Retinal Diseases - AMD - PAIN - Intravitreal InjectionANGLIANCT06493136
Etude de l'ANesthésie Par Gel de Lidocaïne Pour Les Injections IntrA vitréennes
An observational study of Retinal Diseases - AMD - PAIN - Intravitreal Injection, run by Institut Ophtalmologique de l'Ouest Jules Verne at 1 site in France.
Trial summary
Purpose To assess the efficacy of preservative-free Lidocaine gel 2% (LG) in patients complaining of pain during intravitreal injection (IVI) despite standard topical anaesthesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinal Diseases - AMD - PAIN - Intravitreal Injection
- What is being tested?
- lidocaine gel
- How many people
- 240 participants
- Where
- 1 siteFrance
- Study dates
- 13 Jun 2022to 5 Feb 2023
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients who made an appointment for an Intra Vitreous Injection (IVT) at the IOO Jules Verne during the recruitment period.
Who may be able to join
- Patient with a VAS score during the 1st assessment: VAS ≥ 4/10
- Patients who have given their consent to switch to the protocol with the addition of lidocaine gel (information letter provided and collection of non-objection)
Who cannot join
- Persons cited in articles L.1121-6 to L.1121-8 of the CSP
- Patients not followed at the IOO Jules Verne or at the Hauts Pavés practice.
- Eye pain before the procedure
- Intravitreal injections performed with oftriamcinolone acetonide
- Intravitreal injections performed with a larger gauge needle (Ozurdex® or Iluvien ®)
- Intravitreal injections performed using a disinfectant other than povidone iodine
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- Patients for whom the protocol with lidocaine gel in anesthesia is already used
- Any cortisone injection
- Any uveitic inflammatory pathology whether immunological or infectious
- Anyone under systemic treatment with cortisone or morphine and its derivatives
Trial locations and contacts
1 site in 1 country.
France1 site
Institut Ophtalmologique de l'Ouest Jules Verne
Nantes, Loire Atlantique, 44300
About this study
Purpose To assess the efficacy of preservative-free Lidocaine gel 2% (LG) in patients complaining of pain during intravitreal injection (IVI) despite standard topical anaesthesia.
Methods First phase: prospective selection of a group of painful patients (score pain ≥ 4 on Visual Analogic Scale) during IVI with anaesthetic drops. Determination of the anxiety score before IVI, the overall pain score and pain score related to the speculum after IVI. Painful patients were proposed to enter the second phase of the study and have the next IVI with LG. Pain scores and anxiety score after each method of anaesthesia were compared.
Read more
Results In a group of 240 patients, 62 (25%) described pain≥4 despite anaesthetic drops. 39 patients (16.3%), accepted anaesthesia with LG for the next IVI. During IVI with LG, 27 patients (69%) had pain<4 (P<0.001). The average pain score for IVI with LG was 3.32+/-2.45 versus 5.71 +/-1.45 for anaesthetic drops (P<0.001). Pain score due to speculum placement was 1.54+/-1.96 for LG versus 2.66+/-2.57 for drops (P=0.02). Anxiety score before IVI was 8.08+/-3.63 for LG versus 7.84+/-3.84 with drops (P=0.4). 27 patients (69%) wanted to have subsequent IVIs with LG.
Conclusion In a selected group of painful patients, anaesthesia with Lidocaine gel provided a statistically significant decrease of the pain score during IVI and the speculum placement pain score. The similarity of anxiety score before each method of anaesthesia, suggests that the reduction of pain score was truly due to a superior anaesthetic effect of LG.
Read the detailed description
Introduction Déterminer l'efficacité d'une anesthésie topique par gel de Lidocaine à 2% (GL) à la place de l'oxybuprocaine chez les patients se plaignant d'une douleur importante lors des injections intravitréennes. (IVT) avec une aiguille 30 gauge.
Matériels et Méthodes Première phase: réalisation d'un premier interrogatoire parmi des patients ayant des IVT unilatérales réalisées par six praticiens pour déterminer 1) la douleur après IVT avec ovybuprocaine, 2) la douleur liée au blépharostat et 3) l'anxiété avant IVT par l'Hospital Anxiety and Depression Scale , et sélectionner un groupe de patients se plaignant d'une douleur ≥ 4 sur une échelle visuelle analogique (EVA) de la douleur et acceptant aussi une anesthésie par GL lors de la prochaine IVT (groupe étudié). Deuxième phase : réalisation d'un deuxième interrogatoire sur le groupe étudié pour déterminer la douleur ressentie après GL (critère principal), déterminer l'anxiété avant les IVT et la douleur lors de la pose du blépharostat. (critères secondaires).
Résultats Sur un groupe de 240 patients 62 (25%) ont décrit une douleur ≥ 4. 39 patients (16,3%) dont 32 femmes (82%) - Age moyen 77 ans ont accepté une anesthésie par GL et ont constitué le groupe étudié. Après IVT avec GL 27 patients (70%) avaient une douleur < 4 (P< 0,001). Le score moyen de douleur après IVT était de 5,71 +/- 1,45 pour l'oxyburpocaine contre 3,32 +/- 2,45 pour le GL (P< 0,001). Lors de la pose du blépharostat la douleur était de 2,66 +/- 2,57 avec l'oxybuprocaine contre 1,54 +/- 1,96 avec le GL (P= 0,02). Le score d'anxiété avant IVT était de 7,84 +/- 3,84 avant IVT avec oxybuprocaine contre 8,08 +/- 3,63 (P=0,4). 27 patients (69%) souhaitaient avoir des IVT ultérieures avec du GL.
Discussion Le gel de Lidocaine possède une autorisation de mise sur le marché pour la chirurgie ophtalmologique. Dans notre étude, il a permis une réduction significative du score de douleur après IVT en comparaison avec une anesthésie précédente par oxybuprocaine. Il a aussi permis une réduction de la douleur lors de la pose du blépharostat. Ce médicament est pour l'instant réservé à un usage professionnel et n'est pas disponible en officine ce qui restreint son utilisation aux IVT réalisées dans des établissements de santé.
Conclusion L'utilisation de Gel de Lidocaine a permis une réduction significative de la douleur après IVT chez un groupe de patients algiques et plus des deux tiers d'entre eux souhaitaient poursuivre les IVT avec ce type d'anesthésique.
- Being tested
- lidocaine gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lidocaine gelDrug
questionnaire
| Study group | Role | What they receive |
|---|---|---|
| questionnaire | questionnaire Receives: Drug: lidocaine gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale : pain score
VAS score: The figure should be rounded to the nearest millimetre. Comparison of the pain felt during the injection during the 1st evaluation (with conventional anaesthesia) to the pain score pain score obtained with improved anaesthesia.
Measured: 5 minutes after IVT
Secondary outcomes (2)
Pain score on simple verbal scale
Confirmation of pain relief with the simple verbal scale score
Measured: 5 minutes after IVT
Hospital Anxiety and Depression Scale - Auteurs : A.S. Zigmond et R.P. Snaith
Description of the patient's psychological state during an iVT and validation of score stability
Measured: Before the IVT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2024
- Study start13 Jun 2022
- Primary completion8 Nov 2022
- Study completion5 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal Diseases - AMD - PAIN - Intravitreal InjectionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Ophtalmologique de l'Ouest Jules Verne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean François DR Le Rouic, DOCTOR, Principal investigator, Clinique Jules Verne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06493136
- Sponsor's protocol ID
- 2022-A00702-41
- Acronym
- ANGLIA
- Status last verified
- Jun 2024
- First submitted
- 25 Jun 2024
- Last updated
- 9 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etude de l'ANesthésie Par Gel de Lidocaïne Pour Les Injections IntrA vitréennes
- ClinicalTrials.gov ID
- NCT06493136
- Acronym / sponsor ID
- ANGLIA / 2022-A00702-41
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Institut Ophtalmologique de l'Ouest Jules VerneUniversity, hospital or other
- Study start
- 13 Jun 2022 (actual)
- Primary completion
- 8 Nov 2022 (actual)
- Study completion
- 5 Feb 2023 (actual)
- First posted
- 9 Jul 2024 (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.
Purpose To assess the efficacy of preservative-free Lidocaine gel 2% (LG) in patients complaining of pain during intravitreal injection (IVI) despite standard topical anaesthesia.
Methods First phase: prospective selection of a group of painful patients (score pain ≥ 4 on Visual Analogic Scale) during IVI with anaesthetic drops. Determination of the anxiety score before IVI, the overall pain score and pain score related to the speculum after IVI. Painful patients were proposed to enter the second phase of the study and have the next IVI with LG. Pain scores and anxiety score after each method of anaesthesia were compared.
Results In a group of 240 patients, 62 (25%) described pain≥4 despite anaesthetic drops. 39 patients (16.3%), accepted anaesthesia with LG for the next IVI. During IVI with LG, 27 patients (69%) had pain<4 (P<0.001). The average pain score for IVI with LG was 3.32+/-2.45 versus 5.71 +/-1.45 for anaesthetic drops (P<0.001). Pain score due to speculum placement was 1.54+/-1.96 for LG versus 2.66+/-2.57 for drops (P=0.02). Anxiety score before IVI was 8.08+/-3.63 for LG versus 7.84+/-3.84 with drops (P=0.4). 27 patients (69%) wanted to have subsequent IVIs with LG.
Conclusion In a selected group of painful patients, anaesthesia with Lidocaine gel provided a statistically significant decrease of the pain score during IVI and the speculum placement pain score. The similarity of anxiety score before each method of anaesthesia, suggests that the reduction of pain score was truly due to a superior anaesthetic effect of LG.
Detailed description
Introduction Déterminer l'efficacité d'une anesthésie topique par gel de Lidocaine à 2% (GL) à la place de l'oxybuprocaine chez les patients se plaignant d'une douleur importante lors des injections intravitréennes. (IVT) avec une aiguille 30 gauge.
Matériels et Méthodes Première phase: réalisation d'un premier interrogatoire parmi des patients ayant des IVT unilatérales réalisées par six praticiens pour déterminer 1) la douleur après IVT avec ovybuprocaine, 2) la douleur liée au blépharostat et 3) l'anxiété avant IVT par l'Hospital Anxiety and Depression Scale , et sélectionner un groupe de patients se plaignant d'une douleur ≥ 4 sur une échelle visuelle analogique (EVA) de la douleur et acceptant aussi une anesthésie par GL lors de la prochaine IVT (groupe étudié). Deuxième phase : réalisation d'un deuxième interrogatoire sur le groupe étudié pour déterminer la douleur ressentie après GL (critère principal), déterminer l'anxiété avant les IVT et la douleur lors de la pose du blépharostat. (critères secondaires).
Résultats Sur un groupe de 240 patients 62 (25%) ont décrit une douleur ≥ 4. 39 patients (16,3%) dont 32 femmes (82%) - Age moyen 77 ans ont accepté une anesthésie par GL et ont constitué le groupe étudié. Après IVT avec GL 27 patients (70%) avaient une douleur < 4 (P< 0,001). Le score moyen de douleur après IVT était de 5,71 +/- 1,45 pour l'oxyburpocaine contre 3,32 +/- 2,45 pour le GL (P< 0,001). Lors de la pose du blépharostat la douleur était de 2,66 +/- 2,57 avec l'oxybuprocaine contre 1,54 +/- 1,96 avec le GL (P= 0,02). Le score d'anxiété avant IVT était de 7,84 +/- 3,84 avant IVT avec oxybuprocaine contre 8,08 +/- 3,63 (P=0,4). 27 patients (69%) souhaitaient avoir des IVT ultérieures avec du GL.
Discussion Le gel de Lidocaine possède une autorisation de mise sur le marché pour la chirurgie ophtalmologique. Dans notre étude, il a permis une réduction significative du score de douleur après IVT en comparaison avec une anesthésie précédente par oxybuprocaine. Il a aussi permis une réduction de la douleur lors de la pose du blépharostat. Ce médicament est pour l'instant réservé à un usage professionnel et n'est pas disponible en officine ce qui restreint son utilisation aux IVT réalisées dans des établissements de santé.
Conclusion L'utilisation de Gel de Lidocaine a permis une réduction significative de la douleur après IVT chez un groupe de patients algiques et plus des deux tiers d'entre eux souhaitaient poursuivre les IVT avec ce type d'anesthésique.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| questionnaire | – | Drug: lidocaine gelquestionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who made an appointment for an Intra Vitreous Injection (IVT) at the IOO Jules Verne during the recruitment period.
Key inclusion criteria (2 listed)
- Patient with a VAS score during the 1st assessment: VAS ≥ 4/10
- Patients who have given their consent to switch to the protocol with the addition of lidocaine gel (information letter provided and collection of non-objection)
Key exclusion criteria (10 listed)
- Persons cited in articles L.1121-6 to L.1121-8 of the CSP
- Patients not followed at the IOO Jules Verne or at the Hauts Pavés practice.
- Eye pain before the procedure
- Intravitreal injections performed with oftriamcinolone acetonide
- Intravitreal injections performed with a larger gauge needle (Ozurdex® or Iluvien ®)
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 |
|---|---|---|
| lidocaine gelquestionnaire | Drug | questionnaire |
Primary outcome
Visual Analog Scale : pain score
Time frame: 5 minutes after IVT
VAS score: The figure should be rounded to the nearest millimetre. Comparison of the pain felt during the injection during the 1st evaluation (with conventional anaesthesia) to the pain score pain score obtained with improved anaesthesia.
2 secondary outcomes
Pain score on simple verbal scale
Time frame: 5 minutes after IVT
Hospital Anxiety and Depression Scale - Auteurs : A.S. Zigmond et R.P. Snaith
Time frame: Before the IVT
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2024.
- 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.
Jean François DR Le Rouic, DOCTOR principal investigator
Clinique Jules Verne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retinal Diseases - AMD - PAIN - Intravitreal Injection, run by Institut Ophtalmologique de l'Ouest Jules Verne at 1 site in France.
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 2 inclusion and 10 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: finished, as of the sponsor's last update on 9 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale : pain score (time frame: 5 minutes after IVT). 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 9 Jul 2024; AzTrials last refreshed its copy on 8 Nov 2026.