Single Injection Infromedial Peribulbar Injection in Lacrimal Duct

Not Applicable

Recruiting

• Conditions: Pain Due to Certain Specified Procedures
• Interventions: Procedure: infromedial single injection; Procedure: medial canthus injection

• Registration Number: NCT04859049
• Lead Sponsor: Research Institute of Ophthalmology, Egypt

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.

Study Timeline

• Study First Submitted: 2021-04-04
• Study First Submitted QC: 2021-04-23
• Study First Posted: 2021-04-26
• Study Start: 2021-09-10
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-16
• Last Update Posted: 2022-09-21
• Primary Completion: 2022-11-01
• Study Completion: 2022-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	infromedial single injection	Infra- medial injection of local anesthesia mixture
Group 2	medial canthus injection	medial canthus injection of the local anesthesia mixture

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
surgery satisfaction using yes or no questionnaire	during surgery	easiness and false tracking of the dilators

Trial Locations

Locations (2)

Research Institute of Ophthamology; 🇪🇬 Giza, Egypt

Research Institute of Ophthalmology; 🇪🇬 Giza, Egypt