Satisfaction Clinical Trial
Official title:
Evaluation of Deep Topical Fornix Nerve Block Versus Topical Anaesthesia in Patients Undergoing Implantable Contact Lens Procedure
General anaesthesia now a days is not the first choice in phakic intra ocular lens surgery
(Phakic IOL) , the short duration of the surgery, general anaesthesia complications,
decrease the length of hospital stay and decreasing the costs direct the interest to the
regional anaesthesia By the time the traditional retro and peribulbar injections recede to a
newer techniques that is safer and cheaper, sub tenon's block using a blunt needle took over
due to the more safety profile Even though, still serious problems can occur specially in
patients with long axial length.
Deep topical fornix nerve block anaesthesia (DTFNB) and topical anaesthesia gradually took
over with promising and successful results, decreasing length of hospital stay and
increasing patient satisfaction and fewer margins of complications.
In this study the investigators compared topical anaesthesia alone with DTFNBA in patients
undergoing posterior chamber phakic IOL surgery (Visian ICL).
102 patients scheduled for elective ICL/TICL implantation surgery were enrolled in this
study after obtaining approval from the institutional ethical committee and written patients
consent. the investigators are planning a study of matched sets of patients receiving the
case and control treatments with 1 matched control(s) per experimental subject. Prior data
indicate that the probability of a treatment failure among controls is 0.05 and the
correlation coefficient for exposure between matched experimental and control subjects is
0.1. The true odds ratio for failure in experimental subjects relative to control subjects
is 0.1, so the investigators needed to study 51 experimental subjects with 1 matched
control(s) per experimental subject to be able to reject the null hypothesis that this odds
ratio equals 1 with probability (power) 0.7. The Type I error probability associated with
this test of this null hypothesis is 0.3.
All patients were assessed and only those cooperative understanding patients who were deemed
suitable for topical and DTFNBA were included in the study. Very anxious patients were
omitted from the study.
All the operations were done by one surgeon . Patients were prepared for bilateral
implantable contact lens/toric implantable contact lens( ICL/TICL) procedure on the same
day.
Group I (1 eye) received topical anaesthetic drops and Group 2 (the second eye) received
DTFNBA. Before giving the anaesthetics, a peripheral vein was cannulated and heart rate,
oxygen saturation and non-invasive arterial blood pressure were monitored.
Topical anaesthesia was done with 2% tetracaine local anaesthetic drops and DTFNBA was
performed using two sponges (2x3mm) soaked with 0.5% bupivacaine, applied deep in the
conjunctival fornices after anaesthetising the conjunctiva with tetracaine local anaesthetic
drops. The sponges were removed after 15 minutes. The anaesthetic effect was tested by
grasping the limbus with Castroviejo 0.12 tissue forceps.
Pain was estimated by the patient using a simple pain score: no pain =0; that does not
interfere with the surgical technique, discomfort=1; the surgical technique is performed
with difficulty, pain=2; the surgeon is unable to continue the surgical technique . The
scoring was done during different stages of surgery: lid retraction while inserting a
speculum, tolerance to the microscope light, corneal incision, intraocular lens insertion,
tucking of footplates, irrigation aspiration (I/A )of viscoelastic, peripheral iridectomy.
The surgical technique was performed through a clear corneal 3.2 mm tunnel incision,
followed by sodium hyalurounate injection, ICL implantation and unfolding, tucking of
trailing footplates then side port incision and tucking of leading footplates, myostat
injection, then peripheral iridectomy . The total operative time was recorded for every
case. If the pain score was 0 or 1, no further management was required but if the pain score
was 2 at any stage, 1% preservative free lidocaine was injected intracamerally. Parametric
data were analyzed using Students t-test; non parametric data were compared using the
Chi-square test. A P value of <0.05 was considered statistically significant.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Health Services Research
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