Assessing the Atraumatic Technique in Ophthalmic Patients

Study Overview
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Brief Summary
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This study is conducted to determine the efficacy of the cannula atraumatic technique as an alternative to the traditional needle penetrating technique to minimize the incidence of accidental globe penetration and/ or perforation, as the plastic part of the cannula is blunt and is difficult to perforate the normal globe being marble-like in consistency.

Detailed Description
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A prospective comparative single blinded randomized controlled clinical study was held in the operating theatre at Research institute of ophthalmology, on adult patients with age group between 18- 80 years of both sexes undergoing anterior, posterior segment or plastic surgeries. two techniques were used in comparison: the atraumatic technique, using a 20 or 22-gauge cannula advanced in the inferior-temporal peribulbar space after local infiltration. The skin and the conjunctiva will be pierced by the cannula and advanced for only 0.5 cm, then the cannula will be advanced blindly. Supplementation using the other sites (medial canthus and superior nasal) as needed.

Official Title
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A Prospective Comparative Study Between an Atraumatic Peribulbar Block and the Traditional Peribulbar Needle Technique

Conditions
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Intravenous Cannula Regional Ophthalmic Anesthesia

Intervention / Treatment
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* Device: Cannula plastic part while applying peribulbar block
* Procedure: traditional technique


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients Both patients going to do anterior, posterior segment surgery or cornea surgeries. Exclusion Criteria: Pediatric population Mentally retarded patients Patients having Problems to lie flat, refused to take regional Patients with communication problems as; language barrier, deaf and mute. Patients with bleeding diathesis.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Atraumatic Peribulbar Technique<br>a cannula is used to apply ophthalmic block | Device: Cannula plastic part while applying peribulbar block<br>* Using the cannula and introducing it peribulbar to apply regional ophthalmic anesthesia avoiding by this causing trauma to the globe, as the normal globe consistency is marble-like, the cannula can't puncture except in case of presence of staphyloma, so the cannula will either curve around it or will be kinked causing failure of the technique.<br>* Other names: Atraumatic peribulbar technique;|
| Active Comparator: Conventional peribulbar block<br>a 24 or 25 gauge needle is used to provide regional o anesthesia to the study group | Procedure: traditional technique<br>* the patients are going to receive the local anesthetic standard of care technique by using 23- or 24-gauge needle introduced through the skin extra-conal and local anesthetic solution will be injected with volume AND concentration according to the surgery going to be done<br>* Other names: needle traumatic peribulbar anesthesia;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safe Ophthalmic block using Globe Akinesia Score by Sarvela | A scoring system out of 12 to assess the four recti muscles, orbicularis oculi and the levator palpebri superioris degree of akinesia post regional anesthesia where 2 is full movement 0 is total block, and also the anesthesia is assessed where 2 is full sensation and 0 is considered total anesthesia | 3 years |