Etude de l'ANesthésie Par Gel de Lidocaïne Pour Les Injections IntrA vitréennes

NCT06493136 | Completed

• 1 other identifier: 2022-A00702-41
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Retinal Diseases - AMD - PAIN - Intravitreal Injection

Outcome Measures

Primary Outcomes (1)

• 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.

  5 minutes after IVT

Secondary Outcomes (2)

• Pain score on simple verbal scale

  5 minutes after IVT

• Hospital Anxiety and Depression Scale - Auteurs : A.S. Zigmond et R.P. Snaith

  Before the IVT

Study Arms (1)

questionnaire

questionnaire

Drug: lidocaine gel

Interventions

lidocaine gel DRUG

questionnaire

questionnaire

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients who made an appointment for an Intra Vitreous Injection (IVT) at the IOO Jules Verne during the recruitment period.

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Institut Ophtalmologique de l'Ouest Jules Verne: lead

Study Sites (1)

Institut Ophtalmologique de l'Ouest Jules Verne

Nantes, Loire Atlantique, 44300, France

Location

Study Officials

• Jean François DR Le Rouic, DOCTOR

  Clinique Jules Verne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2024
• First Posted: July 9, 2024
• Study Start: June 13, 2022
• Primary Completion: November 8, 2022
• Study Completion: February 5, 2023
• Last Updated: July 9, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)