Assessing the Atraumatic Technique in Ophthalmic Patients

Not Applicable

Completed

• Conditions: Intravenous Cannula Regional Ophthalmic Anesthesia
• Interventions: Device: Cannula plastic part while applying peribulbar block; Procedure: traditional technique

• Registration Number: NCT05572762
• Lead Sponsor: Research Institute of Ophthalmology, Egypt

Brief Summary

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

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.

Study Timeline

• Study Start: 2018-05-01
• Primary Completion: 2021-11-30
• Study Completion: 2021-11-30
• Study First Submitted: 2022-07-10
• Status Verified: 2022-10
• Study First Submitted QC: 2022-10-06
• Last Update Submitted: 2022-10-06
• Study First Posted: 2022-10-10
• Last Update Posted: 2022-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Adult patients
2. Both
3. patients going to do anterior, posterior segment surgery or cornea surgeries.

Exclusion Criteria

1. Pediatric population
2. Mentally retarded patients
3. Patients having Problems to lie flat, refused to take regional
4. Patients with communication problems as; language barrier, deaf and mute.
5. Patients with bleeding diathesis.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Atraumatic Peribulbar Technique	Cannula plastic part while applying peribulbar block	a cannula is used to apply ophthalmic block
Conventional peribulbar block	traditional technique	a 24 or 25 gauge needle is used to provide regional o anesthesia to the study group

Primary Outcome Measures

Name	Time	Method
Safe Ophthalmic block using Globe Akinesia Score by Sarvela	3 years	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

Trial Locations

Locations (1)

Research Institute of Ophthalmology; 🇪🇬 Giza, Egypt