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CompletedNCT05572762Updated Oct 10, 2022

Assessing the Atraumatic Technique in Ophthalmic Patients

An interventional study of Cannula plastic part while applying peribulbar block and traditional technique in Intravenous Cannula Regional Ophthalmic Anesthesia, sponsored by Research Institute of Ophthalmology, Egypt. Completed at 1 site in Egypt. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-10-10.

Sponsored by Research Institute of Ophthalmology, Egypt · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 4 years 2 months after the study started (first participant enrolled May 2018, registered Jul 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Intravenous Cannula Regional Ophthalmic Anesthesia
03

In context

Lead sponsor

Research Institute of Ophthalmology, Egypt is the lead sponsor of 11 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Atraumatic Peribulbar Technique

    a cannula is used to apply ophthalmic block

    Device: Cannula plastic part while applying peribulbar block

  • Active comparator
    Conventional peribulbar block

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

    Procedure: traditional technique

Interventions

  • DeviceCannula 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.

    Also known as: Atraumatic peribulbar technique

  • Proceduretraditional 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

    Also known as: needle traumatic peribulbar anesthesia

06

What researchers measure

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

    Time frame: 3 years

07

Study locations

1 site
  • Research Institute of Ophthalmology
    Giza, 12611, Egypt
08

References and documents

Individual participant data

Plan to share: No — only the results

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 10, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05572762
Lead sponsor
Research Institute of Ophthalmology, Egypt
Responsible party
Dina Moustafa Mohamed (Researcher of Anesthesia- Research Institute of Ophthalmology, Research Institute of Ophthalmology, Egypt) — Principal investigator
First posted
Oct 10, 2022
Start date
May 1, 2018
Primary completion
Nov 30, 2021
Completion
Nov 30, 2021
Last update
Oct 10, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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