Ultrasound-guided Genicular Nerve Block for Total Knee Arthroplasty.

NCT04681547 | Completed Phase 4

• 2 other identifiers: HCB/2019/11482019-005010-19
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain

Keywords

Pain; Analgesia; LIA; Ultrasound; Genicular Nerve Block

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (3)

• Opioid consumption in the postoperative period

  until 24 hours

• Knee mobility range

  24 hours

• Quality of sleep

  24 hours

Study Arms (2)

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.

Procedure: Genicular nerve Block

Local infiltration Analgesia

ACTIVE COMPARATOR

Administration of ropivacaine 0.2% 150 ml will be performed.

Procedure: Local Infiltration Analgesia

Interventions

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.

Genicular nerve block

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%.

Local infiltration Analgesia

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects scheduled for primary elective total knee arthroplasty
• American Society of Anesthesiologists Physical Status I-III
• BMI 18-40 kg/m2

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (1)

Hospital Clínic de Barcelona

Barcelona, 08036, Spain

Location

MeSH Terms

Conditions

Pain; Agnosia

Condition Hierarchy (Ancestors)

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

Study Officials

• Tomás López, MD

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

• Xavier Sala-Blanch, MD

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 15, 2020
• First Posted: December 23, 2020
• Study Start: December 15, 2020
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: June 2, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)