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Single Injection Infromedial Peribulbar Injection in Lacrimal Duct

Assessing the Effect of Single Injection Infromedial Peribulbar Injection in Lacrimal Duct Intubation Surgery in Adult Patient: Prospective Cohort Study

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04859049
Enrollment
50
Registered
2021-04-26
Start date
2021-09-10
Completion date
2022-11-01
Last updated
2022-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain Due to Certain Specified Procedures

Brief summary

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

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.

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

Sponsors

Research Institute of Ophthalmology, Egypt
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
16 Years to 70 Years
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

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Verbal rating scale (VRS) is a 5 point scale from 0 to 4 where 0 is no pain and 4 is unbearable painduring surgery , study will started September 2021 & will end November 2022pain scale

Secondary

MeasureTime frameDescription
surgery satisfaction using yes or no questionnaireduring surgeryeasiness and false tracking of the dilators

Countries

Egypt

Contacts

Primary Contactabeer salem, MD
Asalem@rio.edu.eg01125666006

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026