Ultrasound-guided Genicular Nerve Block for Total Knee Arthroplasty.

Phase 4

Completed

• Conditions: Pain
• Interventions: Procedure: Genicular nerve Block; Procedure: Local Infiltration Analgesia

• Registration Number: NCT04681547
• Lead Sponsor: Hospital Clinic of Barcelona

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.

Study Timeline

• Study Start: 2020-12-15
• Study First Submitted: 2020-12-15
• Study First Submitted QC: 2020-12-18
• Study First Posted: 2020-12-23
• Primary Completion: 2021-04-30
• Study Completion: 2021-04-30
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-31
• Last Update Posted: 2021-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Genicular nerve block	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.
Local infiltration Analgesia	Local Infiltration Analgesia	Administration of ropivacaine 0.2% 150 ml will be performed.

Primary Outcome Measures

Name	Time	Method
NRS at PACU	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.
NRS at 12 hours after surgery	12 hours	Pain will be assessed by NRS \[Numerical Rating Scale, 0-11\] by a ward nurse, blind for intraoperative analgesic treatment.
NRS at 24 hours after surgery	24 hours	Pain will be assessed by NRS \[Numerical Rating Scale, 0-11\] by a ward nurse, blind for intraoperative analgesic treatment.
NRS after physiotherapy	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 Outcome Measures

Name	Time	Method
Opioid consumption in the postoperative period	until 24 hours	Opioid consumption in the postoperative period in oral morphine equivalents
Quality of sleep	24 hours	Quality of sleep of the first night using the quality of sleep visual analogue scale \[0-100 mm\]
Knee mobility range	24 hours	Minimal and maximal mobility range \[degrees\]

Trial Locations

Locations (1)

Hospital Clínic de Barcelona; 🇪🇸 Barcelona, Spain