triple-blinded trial. Br J Anaesth. 2019 Aug;123(2):e343-e349. doi: 10.1016/j.bja.2019.04.053. Epub 2019 May 24.
- Individual participant dataSharing planned: No. The investigators will not share IPD
Related trials for Knee Osteoarthritis
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Active, not recruiting
SakuraBead Used as Resorbable Embolic for Genicular Artery Embolization
Osteo Arthritis Knee, Joint Diseases
RecruitingPhase 2
Genicular Artery Embolization for Reducing Pain in Medically Refractory Symptomatic Knee Osteoarthritis
Knee Osteoarthritis, Knee Osteoarthritis (Knee OA)
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
Recruiting
The Effect of Different Exercise Training Programs on Muscle Oxygenation in Individuals With Knee Osteoarthritis
Osteoarthritis of Knee
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.
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 Postoperative analgesia management in people with Knee Osteoarthritis and Knee Injuries, run by Medipol University 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 3 inclusion and 7 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: finished, as of the sponsor's last update on 2 Dec 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pain scores (Numerical Rating Scale-NRS) (time frame: Changes from baseline pain scores at postoperative 8th hour). 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 NCT05566561, 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 2 Dec 2025.