NCT04681547

Ultrasound-guided Genicular Nerve Block for Total Knee Arthroplasty.

Ultrasound-guided Genicular Nerve Block: An Analgesic Alternative to LIA for Total Knee Arthroplasty.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Hospital Clinic of Barcelona · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Pain

Interventions

Type	Name	Description
PROCEDURE	Genicular nerve Block	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.
PROCEDURE	Local Infiltration Analgesia	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%.

Timeline

• Start date: 2020-12-15
• Primary completion: 2021-04-30
• Completion: 2021-04-30
• First posted: 2020-12-23
• Last updated: 2021-06-02

Locations

1 site across 1 country: Spain