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

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

Study Overview

• Status: Recruiting
• Conditions: Pain Due to Certain Specified Procedures
• Intervention / Treatment: Procedure: infromedial single injection; Procedure: medial canthus injection

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: abeer salem, MD; Phone Number: 002 01125666006; Email: Asalem@rio.edu.eg

Study Locations

• Egypt
  • Giza, Egypt, 12573
    • Enrolling by invitation
    • Research Institute of Ophthamology
  • Giza, Egypt
    • Recruiting
    • Research Institute of Ophthalmology
    • Contact: Abeer Samir Salem, MD; Phone Number: 00201125666006

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; Infra- medial injection of local anesthesia mixture	Procedure: infromedial 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.
Experimental: Group 2; medial canthus injection of the local anesthesia mixture	Procedure: medial 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	during surgery , study will started September 2021 & will end November 2022

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
surgery satisfaction using yes or no questionnaire	easiness and false tracking of the dilators	during surgery

Collaborators and Investigators

• Sponsor: Research Institute of Ophthalmology, Egypt

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2021
• Primary Completion (Anticipated): November 1, 2022
• Study Completion (Anticipated): November 1, 2022

Study Registration Dates

• First Submitted: April 4, 2021
• First Submitted That Met QC Criteria: April 23, 2021
• First Posted (Actual): April 26, 2021

Study Record Updates

• Last Update Posted (Actual): September 21, 2022
• Last Update Submitted That Met QC Criteria: September 16, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: anesth RIO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No