Dynamic Multimodal Monitoring for Ultrasound Guided Peripheral Nerve Blockade

University Hospital Center (CHU)

Status: Unknown

Conditions: Orthopedic Surgery

Treatments: Procedure: Measurement with a gauge; Procedure: Manual measurement

Study type: Interventional

Funder types: Other

Identifiers

NCT02737137

2015-A01850-49 (Registry Identifier)

9654

Details and patient eligibility

About

In clinical practice, local anesthetic injection pressure monitoring is performed manually or by a pressure transducer according to the availability of the equipment or preferences of clinicians. To date, no comparative study has measured the advantages of this measure during PNB.

The aim of this study is to evaluate injection pressure monitoring in order to reduce the risk of intraneural injection during peripheral nerve blocks

Full description

Current recommendations for peripheral nerve block (PNB) procedure advocate combining ultrasound guidance and nerve stimulation.

Despite these different means of identification, nerves contacts and intraneural injection are frequent. Even rare, nerve damage may occur.

The nerve damage may be related to direct trauma with the needle or inadvertent intra-neural injection. High injection pressure of local anesthetic (AL) is an indicator that further characterize the location of the needle in terms of tissue density. In clinical practice, local anesthetic injection pressure monitoring is performed manually or by a pressure transducer according to the availability of the equipment or preferences of clinicians. To date, no comparative study has measured the advantages of this measure during PNB.

The aim of this study is to evaluate injection pressure monitoring in order to reduce the risk of intraneural injection.

Group 1: ultrasound-guided technique PNB "in plane" needle approach, nerve stimulator set to sentinel mode. Manual injection pressure control Group 2: ultrasound-guided PNB, "in plane" approach, Nerve stimulator set to detection mode. Electronic Injection Pressure controlled with low flow local anesthetic during procedure

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patient
• Orthopedic surgery

Exclusion criteria

• Allergy to local anesthetics
• ASA score >III
• Severe neuropathy
• puncture site disease
• parturient or breastfeeding

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Manual measurement by the anesthetist

Other group

Description:

Monitoring by ultrasound, Neurostimulation and Measurement Manual of the injection pressure of the local anesthetic : Group 1

Treatment:

Procedure: Manual measurement

Measurement by a pressure gauge

Experimental group

Description:

Monitoring by ultrasound, Neurostimulation and measurement with a gauge of the injection pressure of the local anesthetic : Group 2

Treatment:

Procedure: Measurement with a gauge