Intravenous Cannula Regional Ophthalmic AnesthesiaNCT05572762
Assessing the Atraumatic Technique in Ophthalmic Patients
A study testing Cannula plastic part while applying peribulbar block and traditional technique in people with Intravenous Cannula Regional Ophthalmic Anesthesia, run by Research Institute of Ophthalmology, Egypt at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intravenous Cannula Regional Ophthalmic Anesthesia
- What is being tested?
- Cannula plastic part while applying peribulbar block and traditional technique
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2018to 30 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients
- Both
- patients going to do anterior, posterior segment surgery or cornea surgeries.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Comparative Study Between an Atraumatic Peribulbar Block and the Traditional Peribulbar Needle Technique
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.
- Being tested
- Cannula plastic part while applying peribulbar block, traditional technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cannula plastic part while applying peribulbar blockDevice
Also called Atraumatic peribulbar technique
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.
traditional techniqueProcedure or surgery
Also called needle traumatic peribulbar anesthesia
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
| Study group | Role | What they receive |
|---|---|---|
| Atraumatic Peribulbar Technique | Experimental | a cannula is used to apply ophthalmic block Receives: 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 Receives: Procedure: traditional technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start1 May 2018
- Primary completion30 Nov 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intravenous Cannula Regional Ophthalmic AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Research Institute of Ophthalmology, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Moustafa Mohamed, Research Institute of Ophthalmology, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05572762
- Sponsor's protocol ID
- 22-3-27-5-2
- Status last verified
- Oct 2022
- First submitted
- 10 Jul 2022
- Last updated
- 10 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: only the results
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Comparative Study Between an Atraumatic Peribulbar Block and the Traditional Peribulbar Needle Technique
- ClinicalTrials.gov ID
- NCT05572762
- Acronym / sponsor ID
- 22-3-27-5-2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Research Institute of Ophthalmology, EgyptUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 10 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atraumatic Peribulbar Technique | Experimental | Device: Cannula plastic part while applying peribulbar blocka cannula is used to apply ophthalmic block |
| Conventional peribulbar block | Active comparator | Procedure: traditional techniquea 24 or 25 gauge needle is used to provide regional o anesthesia to the study group |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients
- Both
- patients going to do anterior, posterior segment surgery or cornea surgeries.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cannula plastic part while applying peribulbar blockAlso: Atraumatic peribulbar techniqueUsing 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. | Device | Atraumatic Peribulbar Technique |
| traditional techniqueAlso: needle traumatic peribulbar anesthesiathe 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 | Procedure or surgery | Conventional peribulbar block |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2022.
- Individual participant dataSharing planned: No. only the results
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cannula plastic part while applying peribulbar block and traditional technique in people with Intravenous Cannula Regional Ophthalmic Anesthesia, run by Research Institute of Ophthalmology, Egypt at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safe Ophthalmic block using Globe Akinesia Score by Sarvela (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2022.