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Completed

NCT Number: NCT04681547

Ultrasound-guided Genicular Nerve Block for Total Knee Arthroplasty.

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.

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Key information

Conditions

Pain Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Clínic de Barcelona

Barcelona, 08036, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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%.

Primary outcomes

  1. NRS at PACU

    Time frame: 1 hour after surgery

    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.

  2. NRS at 12 hours after surgery

    Time frame: 12 hours

    Pain will be assessed by NRS [Numerical Rating Scale, 0-11] by a ward nurse, blind for intraoperative analgesic treatment.

  3. NRS at 24 hours after surgery

    Time frame: 24 hours

    Pain will be assessed by NRS [Numerical Rating Scale, 0-11] by a ward nurse, blind for intraoperative analgesic treatment.

  4. NRS after physiotherapy

    Time frame: 24 hours

    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

Secondary outcomes

  1. Opioid consumption in the postoperative period

    Time frame: until 24 hours

    Opioid consumption in the postoperative period in oral morphine equivalents

  2. Knee mobility range

    Time frame: 24 hours

    Minimal and maximal mobility range [degrees]

  3. Quality of sleep

    Time frame: 24 hours

    Quality of sleep of the first night using the quality of sleep visual analogue scale [0-100 mm]

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Registry information

Official study title

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

Acronym: PGENECA

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 23, 2020
Registry last updated
Jun 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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