NCT07000669

Brief Summary

This study aims to evaluate the safety and efficacy of bilateral peribulbar block for cataract surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 3, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

June 3, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2025

Completed
Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

3 months

First QC Date

May 24, 2025

Last Update Submit

April 23, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Intraoperatively

Secondary Outcomes (3)

  • Patient satisfaction

    24 hours postoperatively

  • Grading of Akinesia

    Intraoperatively

  • Incidence of adverse events

    24 hours postoperatively

Study Arms (1)

Peribulbar anesthesia group

Patients undergoing bilateral peribulbar anesthesia for cataract surgery

Other: Bilateral peribulbar block

Interventions

Patients undergoing bilateral peribulbar anesthesia for cataract surgery.

Peribulbar anesthesia group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This Case series interventional study will be carried out on 50 patients undergoing cataract surgery at Tanta University Hospitals.

You may qualify if:

  • Age ≥ 18 years.
  • Both sexes.
  • American Society of Anesthesiology (ASA) physical status I-III.
  • Patients undergoing cataract surgery

You may not qualify if:

  • Infection at the site of the surgery.
  • Allergy to any of the used drugs.
  • Coagulopathy.
  • Posterior staphyloma.
  • Bronchial asthma.
  • Bradyarrhythmia.
  • Pre-existing ocular muscle paresis.
  • Neurological deficit.
  • Co-existing inflammatory conditions of eye.
  • Complicated cataracts.
  • Previously operated eyes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Anesthesiology, MAGRABI Hospital and Centers, Kingdom of Saudi Arabia

Study Record Dates

First Submitted

May 24, 2025

First Posted

June 3, 2025

Study Start

June 3, 2025

Primary Completion

August 30, 2025

Study Completion

August 30, 2025

Last Updated

April 24, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Shared Documents
STUDY PROTOCOL
Time Frame
After the end of study for one year.
Access Criteria
The data will be available upon a reasonable request from the corresponding author.

Locations