NCT02737137

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 13, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

April 13, 2016

Status Verified

January 1, 2016

Enrollment Period

1 year

First QC Date

March 1, 2016

Last Update Submit

April 12, 2016

Conditions

Orthopedic Surgery

Outcome Measures

Primary Outcomes (1)

  • Manual measurement

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

    Intraoperative

Secondary Outcomes (1)

  • Measured by a pressure gauge

    Intraoperative

Study Arms (2)

Manual measurement by the anesthetist

OTHER

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

Procedure: Manual measurement

Measurement by a pressure gauge

EXPERIMENTAL

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

Manual measurementPROCEDURE

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

Also known as: Manual measurement by the anesthetist
Manual measurement by the anesthetist
Measurement with a gaugePROCEDURE

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
Measurement by a pressure gauge

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patient
  • Orthopedic surgery

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHOQUET

France, Montpellier, 34295, France

RECRUITING

MeSH Terms

Interventions

Weights and Measures

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Olivier CHOQUET

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Olivier CHOQUET, MD

CONTACT

4 67 33 82 56o-choquet@chu-montpellier.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2016

First Posted

April 13, 2016

Study Start

January 1, 2016

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

April 13, 2016

Record last verified: 2016-01

Locations

FR(1)