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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 13 June 2016
Main ID:  NCT01833221
Date of registration: 12/04/2013
Prospective Registration: No
Primary sponsor: University Hospital, Caen
Public title: Reinnervation of Facial Muscles After Lengthening Temporalis Myoplasty FacialReinn
Scientific title: Study of the Reinnervation of Facial Muscles After Lengthening Temporalis Myoplasty
Date of first enrolment: April 2013
Target sample size: 10
Recruitment status: Terminated
URL:  https://clinicaltrials.gov/show/NCT01833221
Study type:  Interventional
Study design:  Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science  
Phase:  Phase 4
Countries of recruitment
France
Contacts
Name:     Daniel LabbĂ©, MD
Address: 
Telephone:
Email:
Affiliation:  University Hospital, Caen
Key inclusion & exclusion criteria

Inclusion Criteria:

- patient who were operated for a facial paralysis by the lengthening temporalis
myoplasty procedure in the University Hospital of Caen and who present signs of
contraction of the facial muscles on the plasy side after the procedure.

Exclusion Criteria:

- Patient with contraindications to the injection of lidocaine

- Patient treated with beta-blocker

- Patient on anti-coagulants

- Pathology cause of facial paralysis evolving

- Pregnant or lactating

- Patient incapacitated adult

- Patient undergoing another study at the same time



Age minimum: 6 Years
Age maximum: 70 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Facial Paresis
Intervention(s)
Drug: injection of 1% lidocaine, 2mL for facial nerve block
Primary Outcome(s)
Facial muscle contraction after nerve block [Time Frame: 30 minutes after lidocaine injection]
Secondary Outcome(s)
Secondary ID(s)
10-159
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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