Ultrasound-guided Genicular Nerve Block for Total Knee Arthroplasty.

Pain Clinical Trial

— PGENECA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04681547
• Other study ID #: HCB/2019/1148
• Secondary ID: 2019-005010-19
• Status: Completed
• Phase: Phase 4
• Start date: December 15, 2020
• Est. completion date: April 30, 2021

Study information

• Verified date: May 2021
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 30, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Subjects scheduled for primary elective total knee arthroplasty

• American Society of Anesthesiologists Physical Status I-III

• BMI 18-40 kg/m2

Exclusion Criteria:

• Inability to cooperate with protocol

• Allergy to any medication of protocol

• Contraindication to peripheral nerve block (e.g. local or systemic infection, neurologic deficit or disorder, previous trauma or surgery to ipsilateral knee, etc.)

• Revision or prothesis replacement knee surgery

• Chronic opioid consumption (daily morphine equivalent of >30 mg for at least four weeks prior to surgery)

• Bleeding diathesis or non-pharmacological coagulopathy

Related Conditions & MeSH terms

• Pain

Intervention

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.
• 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%.

Locations

Country	Name	City	State
Spain	Hospital Clínic de Barcelona	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Secondary	Opioid consumption in the postoperative period	Opioid consumption in the postoperative period in oral morphine equivalents	until 24 hours
Secondary	Knee mobility range	Minimal and maximal mobility range [degrees]	24 hours
Secondary	Quality of sleep	Quality of sleep of the first night using the quality of sleep visual analogue scale [0-100 mm]	24 hours