Single Injection Infromedial Peribulbar Injection in Lacrimal Duct

Pain Due to Certain Specified Procedures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04859049
• Other study ID #: anesth RIO
• Status: Recruiting
• Phase: N/A
• Start date: September 10, 2021
• Est. completion date: November 1, 2022

Study information

• Verified date: September 2022
• Source: Research Institute of Ophthalmology, Egypt
• Contact: abeer salem, MD
• Phone: 01125666006
• Email: Asalem[@]rio.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: November 1, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain Due to Certain Specified Procedures

Intervention

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.
• 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

Locations

Country	Name	City	State
Egypt	Research Institute of Ophthalmology	Giza
Egypt	Research Institute of Ophthamology	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Research Institute of Ophthalmology, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	surgery satisfaction using yes or no questionnaire	easiness and false tracking of the dilators	during surgery