Completed

NCT Number: NCT05572762

Assessing the Atraumatic Technique in Ophthalmic Patients

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.

Completed

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Key information

Conditions

Intravenous Cannula Regional Ophthalmic Anesthesia

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Research Institute of Ophthalmology

Giza, 12611, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: 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

Other names: needle traumatic peribulbar anesthesia

Primary outcomes

Safe Ophthalmic block using Globe Akinesia Score by Sarvela

Time frame: 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

Sponsors and collaborators

Lead sponsor

Research Institute of Ophthalmology, Egypt

Other

Registry information

Official study title

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

Important dates

Study start: 2018
Primary completion: 2021
Study completion: 2021
First posted: Oct 10, 2022
Registry last updated: Oct 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.