Ultrasound-guided Genicular Nerve Block for Total Knee Arthroplasty.

NCT ID: NCT04681547

Last Updated: 2021-06-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-15
• Study Completion Date: 2021-04-30

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Genicular nerve block

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.

Group Type: EXPERIMENTAL

Genicular nerve Block

Intervention Type: 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

Administration of ropivacaine 0.2% 150 ml will be performed.

Group Type: ACTIVE_COMPARATOR

Local Infiltration Analgesia

Intervention Type: 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%.

Interventions

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.

Intervention Type: 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%.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Clinic of Barcelona

OTHER

Sponsor Role: lead

Responsible Party

TOMAS MIGUEL CUÑAT LOPEZ

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tomás López, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinic of Barcelona

Xavier Sala-Blanch, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinic of Barcelona

Locations

Hospital Clínic de Barcelona

Barcelona, , Spain

Countries

Spain

Other Identifiers

2019-005010-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

HCB/2019/1148

Identifier Type: -

Identifier Source: org_study_id