Ultrasound-guided Genicular Nerve Block for Total Knee Arthroplasty. (PGENECA)

Hospital Clinic of Barcelona

Status and phase: Completed; Phase 4

Conditions: Pain

Treatments: Procedure: Local Infiltration Analgesia; Procedure: Genicular nerve Block

Study type: Interventional

Funder types: Other

Identifiers

NCT04681547

2019-005010-19 (EudraCT Number)

HCB/2019/1148

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Genicular nerve block

Experimental group

Description:

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.

Treatment:

Procedure: Genicular nerve Block

Local infiltration Analgesia

Active Comparator group

Description:

Administration of ropivacaine 0.2% 150 ml will be performed.

Treatment:

Procedure: Local Infiltration Analgesia