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Dynamic Multimodal Monitoring for Ultrasound Guided Peripheral Nerve Blockade

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ClinicalTrials.gov Identifier: NCT02737137
Recruitment Status : Unknown
Verified January 2016 by University Hospital, Montpellier.
Recruitment status was:  Recruiting
First Posted : April 13, 2016
Last Update Posted : April 13, 2016
Sponsor:
Information provided by (Responsible Party):
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


Condition or disease Intervention/treatment Phase
Orthopedic Surgery Procedure: Manual measurement Procedure: Measurement with a gauge Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Supportive Care
Official Title: 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
Study Start Date : January 2016
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
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 Name: 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 Name: Measured by a pressure gauge




Primary Outcome Measures :
  1. Manual measurement [ Time Frame: Intraoperative ]
    Manual measurement of the pressure of injection of the local anesthetic during surgery for patients in Group 1


Secondary Outcome Measures :
  1. Measured by a pressure gauge [ Time Frame: Intraoperative ]
    Measured by a pressure gauge of the pressure of injection of the local anesthetic during surgery for patients in Group 2



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patient
  • Orthopedic surgery

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02737137


Contacts
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Contact: Olivier CHOQUET, MD 4 67 33 82 56 ext +33 o-choquet@chu-montpellier.fr

Locations
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France
CHOQUET Recruiting
France, Montpellier, France, 34295
Contact: Olivier CHOQUET         
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Principal Investigator: Olivier CHOQUET University Hospital, Montpellier

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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT02737137     History of Changes
Other Study ID Numbers: 9654
2015-A01850-49 ( Registry Identifier: ID-RCB )
First Posted: April 13, 2016    Key Record Dates
Last Update Posted: April 13, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Anesthetics
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents