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Evaluation of Deep Topical Fornix Nerve Block Versus Topical Anaesthesia Procedure

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ClinicalTrials.gov Identifier: NCT02196441
Recruitment Status : Unknown
Verified July 2014 by Hassan Mohamed Ali, Cairo University.
Recruitment status was:  Not yet recruiting
First Posted : July 22, 2014
Last Update Posted : July 22, 2014
Sponsor:
Information provided by (Responsible Party):
Hassan Mohamed Ali, Cairo University

Tracking Information
First Submitted Date  ICMJE July 16, 2014
First Posted Date  ICMJE July 22, 2014
Last Update Posted Date July 22, 2014
Study Start Date  ICMJE August 2014
Estimated Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 18, 2014)
Measure of pain free surgery and Tolerability [ Time Frame: during the surgical procedure, 15 minutes ]
the patient will be examined for optimum pain free condition (anesthesia)that allow the surgeon to proceed
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2014)
patient satisfaction [ Time Frame: one hour post operative ]
Patient satisfaction concerning the procedure using a 2-point scale (1=satisfied, I would want the same anaesthesia/analgesia method for the next surgery, 2=unsatisfied, I would want a different anaesthesia/ analgesia method for the next surgery)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Deep Topical Fornix Nerve Block Versus Topical Anaesthesia Procedure
Official Title  ICMJE Evaluation of Deep Topical Fornix Nerve Block Versus Topical Anaesthesia in Patients Undergoing Implantable Contact Lens Procedure
Brief Summary

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).

Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Local Anesthesia
  • Satisfaction
Intervention  ICMJE
  • Drug: 2% tetracaine local anaesthetic drops
    topical anaesthetic drops
    Other Name: topical anaesthetic drops
  • Drug: 0.5% bupivacaine
    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.
    Other Name: Deep topical fornix nerve block anaesthesia
Study Arms  ICMJE
  • Experimental: Group 2
    0.5% bupivacaine Deep topical fornix nerve block anaesthesia (DTFNB)
    Intervention: Drug: 0.5% bupivacaine
  • Experimental: Group 1
    2% tetracaine local anaesthetic drops
    Intervention: Drug: 2% tetracaine local anaesthetic drops
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 18, 2014)
102
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2014
Estimated Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • cooperative understanding patients

Exclusion Criteria:

  • Very anxious patients
  • coagulopathy
  • refusal
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Saudi Arabia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02196441
Other Study ID Numbers  ICMJE 1234656
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hassan Mohamed Ali, Cairo University
Study Sponsor  ICMJE Cairo University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Hassan M Ali, Lecturer Cairo University
PRS Account Cairo University
Verification Date July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP