Para-sartorial Compartment Block in Knee Surgery

Knee Osteoarthritis Clinical Trial

Official title:

Postoperative Analgesic Efficacy of Ultrasound-guided Para-sartorial Compartment Block in Knee Surgery: A Randomized Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05566561
• Other study ID #: Medipol Hospital 31
• Status: Recruiting
• Phase: N/A
• Start date: October 19, 2022
• Est. completion date: August 16, 2024

Study information

• Verified date: June 2024
• Source: Medipol University
• Contact: Bahadir Ciftci, Assoc prof, MD
• Phone: +905343736865
• Email: bciftci[@]medipol.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 16, 2024
• Est. primary completion date: August 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients with ASA classification I-III,

• Aged 18-75 years

• Who will be scheduled for knee surgery under spinal anesthesia.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Knee Arthritis
• Knee Disease
• Knee Injuries
• Knee Osteoarthritis

Intervention

Drug:
• Postoperative analgesia management
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.

Locations

Country	Name	City	State
Turkey	Istanbul Medipol University Hospital	Istanbul	Bagcilar

Sponsors (1)

Lead Sponsor	Collaborator
Medipol University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Martin 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. — View Citation

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. — View Citation

Stebler 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid consumption	The fentanyl consumption on PCA device will be evaluated	Changes from baseline opioid consumption at postoperative 1, 2, 4, 8, 16 and 24 hours.
Secondary	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)	Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16 and 24 hours
Secondary	Adverse events will be recorded	Adverse events; nausea, vomiting, itching	Postoperative 24 hours period