NCT03382743

Brief Summary

lidocaine spray is used endocervical before office hysteroscopy to reduce the pain

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 phase_2

Timeline
Completed

Started Dec 2017

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

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

December 19, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

December 20, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 26, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

January 24, 2018

Status Verified

January 1, 2018

Enrollment Period

2 months

First QC Date

December 19, 2017

Last Update Submit

January 23, 2018

Conditions

Pain Uterus

Keywords

office hysteroscopyLidocaine spray

Outcome Measures

Primary Outcomes (2)

  • Pain sensation

    The level of pelvic pain will be rated according to a 10-point visual analogue scale (VAS)

    The VAS will be applied immediately after the procedure ended

  • Procedure time

    from introduction of the office hysteroscopy through the external cervical os and the visualization of the uterine cavity

    immediately after the process

Study Arms (2)

Group A (Lidocaine group)

ACTIVE COMPARATOR

5 sprays of endocervical Lidocaine 10% spray ( AstraZeneca, bedforshire) are used 3 minutes before office hysteroscopy

Drug: Endocervical Lidocaine spray

Group B (control group)

NO INTERVENTION

office hysteroscopy is done without analgesia

Interventions

Endocervical Lidocaine sprayDRUG

5 sprays of endocervical Lidocaine spray (10%) is used 3 minutes before office hysteroscopy

Group A (Lidocaine group)

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients indicated for diagnostic hysteroscopy for infertility or AUB. Postmenstrual between days 7 and 11 of the cycle ( except in irregular bleeding)

You may not qualify if:

  • Contraindication to office hysteroscopy Neurological disorders affecting the evaluation of pain. Previous cervical surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kasr El Ainiy Hospital

Cairo, 11562, Egypt

RECRUITING

Kasr Alaini hospital

Cairo, Egypt

RECRUITING

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator ,lecturer of obstetrics and gynecology

Study Record Dates

First Submitted

December 19, 2017

First Posted

December 26, 2017

Study Start

December 20, 2017

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

January 24, 2018

Record last verified: 2018-01

Locations

EG(2)