NCT05572762

Assessing the Atraumatic Technique in Ophthalmic Patients

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Research Institute of Ophthalmology, Egypt · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Intravenous Cannula Regional Ophthalmic Anesthesia

Interventions

Type	Name	Description
DEVICE	Cannula plastic part while applying peribulbar block	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.
PROCEDURE	traditional technique	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

Timeline

• Start date: 2018-05-01
• Primary completion: 2021-11-30
• Completion: 2021-11-30
• First posted: 2022-10-10
• Last updated: 2022-10-10

Locations

1 site across 1 country: Egypt