NCT06962709

Brief Summary

Investigating whether warmed lidocaine increases analgesic effect for intravitreal injections

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 12, 2024

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 8, 2025

Completed
Last Updated

May 8, 2025

Status Verified

April 1, 2025

Enrollment Period

11 months

First QC Date

February 24, 2025

Last Update Submit

April 29, 2025

Conditions

Pain Intensity AssessmentPain Management

Keywords

warmed lidocaineintravitreal injections

Outcome Measures

Primary Outcomes (1)

  • Pain Rating

    The level of pain associated with intravitreal injection as marked by patient on 10cm line.

    immediately after the intervention

Study Arms (2)

Patients receiving warmed lidocaine

EXPERIMENTAL

Patients receive lidocaine jelly that has been warmed before they receive an intravitreal injection.

Other: Warmed lidocaine

Patients receiving room temperature lidocaine

NO INTERVENTION

Patients receive room temperature lidocaine before intravitreal injection

Interventions

Warmed lidocaineOTHER

Lidocaine warmed to 98 F

Patients receiving warmed lidocaine

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Receiving intravitreal injection for any indication

You may not qualify if:

  • Previous participant in study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital - Mason Eye Clinic

Columbia, Missouri, 65212, United States

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

February 24, 2025

First Posted

May 8, 2025

Study Start

June 12, 2024

Primary Completion

May 1, 2025

Study Completion

May 1, 2025

Last Updated

May 8, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)