Dynamic Multimodal Monitoring for Ultrasound Guided Peripheral Nerve Blockade

NCT ID: NCT02737137

Last Updated: 2016-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2017-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Orthopedic Surgery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Manual measurement by the anesthetist

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

Group Type OTHER

Manual measurement

Intervention Type PROCEDURE

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

Measurement by a pressure gauge

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

Group Type EXPERIMENTAL

Measurement with a gauge

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Manual measurement

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

Intervention Type PROCEDURE

Measurement with a gauge

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

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Manual measurement by the anesthetist Measured by a pressure gauge

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Adult patient
* Orthopedic surgery

Exclusion Criteria

* Allergy to local anesthetics
* ASA score \>III
* Severe neuropathy
* puncture site disease
* parturient or breastfeeding
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Olivier CHOQUET

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Montpellier

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHOQUET

France, Montpellier, France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Olivier CHOQUET, MD

Role: CONTACT

4 67 33 82 56 ext. +33

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Olivier CHOQUET

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2015-A01850-49

Identifier Type: REGISTRY

Identifier Source: secondary_id

9654

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.