Facial Paresis Clinical Trial
Official title:
Using the Deep Temporal Nerves Versus the Masseteric Nerve for Correction of Eyelid Paresis Caused by Facial Nerve Affection. A Comparative Clinical Study.
The return of eyelid function and facial expression in Patients with facial nerve affection
is very important for quality of life. Eyelid dysfunction leads to drying and ulceration of
cornea which may lead to permanent vision loss.
Facial paralysis is distinguished into two main groups according to the presence or absence
of facial fibrillations at needle Electromyography. Recent paralysis, mainly lasting less
than two years generally show these signs and are eligible for reactivation of facial nerve
by anastomosing it to a donor one (early facial reanimation).
The masseteric nerve (motor branch of trigeminal nerve ) is a reliable donor nerve on early
facial reanimation.
The deep temporal nerves are motor branches of trigeminal nerve which have some advantage
over masseteric nerve as they are longer and reach the zygomatic and frontal branch of facial
nerve and it can reach the eyelid and eyebrow to be used for direct neurotization and it
supplies temporalis muscle which is an expandable muscle with little effect on mastication
and it was reported that they can restore blinking.
So on this study we examine the advantages and disadvantages of both nerves to develop a
protocol for use of both especially on eyelid reanimation and restoration of blinking on
upper facial segment paresis
Type of the study: Prospective Interventional Study (clinical trial)
Intervention Model Description:
Patients will be randomized into two groups according to the surgical procedure performed as
follows:
- Group A: Deep temporal nerves.
- Group B: Masseteric nerve.
Allocation and Randomization:
Twenty-four patients will be randomly assigned to Group A or Group B (2 equal groups).
Simple randomization will be performed before surgery by a research nurse using the
closed-envelope technique.
Twenty-four closed envelopes will be used, each 12 of them carries one of the 2 groups.
Closed envelope will be randomly withdrawn the night before surgery to assign the patient to
his specific group.
Study Setting: Plastic and Reconstructive Surgery Department, Assuit University Hospital
Study subjects:
Inclusion criteria:
1. Facial nerve paresis with upper eyelid affection.
2. Patients are generally fit with no other disease interfere with microsurgery.
3. Electromyography of eyelid showing fibrillations. b. Exclusion criteria:
1. Patient with other medical or mental disease causing generalized paralysis. 2. Syndromic
cases. 3. Patients are generally unfit or with any disease interfere with microsurgery.
4. Electromyography of eyelid showing no fibrillations.
Sample Size Calculation: 24 Sample size was calculated using G power program version 3.1.9.4
(6) in order to detect a significant difference in mean of palpebral fissure height (one of
main assessed outcomes in the study ) between two groups under the study , assumed effect
size 0.6 based on clinical assumption ( novel study ), α error 0.3 , power 0.80, and
allocation ratio 1: 1.
Twenty-two patient plus 10% for dropouts to make total twenty-four (12 patient for every
group).
Study tools
All patients in this study are subjected to:
Pre-operative Assessment:
1. Patient history.
2. All patients will do preoperative clinical and neurophysiological assessments of mimetic
muscle function and donor nerve status (the ipsilateral deep temporal nerve. The
neurophysiological tests will include needle Electromyography (EMG) for recruitment of
residual motor unit action potential. If there are no fibrillations patients will have
another surgical procedure.
3. The trigeminal motor component will be tested by palpating the temporalis muscle during
chewing and via needle EMG of the temporalis muscle to verify availability as a donor
motor nerve.
4. Photographic documentation preoperative using standardized frontal face view and adding
a scale to photo to measure the palpebral fissure size during three states normal eye
opening, resting eye closure and forced eye closure using ImageJ (image processing and
analysis in java) computer software (7).
5. Ophthalmological assessment of the affected eye for detection of redness, ulcer, etc.
Surgical procedure:
Group A We will avoid the use of muscle relaxants to induce anaesthesia and employ an
electro-stimulator to identify the deep temporal nerves and the facial nerve branches
supplying the eyelid on the affected side.
Exploration on the affected side a facelift-type incision will be performed, and an anterior
subcutaneous flap is then will be lifted for several centimetres. In the inferior zygomatic
region, the plane of elevation is deepened into the sub-SMAS plane and a composite flap
elevated for several centimetres. Following elevation in this plane, the distal facial nerve
branches will be identified. The distal portion of the zygomatic nerve is usually located
midway between the oral commissure and the helical root. and was confirmed by nerve
stimulator.
The deep temporal fascia and temporalis muscle will be incised along the temporal fusion line
and will be reflected from the skull to expose the divisions of the deep temporal nerves and
the longest branch was traced and prepared for anastomosis end to end with the zygomatic
branch after confirming the eyelid supply(8).
Then suction drain will be put and will be removed after 24 hours. Group B The same procedure
except tracing the masseteric nerve related to masseter muscle and anastomosis will be the
same (9).
Post-operative All patient will receive physiotherapy and post-operative follow up to detect
any wound complication.
Evaluation (After 6 months from the operation)
1. Photo documentation: measurement of the palpebral fissure size during three states
normal eye opening, resting eye closure , forced eye closure will be done adding eye
closure during mastication to compare with preoperative resting eye closure measure
using ImageJ (image processing and analysis in java) computer software(7).
2. Donor site morbidity.
3. Follow up Ophthalmological assessment.
Complications:
1. General surgical complication.
2. General complication due to general anaesthesia.
3. Specific complication:
1. Delayed healing of nerve anastomosis.
2. Affection of mastication.
3. No postoperative improvement.
Research outcome measures:
a. Primary (main): Comparing the outcomes on palpebral fissure size between the deep temporal
group and the masseteric group after 6 months from the surgery.
a. Secondary (subsidiary):
1. Procedure-related morbidity and mortality.
2. Operative time and hospital stay.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT01833221 -
Reinnervation of Facial Muscles After Lengthening Temporalis Myoplasty
|
Phase 4 |