Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03430453
Other study ID # UF8924
Secondary ID
Status Completed
Phase N/A
First received September 22, 2015
Last updated February 5, 2018
Start date May 1, 2012
Est. completion date December 31, 2017

Study information

Verified date September 2015
Source University Hospital, Montpellier
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of the study is define the minimal intensity of stimulation range at which the needle is closed to the nerve without penetrating its surface (epineurium layer) in ultrasound guided peripheral nerve blockade


Description:

The needle is placed at the target under ultrasound guidance the nerve stimulator is turned on and the intensity increased until motor response is observed the Minimum Intensity Observation (MIS) is recorded before injection of local anesthetic


Recruitment information / eligibility

Status Completed
Enrollment 1500
Est. completion date December 31, 2017
Est. primary completion date June 5, 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patient who need a Orthopedic surgery

- Peripheral nerve block

- More or equal to 18 years old

- I to III ASA classification status

- Benefit from an insurance regimen

Exclusion Criteria:

- severe coagulopathy

- allergy to local anesthetics

- local cutaneous lesion

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Measure of the minimal intensity of stimulation during ultrasound guided peripheral nerve blockade
A needle is placed at the target under ultrasound guidance, the nerve stimulator is turned on and the intensity increased until motor response is observed. The Minimal Intensity of Stimulation is recorded before injection of local anesthetic

Locations

Country Name City State
France University Hospital of Annecy Annecy
France University hospital of Bordeaux Bordeaux
France University hospital of Clermont-Ferrand Clermont-Ferrand
France University Hospital of Colmar Colmar
France University hospital of limoges Limoges
France University hospital of Marseille Marseille
France University Hospital of Montpellier Montpellier
France University hospital of Nice Nice
France University Hospital of Reims Reims

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Measurement of Minimum Intensity Stimulation Minimal Intensity Stimulation (MIS) was measured Using a specific nerve stimulator (modified HNS 12 B. BRAUN, Melsungen, Germany) ; the value are noted in mA. [0- 1.5].
The time frame is only related to procedure of PNB. In other term, the period of assessment should be estimated between 2 minutes and 20 minutes.
estimated between 2 minutes and 20 minutes.
Secondary tissure pressure at the target Tissue pressure at the target was measured Using a specific pressure sensor (compuflow pump Milestone Scientific, Livingston, NJ, USA) ; the value are noted in mm Hg. [0- 900].
from beginning to end of ultrasound guided peripheral nerve blockade
estimated between 2 minutes and 20 minutes.
See also
  Status Clinical Trial Phase
Completed NCT03657368 - Ventilation Strategy During General Anesthesia for Orthopedic Surgery N/A
Withdrawn NCT02771041 - Assessment of the Influence of Early Preoperative Consultation on Satisfaction and the Average Length of Stay of Patients Who Underwent Total Hip Arthroplasty N/A
Completed NCT02278627 - Impact of a Technique of Massage During the First Week of Hospitalization on the Recycling of the Mobility of the Knee Further to the Installation of Knee Replacement N/A
Recruiting NCT01205295 - Patient Anxiety and Concern as Predictors for the Perceived Quality and Efficacy of Treatment N/A
Completed NCT01389011 - Perfusion Index (PI) and Pleth Variability Index (PVI) in Patients With Interscalene Blocks in Orthopedic Surgery N/A
Completed NCT01063543 - Pharmacokinetics of Fondaparinux in Patients With Major Orthopedic Surgery N/A
Active, not recruiting NCT03629262 - Dexmedetomidine Supplemented Intravenous Analgesia in Elderly After Orthopedic Surgery Phase 4
Not yet recruiting NCT05537155 - Buccal Acupuncture for Delirium Treatment in Older Patients Recovering From Orthopedic Surgery N/A
Completed NCT03532256 - Post-op Crowd Sourcing Health Data Via Text-messaging
Active, not recruiting NCT03366805 - A Patient Education Video Program for Post-Operative Recovery After Upper Extremity Surgery N/A
Completed NCT03769077 - Cycle to Fun - 'Exergames' for Inpatient Rehabilitation for Children/Youth With CP N/A
Recruiting NCT05401058 - Low-dose Droperidol for Prevention of Postoperative Delirium in Elderly Patients After Non-cardiac Surgery N/A
Completed NCT00293631 - Study of Lornoxicam or Ketorolac or Placebo for Post-Operative Pain After Bunionectomy Phase 2
Completed NCT05110690 - Behavioral Activation and Medication Optimization for Perioperative Mental Health Feasibility Study N/A
Completed NCT05120739 - Efficacy of CHX Cloths Versus CHX Soaps for Bathes Before Orthopedic Surgery N/A
Completed NCT00702416 - Ultrasound Guidance for Interscalene Brachial Plexus Block Phase 4
Completed NCT00724035 - Ultrasound-Guided Axillary or Infraclavicular Nerve Block for Upper Limb Surgery Phase 4
Completed NCT00192894 - New Methods to Detect a Decrease in Heart Function Phase 4
Completed NCT05424211 - The Effect of Music Therapy on Pain Level and Analgesic Consumption N/A
Withdrawn NCT00269971 - A Study to Determine an Effective Dose of Epoetin Alfa to Decrease the Number of Units of Blood Required to be Transfused During Hip Replacement Surgery. Phase 3