Pain Due to Certain Specified ProceduresNCT04859049
Single Injection Infromedial Peribulbar Injection in Lacrimal Duct
A study testing infromedial single injection and medial canthus injection in people with Pain Due to Certain Specified Procedures, run by Research Institute of Ophthalmology, Egypt at 2 sites in Egypt.
Trial summary
infromedial injection of 3 ml local anesthetic drugs and assessing the pain during lacrimal duct intubation and probability of false tracking Read more about this study
- Who is it for?
- Ages 16 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain Due to Certain Specified Procedures
- What is being tested?
- infromedial single injection and medial canthus injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesEgypt
- Study dates
- 10 Sep 2021to 1 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Enrolling by invitation
Research Institute of Ophthamology
Giza, 12573
- Recruiting
Research Institute of Ophthalmology
Giza
Abeer Samir Salem, MD, 00201125666006
About this study
Official title: 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
Read the 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.
- Conditions
- Pain Due to Certain Specified Procedures
- Being tested
- infromedial single injection, medial canthus injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
infromedial single injectionProcedure or surgery
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 injectionProcedure or surgery
: We used a 25G/ 1" length needle to inject 3ml of lidocaine: bupivacaine (1:1) with 30 IU hyaluronic acid classical medial canthal injection
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Infra- medial injection of local anesthesia mixture Receives: Procedure: infromedial single injection |
| Group 2 | Experimental | medial canthus injection of the local anesthesia mixture Receives: Procedure: medial canthus injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: during surgery , study will started September 2021 & will end November 2022
Secondary outcomes (1)
surgery satisfaction using yes or no questionnaire
easiness and false tracking of the dilators
Measured: during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start10 Sep 2021
- Primary completion1 Nov 2022 (estimated)
- Study completion1 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain Due to Certain Specified ProceduresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Research Institute of Ophthalmology, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abeer Samir Salem, Research Institute of Ophthalmology, Egypt
- Investigators
- abeer salem, MD, Principal investigator, research institute of ophthalmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04859049
- Sponsor's protocol ID
- anesth RIO
- Status last verified
- Sep 2022
- First submitted
- 4 Apr 2021
- Last updated
- 21 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Effect of Single Injection Infromedial Peribulbar Injection in Lacrimal Duct Intubation Surgery in Adult Patient: Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04859049
- Acronym / sponsor ID
- anesth RIO
- Conditions
- Pain Due to Certain Specified Procedures
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Research Institute of Ophthalmology, EgyptUniversity, hospital or other
- Study start
- 10 Sep 2021 (actual)
- Primary completion
- 1 Nov 2022 (estimated)
- Study completion
- 1 Nov 2022 (estimated)
- First posted
- 26 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
infromedial injection of 3 ml local anesthetic drugs and assessing the pain during lacrimal duct intubation and probability of false tracking
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Procedure: infromedial single injectionInfra- medial injection of local anesthesia mixture |
| Group 2 | Experimental | Procedure: medial canthus injectionmedial canthus injection of the local anesthesia mixture |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| infromedial single injectionGroup 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. | Procedure or surgery | Group 1 |
| 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 | Procedure or surgery | Group 2 |
Primary outcome
Verbal rating scale (VRS) is a 5 point scale from 0 to 4 where 0 is no pain and 4 is unbearable pain
Time frame: during surgery , study will started September 2021 & will end November 2022
pain scale
1 secondary outcome
surgery satisfaction using yes or no questionnaire
Time frame: during surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
abeer salem, MD principal investigator
research institute of ophthalmology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing infromedial single injection and medial canthus injection in people with Pain Due to Certain Specified Procedures, run by Research Institute of Ophthalmology, Egypt at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact abeer salem, MD (01125666006 ext. 002, Asalem@rio.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Verbal rating scale (VRS) is a 5 point scale from 0 to 4 where 0 is no pain and 4 is unbearable pain (time frame: during surgery , study will started September 2021 & will end November 2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2022.