Dynamic Multimodal Monitoring for Ultrasound Guided Peripheral Nerve Blockade

Not Applicable

• Conditions: Orthopedic Surgery
• Interventions: Procedure: Measurement with a gauge; Procedure: Manual measurement

• Registration Number: NCT02737137
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

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

Detailed 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

Study Timeline

• Status Verified: 2016-01
• Study Start: 2016-01
• Study First Submitted: 2016-03-01
• Study First Submitted QC: 2016-04-12
• Last Update Submitted: 2016-04-12
• Study First Posted: 2016-04-13
• Last Update Posted: 2016-04-13
• Primary Completion: 2017-01
• Study Completion: 2017-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Adult patient
• Orthopedic surgery

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Measurement by a pressure gauge	Measurement with a gauge	Monitoring by ultrasound, Neurostimulation and measurement with a gauge of the injection pressure of the local anesthetic : Group 2
Manual measurement by the anesthetist	Manual measurement	Monitoring by ultrasound, Neurostimulation and Measurement Manual of the injection pressure of the local anesthetic : Group 1

Primary Outcome Measures

Name	Time	Method
Manual measurement	Intraoperative	Manual measurement of the pressure of injection of the local anesthetic during surgery for patients in Group 1

Secondary Outcome Measures

Name	Time	Method
Measured by a pressure gauge	Intraoperative	Measured by a pressure gauge of the pressure of injection of the local anesthetic during surgery for patients in Group 2

Trial Locations

Locations (1)

CHOQUET; 🇫🇷 France, Montpellier, France