Reinnervation of Facial Muscles After Lengthening Temporalis Myoplasty

Phase 4

Terminated

• Conditions: Facial Paresis
• Interventions: Drug: injection of 1% lidocaine, 2mL for facial nerve block

• Registration Number: NCT01833221
• Lead Sponsor: University Hospital, Caen

Brief Summary

The purpose of this study is to determine the physiology of nerve healing and the neurotization of the facial muscles after lengthening temporalis myoplasty.

Detailed Description

The investigators want to study the physiology of nerve healing after lengthening temporalis myoplasty done for facial nerve impairment. The investigators already observed few cases of spontaneous neurotization and the investigators want to check the nerve command of the facial muscles. Clinical and photographic evaluations will be performed before and after a facial nerve block using 1% lidocaine.

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-12
• Study First Submitted QC: 2013-04-15
• Study First Posted: 2013-04-16
• Status Verified: 2014-04
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Last Update Submitted: 2016-05-24
• Last Update Posted: 2016-05-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Neurotized facial muscle patients	injection of 1% lidocaine, 2mL for facial nerve block	injection of 1% lidocaine, 2mL for facial nerve block

Primary Outcome Measures

Name	Time	Method
Facial muscle contraction after nerve block	30 minutes after lidocaine injection	clinical and photographical study will be performed before and after neve block and relative contractibility state will be recorded

Trial Locations

Locations (1)

Centre Hospitalier Universitaire; 🇫🇷 Caen, Basse-normandie, France