NCT04518202

Brief Summary

To compare the effectiveness of Transdermal Lidocaine for Pain Control During Diagnostic Office Hysteroscopy

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

August 15, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 19, 2020

Completed
13 days until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

August 19, 2020

Status Verified

August 1, 2020

Enrollment Period

12 months

First QC Date

August 15, 2020

Last Update Submit

August 15, 2020

Conditions

Infertility, Female

Outcome Measures

Primary Outcomes (1)

  • Pain intensity will be assessed by visual analogue scale

    Pain intensity will be assessed by visual analogue scale 30 minutes after the procedure. Visual analogue scale ranging from 0 to 10

    10 minutes

Secondary Outcomes (1)

  • Operative time

    15 minutes

Study Arms (2)

lidocaine patch

EXPERIMENTAL

5% lidocaine patch applied at 6 hours before the scheduled office hysteroscopy.

Drug: lidocaine patch

Sham patch

PLACEBO COMPARATOR

Sham patch applied at 6 hours before the scheduled office hysteroscopy.

Drug: Sham patch

Interventions

lidocaine patchDRUG

5% lidocaine patch applied at 6 hours before the scheduled office hysteroscopy.

Also known as: Experimental
lidocaine patch
Sham patchDRUG

Sham patch containing no study medication applied at 6 hours before the scheduled office hysteroscopy.

Also known as: Placebo Comparator
Sham patch

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspatients with an indication for office hysteroscopy
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • patients with an indication for office hysteroscopy

You may not qualify if:

  • patient refuse to participant
  • contraindication for lidocaine patch

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aswan University Hospital

Aswān, 81528, Egypt

Location

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertility

Study Officials

  • nahla w Shady, md

    Aswan universirty

    STUDY CHAIR

Central Study Contacts

hany f Sallam, md

CONTACT

+20102435461hany.farouk@aswu.edu.eg

nahla w Shady, md

CONTACT

+201022336052hanygyne@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
double blinded randomized controlled trial
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: double blinded randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
A Professor

Study Record Dates

First Submitted

August 15, 2020

First Posted

August 19, 2020

Study Start

September 1, 2020

Primary Completion

August 31, 2021

Study Completion

September 30, 2021

Last Updated

August 19, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)