Overview

This trial is active, not recruiting.

Condition anesthesia
Treatment ultrasound-guidance with echography
Sponsor University Hospital, Strasbourg, France
Start date May 2005
End date March 2009
Trial size 1002 participants
Trial identifier NCT00213954, 20050101, 3446

Summary

Nerve block anaesthesia is wildly practised in France, avoiding general anaesthesia in a number of cases and producing excellent post-operative analgesia in trauma and orthopaedic surgeries. Even realised by experimented anaesthetists, 5-15% of failures and rare complications (such as vascular puncture, paresthesia, systemic local anaesthetic toxicity, epidural and spinal anaesthesia, neuropathy) are noticed. The aim of the study is the evaluation of an ultrasound-guidance technique in the four predetermined blocks and the incidence of their complications.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Other)
Locoregional anesthesia selection
ultrasound-guidance with echography
Locoregional anesthesia with or without ultrasound guidance practice
(Other)
Locoregional anesthesia selection
ultrasound-guidance with echography
Locoregional anesthesia with or without ultrasound guidance practice
(Other)
Locoregional anesthesia selection
ultrasound-guidance with echography
Locoregional anesthesia with or without ultrasound guidance practice
(Other)
Locoregional anesthesia selection
ultrasound-guidance with echography
Locoregional anesthesia with or without ultrasound guidance practice

Primary Outcomes

Measure
Sensory and motor block quality
time frame: 15, 30 and 60 min after the block is performed

Secondary Outcomes

Measure
Complications
time frame: during the hospitalisation and by phone 1, 3, 6 and 9 months after the surgery

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patients aged 18 years and greater, scheduled for one of these blocks: interscalene, humeral, parasacral or lumbar blocks, for trauma or orthopaedic surgeries, who have consented to the study and are with social insurance registration Exclusion Criteria: - Block's contraindications, treatment by verapamil or flecainide

Additional Information

Official title Ultrasound Guidance in Nerve Block Anaesthesia: Classic Nerve Stimulation Technique Versus Ultrasound-Neurostimulation Combination in Four Blocks: Interscalene, Humeral, Parasacral and Lumbar Blocks
Principal investigator Laurence LE GOURRIER, MD
Trial information was received from ClinicalTrials.gov and was last updated in February 2009.
Information provided to ClinicalTrials.gov by University Hospital, Strasbourg, France.