SafetyNCT07000669
Bilateral Peribulbar Block for Cataract Surgery
An observational study of Safety and Efficacy, run by Tanta University at 1 site in Egypt.
Trial summary
This study aims to evaluate the safety and efficacy of bilateral peribulbar block for cataract surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Bilateral peribulbar block
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Jun 2025to 30 Aug 2025
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This Case series interventional study will be carried out on 50 patients undergoing cataract surgery at Tanta University Hospitals.
Who may be able to join
- Age ≥ 18 years.
- Both sexes.
- American Society of Anesthesiology (ASA) physical status I-III.
- Patients undergoing cataract surgery
Who cannot join
- Infection at the site of the surgery.
- Allergy to any of the used drugs.
- Coagulopathy.
- Posterior staphyloma.
- Bronchial asthma.
- Bradyarrhythmia.
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- Pre-existing ocular muscle paresis.
- Neurological deficit.
- Co-existing inflammatory conditions of eye.
- Complicated cataracts.
- Previously operated eyes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of Bilateral Peribulbar Block for Cataract Surgery
This study aims to evaluate the safety and efficacy of bilateral peribulbar block for cataract surgery.
Read the detailed description
Cataract surgery is one of the most commonly performed procedures worldwide, with local anesthesia being the preferred method due to its safety, efficacy, and cost-effectiveness.
Peribulbar anaesthesia has gained popularity due to its relative efficacy in generating ocular akinesia and anaesthesia with a reduced risk of consequences such as optic nerve damage and globe perforation.
- Conditions
- Safety, Efficacy, Bilateral, Peribulbar Block, Cataract Surgery
- Being tested
- Bilateral peribulbar block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral peribulbar blockOther
Patients undergoing bilateral peribulbar anesthesia for cataract surgery.
| Study group | Role | What they receive |
|---|---|---|
| Peribulbar anesthesia group | Patients undergoing bilateral peribulbar anesthesia for cataract surgery Receives: Other: Bilateral peribulbar block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of pain
The pain will be evaluated by straightforward questioning using a 3-point scoring method (no pain = 0, discomfort = 1, pain = 2) during the procedure.
Measured: Intraoperatively
Secondary outcomes (3)
Patient satisfaction
The point in time to satisfactory surgical anesthesia will be assessed on a 5-point Likert scale patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied)
Measured: 24 hours postoperatively
Grading of Akinesia
Motor block will be assessed by estimation of globe akinesia in the four quadrants, discriminated by the 4 directions of the gaze: lateral, medial, superior, and inferior. A 3- point scoring method will be chosen, in which 0 = akinesia, 1 = incomplete akinesia, and 2 = natural movement, with a total score ranging from 0-8 for the four muscles.
Measured: Intraoperatively
Incidence of adverse events
Incidence of adverse events such as coughing, vomiting, hypotension, bradycardia, tachycardia, arrhythmias, proptosis, globe puncture, or retrobulbar hemorrhage will be recorded.
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2025
- Study start3 Jun 2025
- Primary completion30 Aug 2025
- Study completion30 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SafetyStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Ibrahim Elshahawy, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07000669
- Sponsor's protocol ID
- 36264PR1192/4/25.
- Status last verified
- Apr 2026
- First submitted
- 24 May 2025
- Last updated
- 24 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Bilateral Peribulbar Block for Cataract Surgery
- ClinicalTrials.gov ID
- NCT07000669
- Acronym / sponsor ID
- 36264PR1192/4/25.
- Conditions
- Safety, Efficacy, Bilateral, Peribulbar Block, Cataract Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 3 Jun 2025 (actual)
- Primary completion
- 30 Aug 2025 (actual)
- Study completion
- 30 Aug 2025 (actual)
- First posted
- 3 Jun 2025 (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 aims to evaluate the safety and efficacy of bilateral peribulbar block for cataract surgery.
Detailed description
Cataract surgery is one of the most commonly performed procedures worldwide, with local anesthesia being the preferred method due to its safety, efficacy, and cost-effectiveness.
Peribulbar anaesthesia has gained popularity due to its relative efficacy in generating ocular akinesia and anaesthesia with a reduced risk of consequences such as optic nerve damage and globe perforation.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peribulbar anesthesia group | – | Other: Bilateral peribulbar blockPatients undergoing bilateral peribulbar anesthesia for cataract surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This Case series interventional study will be carried out on 50 patients undergoing cataract surgery at Tanta University Hospitals.
Key inclusion criteria (4 listed)
- Age ≥ 18 years.
- Both sexes.
- American Society of Anesthesiology (ASA) physical status I-III.
- Patients undergoing cataract surgery
Key exclusion criteria (11 listed)
- Infection at the site of the surgery.
- Allergy to any of the used drugs.
- Coagulopathy.
- Posterior staphyloma.
- Bronchial asthma.
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 |
|---|---|---|
| Bilateral peribulbar blockPatients undergoing bilateral peribulbar anesthesia for cataract surgery. | Other | Peribulbar anesthesia group |
Primary outcome
Degree of pain
Time frame: Intraoperatively
The pain will be evaluated by straightforward questioning using a 3-point scoring method (no pain = 0, discomfort = 1, pain = 2) during the procedure.
3 secondary outcomes
Patient satisfaction
Time frame: 24 hours postoperatively
Grading of Akinesia
Time frame: Intraoperatively
Incidence of adverse events
Time frame: 24 hours postoperatively
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 24 Apr 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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?
An observational study of Safety and Efficacy, run by Tanta University 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 4 inclusion and 11 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 24 Apr 2026. 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?
Degree of pain (time frame: Intraoperatively). 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 24 Apr 2026.