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
1 other identifier
interventional
50
1 country
2
Brief Summary
infromedial injection of 3 ml local anesthetic drugs and assessing the pain during lacrimal duct intubation and probability of false tracking
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2021
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 4, 2021
CompletedFirst Posted
Study publicly available on registry
April 26, 2021
CompletedStudy Start
First participant enrolled
September 10, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2022
CompletedSeptember 21, 2022
September 1, 2022
1.1 years
April 4, 2021
September 16, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
surgery satisfaction using yes or no questionnaire
during surgery
Study Arms (2)
Group 1
EXPERIMENTALInfra- medial injection of local anesthesia mixture
Group 2
EXPERIMENTALmedial canthus injection of the local anesthesia mixture
Interventions
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.
: We used a 25G/ 1" length needle to inject 3ml of lidocaine: bupivacaine (1:1) with 30 IU hyaluronic acid classical medial canthal injection
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Research Institute of Ophthamology
Giza, 12573, Egypt
Research Institute of Ophthalmology
Giza, Egypt
Study Officials
- PRINCIPAL INVESTIGATOR
abeer salem, MD
research institute of ophthalmology
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Researcher of anesthesia
Study Record Dates
First Submitted
April 4, 2021
First Posted
April 26, 2021
Study Start
September 10, 2021
Primary Completion
November 1, 2022
Study Completion
November 1, 2022
Last Updated
September 21, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share