The hypothesis is to demonstrate the analgesic non-inferiority of the ultrasound-guided geniculate nerve block when compared to the local infiltration analgesia (LIA). It is expected to maintain the quality of analgesia with a selective blockade of the nerves responsible for the sensitive innervation of the knee, reducing the total dose of local anesthetic and adrenaline very markedly.
The main objective is to demonstrate that the ultrasound-guided geniculate nerve block provides not-inferior analgesia to LIA in patients undergoing primary total knee arthroplasty (TKA) in the first 24 hours postoperatively, and during the first mobilization using the numerical evaluation of the pain (NRS). The secondary objectives are to demonstrate that the consumption of opioids and the range of joint mobility are not inferior in those patients who receive geniculate nerve blocks compared to those who receive LIA.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
60
After the administration of spinal anesthesia, the anatomical structures of the proximal and distal region of the knee will be explored through an M- ultrasound machine Turbo® with a high-frequency 6-13 MHz linear probe. The ultrasound transducer will be placed in a coronal orientation to the axis of the knee in the corresponding area to be blocked according to anatomical landmarks of superior medial genicular nerve (SMGN), inferior medial genicular nerve block (IMGN), superior lateral genicular nerve (SLGN), inferior lateral genicular nerve (ILGN), and recurrent genicular nerve (RGN). It should be noted that the visualization of the genicular arteries in the femoral epicondyles and in the area of the tibial plateau, represents an accurate guide to where the sensory afferents are, however; its display is not constant. 4 ml of 0.2% ropivacaine will be administered, with adrenaline 1: 100 000 in each of the five nerves.
100 ml of ropivacaine 0.2% with 1 mg of epinephrine during the period of intraoperative ischemia and, before the closure of the surgical wound, 50 ml of ropivacaine 0.2%.
Hospital Clínic de Barcelona
Barcelona, Spain
NRS at PACU
NRS \[Numerical Rating Scale, 0-11\] at PACU \[post-anaesthesia care unit\] after spinal block reversal, evaluated as active contralateral knee genuflection at 90 degrees.
Time frame: 1 hour after surgery
NRS at 12 hours after surgery
Pain will be assessed by NRS \[Numerical Rating Scale, 0-11\] by a ward nurse, blind for intraoperative analgesic treatment.
Time frame: 12 hours
NRS at 24 hours after surgery
Pain will be assessed by NRS \[Numerical Rating Scale, 0-11\] by a ward nurse, blind for intraoperative analgesic treatment.
Time frame: 24 hours
NRS after physiotherapy
It corresponds to day 1 after the surgical intervention and will be carried out in the hospitalization room by a physiotherapist. The NRS \[Numerical Rating Scale, 0-11\] will be recorded during the first examination and mobilization
Time frame: 24 hours
Opioid consumption in the postoperative period
Opioid consumption in the postoperative period in oral morphine equivalents
Time frame: until 24 hours
Knee mobility range
Minimal and maximal mobility range \[degrees\]
Time frame: 24 hours
Quality of sleep
Quality of sleep of the first night using the quality of sleep visual analogue scale \[0-100 mm\]
Time frame: 24 hours
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