Assessing the Atraumatic Technique in Ophthalmic Patients

NCT05572762 | Completed

• 1 other identifier: 22-3-27-5-2
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Intravenous Cannula Regional Ophthalmic Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Atraumatic Peribulbar Technique

EXPERIMENTAL

a cannula is used to apply ophthalmic block

Device: Cannula plastic part while applying peribulbar block

Conventional peribulbar block

ACTIVE COMPARATOR

a 24 or 25 gauge needle is used to provide regional o anesthesia to the study group

Procedure: traditional technique

Interventions

Cannula plastic part while applying peribulbar block DEVICE

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.

Also known as: Atraumatic peribulbar technique

Atraumatic Peribulbar Technique

traditional technique PROCEDURE

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

Also known as: needle traumatic peribulbar anesthesia

Conventional peribulbar block

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients
• Both
• patients going to do anterior, posterior segment surgery or cornea surgeries.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Research Institute of Ophthalmology, Egypt: lead

Study Sites (1)

Research Institute of Ophthalmology

Giza, 12611, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: the participant is going to have regional ophthalmic anesthesia, by either the atraumatic or the needle technique without being informed by which technique he is going to receive the block
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher of Anesthesia- Research Institute of Ophthalmology

Study Record Dates

• First Submitted: July 10, 2022
• First Posted: October 10, 2022
• Study Start: May 1, 2018
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2021
• Last Updated: October 10, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)