Para-sartorial Compartment Block in Knee Surgery

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.

Study Overview

• Status: Recruiting
• Conditions: Knee Osteoarthritis; Knee Injuries; Knee Arthritis; Knee Disease
• Intervention / Treatment: Drug: Postoperative analgesia management

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bahadir Ciftci, Assoc Prof, MD; Phone Number: +905343736865; Email: bciftci@medipol.edu.tr
• Study Contact Backup: Name: Yunus Atalay, Assoc prof, MD

Study Locations

• Turkey
  • Bagcilar
    • Istanbul, Bagcilar, Turkey, 34070
      • Recruiting
      • Istanbul Medipol University Hospital
      • Contact: Bahadir Ciftci, MD; Phone Number: +905325034428; Email: bciftci@medipol.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group PSCB = Parasartorial compartment block group; 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.	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.
Active Comparator: Group C = Control group; Wound infiltration will be applied by the surgical team	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Adverse events will be recorded	Adverse events; nausea, vomiting, itching	Postoperative 24 hours period

Collaborators and Investigators

• Sponsor: Medipol University

Publications and helpful links

General 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2022
• Primary Completion (Estimated): May 10, 2024
• Study Completion (Estimated): May 16, 2024

Study Registration Dates

• First Submitted: September 30, 2022
• First Submitted That Met QC Criteria: September 30, 2022
• First Posted (Actual): October 4, 2022

Study Record Updates

• Last Update Posted (Estimated): December 11, 2023
• Last Update Submitted That Met QC Criteria: December 8, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Postoperative Analgesia; Postoperative pain management; Knee Surgery; Parasartorial compartment block
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries
• Other Study ID Numbers: Medipol Hospital 31

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The investigators will not share IPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No