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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-005010-19 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Genicular nerve block | Experimental | An ultrasound-assisted genicular nerve block will be performed. 4 ml of 0.2% ropivacaine will be administered, with adrenaline 1: 100 000 in each of the five nerves. |
|
| Local infiltration Analgesia | Active Comparator | Administration of ropivacaine 0.2% 150 ml will be performed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Genicular nerve Block | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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 | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid consumption in the postoperative period | Opioid consumption in the postoperative period in oral morphine equivalents | until 24 hours |
| Knee mobility range | Minimal and maximal mobility range [degrees] |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tomás López, MD | Hospital Clinic of Barcelona | Principal Investigator |
| Xavier Sala-Blanch, MD | Hospital Clinic of Barcelona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital ClÃnic de Barcelona | Barcelona | 08036 | Spain |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
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| Local Infiltration Analgesia | Procedure | 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%. |
|
| 24 hours |
| Quality of sleep | Quality of sleep of the first night using the quality of sleep visual analogue scale [0-100 mm] | 24 hours |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |