CClinicalTrials.gg
Status unknownNCT02737137Updated Apr 13, 2016

Dynamic Multimodal Monitoring for Ultrasound Guided Peripheral Nerve Blockade

An interventional study of Manual measurement and Measurement with a gauge in Orthopedic Surgery, sponsored by University Hospital, Montpellier. Status unknown at 1 site in France. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2016-04-13.

Sponsored by University Hospital, Montpellier · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Jan 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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

Read the 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

02

Conditions studied

  • Orthopedic Surgery
03

In context

Lead sponsor

University Hospital, Montpellier is the lead sponsor of 1,244 studies on the registry; 225 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Adult patient
  • Orthopedic surgery

Exclusion criteria

Exclusion Criteria:

  • Allergy to local anesthetics
  • ASA score >III
  • Severe neuropathy
  • puncture site disease
  • parturient or breastfeeding
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
120 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • ProcedureManual measurement

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

    Also known as: Manual measurement by the anesthetist

  • ProcedureMeasurement with a gauge

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

    Also known as: Measured by a pressure gauge

06

What researchers measure

Primary outcomes

  1. Manual measurement

    Manual measurement of the pressure of injection of the local anesthetic during surgery for patients in Group 1

    Time frame: Intraoperative

Secondary outcomes

  1. 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

    Time frame: Intraoperative

07

Study locations

1 of 1 sites recruiting
  • CHOQUET
    France, Montpellier 34295, France
    • Olivier CHOQUET · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 13, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02737137
Lead sponsor
University Hospital, Montpellier
Responsible party
Sponsor
First posted
Apr 13, 2016
Start date
Jan 2016
Primary completion
Jan 2017 (estimated)
Completion
Jan 2017 (estimated)
Last update
Apr 13, 2016

Study contacts

Olivier CHOQUET, MD
Contact
o-choquet@chu-montpellier.fr
4 67 33 82 56 ext. +33
Olivier CHOQUET
principal investigator · University Hospital, Montpellier

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.

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