Dynamic Multimodal Monitoring for Ultrasound Guided Peripheral Nerve Blockade

Monitoring Combining Neurostimulation and Ultrasound Guidance During the Realization of a Peripheral Nerve Block: Value of Objective Measurement of the Pressure of Injection of the Local Anesthetic

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

Study Overview

• Status: Unknown
• Conditions: Orthopedic Surgery
• Intervention / Treatment: Procedure: Manual measurement; Procedure: Measurement with a gauge

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 Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier
    • France, Montpellier, France, 34295
      • Recruiting
      • CHOQUET
      • Contact: Olivier CHOQUET

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult patient
• Orthopedic surgery

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Manual measurement by the anesthetist; Monitoring by ultrasound, Neurostimulation and Measurement Manual of the injection pressure of the local anesthetic : Group 1	Procedure: Manual measurement; Monitoring by ultrasound, Neurostimulation and Measurement Manual of the injection pressure of the local anesthetic; Other Names: Manual measurement by the anesthetist
Experimental: Measurement by a pressure gauge; Monitoring by ultrasound, Neurostimulation and measurement with a gauge of the injection pressure of the local anesthetic : Group 2	Procedure: Measurement with a gauge; Monitoring by ultrasound, Neurostimulation and measurement with a gauge of the pressure of injection of the local anesthetic; Other Names: Measured by a pressure gauge

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Manual measurement	Manual measurement of the pressure of injection of the local anesthetic during surgery for patients in Group 1	Intraoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measured by a pressure gauge	Measured by a pressure gauge of the pressure of injection of the local anesthetic during surgery for patients in Group 2	Intraoperative

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Olivier CHOQUET, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Anticipated): January 1, 2017
• Study Completion (Anticipated): January 1, 2017

Study Registration Dates

• First Submitted: March 1, 2016
• First Submitted That Met QC Criteria: April 12, 2016
• First Posted (Estimate): April 13, 2016

Study Record Updates

• Last Update Posted (Estimate): April 13, 2016
• Last Update Submitted That Met QC Criteria: April 12, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 9654; 2015-A01850-49 (Registry Identifier: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED