Clinical trial

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

Name

Medipol Hospital 31

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 effective postoperative analgesia in knee arthroplasty.

Trial arms

Trial start

2022-10-19

Estimated PCD

2024-08-10

Trial end

2024-08-16

Status

Recruiting

Treatment

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.

Arms:

Group C = Control group, Group PSCB = Parasartorial compartment block group

Size

Primary endpoint

Opioid consumption

Changes from baseline opioid consumption at postoperative 1, 2, 4, 8, 16 and 24 hours.

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'There are two models for this study. Parasartorial compartment block (PSCB) group, and control group.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'The patient and the outcomes assessor who performs postoperative pain evaluation will not know the group.', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}

Updated at

2024-06-04

1 organization

1 product

4 indications

Organization

Medipol University

Product

Postoperative analgesia management

Indication

Indication

Indication

Indication