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Single Injection Infromedial Peribulbar Injection in Lacrimal Duct

R

Research Institute of Ophthalmology, Egypt

Status

Enrolling

Conditions

Pain Due to Certain Specified Procedures

Treatments

Procedure: infromedial single injection
Procedure: medial canthus injection

Study type

Interventional

Funder types

Other

Identifiers

NCT04859049
anesth RIO

Details and patient eligibility

About

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

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

16 to 70 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

50 participants in 2 patient groups

Group 1
Experimental group
Description:
Infra- medial injection of local anesthesia mixture
Treatment:
Procedure: infromedial single injection
Group 2
Experimental group
Description:
medial canthus injection of the local anesthesia mixture
Treatment:
Procedure: medial canthus injection

Trial contacts and locations

2

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Central trial contact

abeer salem, MD

Data sourced from clinicaltrials.gov

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