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Assessing the Atraumatic Technique in Ophthalmic Patients

R

Research Institute of Ophthalmology, Egypt

Status

Completed

Conditions

Intravenous Cannula Regional Ophthalmic Anesthesia

Treatments

Device: Cannula plastic part while applying peribulbar block
Procedure: traditional technique

Study type

Interventional

Funder types

Other

Identifiers

NCT05572762
22-3-27-5-2

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 2 patient groups

Atraumatic Peribulbar Technique
Experimental group
Description:
a cannula is used to apply ophthalmic block
Treatment:
Device: Cannula plastic part while applying peribulbar block
Conventional peribulbar block
Active Comparator group
Description:
a 24 or 25 gauge needle is used to provide regional o anesthesia to the study group
Treatment:
Procedure: traditional technique

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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