Single Injection Infromedial Peribulbar Injection in Lacrimal Duct

NCT ID: NCT04859049

Last Updated: 2022-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-10

Study Completion Date

2022-11-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain Due to Certain Specified Procedures

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group 1

Infra- medial injection of local anesthesia mixture

Group Type EXPERIMENTAL

infromedial single injection

Intervention Type PROCEDURE

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

medial canthus injection of the local anesthesia mixture

Group Type EXPERIMENTAL

medial canthus injection

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

16 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Research Institute of Ophthalmology, Egypt

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Abeer Samir Salem

Researcher of anesthesia

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

abeer salem, MD

Role: PRINCIPAL_INVESTIGATOR

research institute of ophthalmology

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Research Institute of Ophthamology

Giza, , Egypt

Site Status ENROLLING_BY_INVITATION

Research Institute of Ophthalmology

Giza, , Egypt

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

abeer salem, MD

Role: CONTACT

01125666006 ext. 002

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Abeer Samir Salem, MD

Role: primary

00201125666006

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

anesth RIO

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.