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

NCT06493136 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 240

Last updated 2024-07-09

No results posted yet for this study

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

Interventions

DRUG

lidocaine gel

questionnaire

Sponsors & Collaborators

  • Institut Ophtalmologique de l'Ouest Jules Verne

    lead OTHER

Principal Investigators

  • Jean François DR Le Rouic, DOCTOR · Clinique Jules Verne

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-13
Primary Completion
2022-11-08
Completion
2023-02-05

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06493136 on ClinicalTrials.gov