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Status unknownNCT04859049Updated Sep 21, 2022

Single Injection Infromedial Peribulbar Injection in Lacrimal Duct

An interventional study of infromedial single injection and medial canthus injection in Pain Due to Certain Specified Procedures, sponsored by Research Institute of Ophthalmology, Egypt. Status unknown at 2 sites in Egypt. Open to participants aged 16 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-21.

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

The sponsor has not verified this record recently (last verified Sep 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
16 Years to 70 Years
Sex
All
01

Study summary

infromedial injection of 3 ml local anesthetic drugs and assessing the pain during lacrimal duct intubation and probability of false tracking

Read the detailed description

After entering the OR; the patient will be cannulated and fully monitored with basic monitors (pulse oximeter, NIBP \& ECG), a nasal cannula is connected to the patient to deliver oxygen.

We gave the patient 5 ml of propofol to decrease the discomfort felt by the patient during injection of local anesthesia. Benox eye drops is applied to the operative eye in both groups.

Patients were allocated into 2 groups; each group is 25 patients Group 1: We used a 25G/ 1" length needle to inject 3ml of lidocaine: bupivacaine (1:1) with 30 IU hyaluronic acid, 0.5ml below the inferior punctum in the lower lid medial margin.

Group 2: We used a 25G/ 1" length needle to inject 3ml of lidocaine: bupivacaine (1:1) with 30 IU hyaluronic acid classical medial canthal injection

During surgery, we will assess the pain degree during probing using Verbal Rating Scale (0 to 10 scale where 0 is no pain an 10 is unbearable pain), to assess the efficiency of this single low volume injection.

02

Conditions studied

  • Pain Due to Certain Specified Procedures
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
16 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • adults undergoing lacrimal duct intubation surgery
  • Patients' physical status by the American Association of Anesthesiology (ASA): ASA I, II, III.
  • Age between 18-70, both sexes.
  • Axial lengths ranging between 22-28mm.

Exclusion criteria

Exclusion Criteria:

  • ASA IV.
  • Patient age less than 18 or more than 70 years.
  • Coagulation disorders (e.g. patients on warfarin (INR\<1.5)
  • Communication difficulties preventing reliable assessment.
  • High myopia (axial length more than 28mm) and medial staphylomas.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Group 1

    Infra- medial injection of local anesthesia mixture

    Procedure: infromedial single injection

  • Experimental
    Group 2

    medial canthus injection of the local anesthesia mixture

    Procedure: medial canthus injection

Interventions

  • Procedureinfromedial single injection

    Group 1: We used a 25G/ 1" length needle to inject 3ml of lidocaine: bupivacaine (1:1) with 30 IU hyaluronic acid, 0.5ml below the inferior punctum in the lower lid medial margin.

  • Proceduremedial canthus injection

    : We used a 25G/ 1" length needle to inject 3ml of lidocaine: bupivacaine (1:1) with 30 IU hyaluronic acid classical medial canthal injection

06

What researchers measure

Primary outcomes

  1. Verbal rating scale (VRS) is a 5 point scale from 0 to 4 where 0 is no pain and 4 is unbearable pain

    pain scale

    Time frame: during surgery , study will started September 2021 & will end November 2022

Secondary outcomes

  1. surgery satisfaction using yes or no questionnaire

    easiness and false tracking of the dilators

    Time frame: during surgery

07

Study locations

2 of 2 sites recruiting
  • Research Institute of Ophthamology
    Giza, 12573, Egypt
    Enrolling by invitation
  • Research Institute of Ophthalmology
    Giza, Egypt
    • Abeer Samir Salem, MD · Contact · 00201125666006
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

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 Sep 21, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04859049
Lead sponsor
Research Institute of Ophthalmology, Egypt
Responsible party
Abeer Samir Salem (Researcher of anesthesia, Research Institute of Ophthalmology, Egypt) — Principal investigator
First posted
Apr 26, 2021
Start date
Sep 10, 2021
Primary completion
Nov 1, 2022 (estimated)
Completion
Nov 1, 2022 (estimated)
Last update
Sep 21, 2022

Study contacts

abeer salem, MD
Contact
Asalem@rio.edu.eg
01125666006 ext. 002
abeer salem, MD
principal investigator · research institute of ophthalmology

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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

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