NCT03530488

Brief Summary

women candidate for office hystroscopy were randomized to either flushing of the endocervix and endometrium with 4 ml lidocaine 2% diluted in 15 ml normal saline or 19 ml normal saline before office hystroscopy

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
250

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2018

Shorter than P25 for phase_4

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

Study Start

First participant enrolled

May 1, 2018

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

May 8, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 21, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

May 21, 2018

Status Verified

May 1, 2018

Enrollment Period

7 months

First QC Date

May 8, 2018

Last Update Submit

May 18, 2018

Conditions

Pain During Hystroscopy

Outcome Measures

Primary Outcomes (1)

  • Pain assessment during the hysteroscopy

    pain assessment during hystroscopy using visual analogue scale VAS. is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100

    during hystroscopy procedure

Secondary Outcomes (3)

  • Pain assessment 10 minutes after hysteroscopy

    10 minutes after hysteroscopy

  • Pain assessment 30 minutes after hysteroscopy

    30 minutes after hysteroscopy

  • Pain assessment 60 minutes after hysteroscopy

    60 minutes after hysteroscopy

Study Arms (2)

Lidocaine group

ACTIVE COMPARATOR

intrauterine and intracervical instillation of 4 ml of lidocaine 2% diluted in 15 ml normal saline 5 minutes before hystroscopy

Drug: LidocaineProcedure: Office hystroscopy

control group

PLACEBO COMPARATOR

intrauterine and intracervical instillation of 19 ml normal saline 5 minutes before hystroscopy

Procedure: Office hystroscopy

Interventions

LidocaineDRUG

intrauterine and intracervical instillation of 4 ml of lidocaine 2% diluted in 15 ml normal saline

Lidocaine group
Office hystroscopyPROCEDURE

A rigid 3.5 mm hystroscope with an optic of 30 degrees was used. Normal saline solution was used as distension media, with 120 mmHg intrauterine pressure, Vaginoscopic approach, nocervical tenaculum or dilators used.

Lidocaine groupcontrol group

Eligibility Criteria

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

You may qualify if:

  • all women indicated for office hysteroscopy for evaluation of the uterine cavity eg: AUB, infertility

You may not qualify if:

  • Women allergic to local anesthesia those required operative hysteroscopy under general anesthesia pelvic inflammatory disease known cervical malignancy profuse uterine bleeding, marked cervical stenosis recent uterine perforation previous cervical surgery and neurological disorders affecting evaluation of pain using other products that could affect the consistency of the cervix such as local estrogen, misoprostol or laminaire are contraindications for office hystroscopy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr Alainy medical school

Cairo, 12111, Egypt

Location

Related Publications (1)

  • Shoab AY, Maged AM, Ramadan W, Dahab S, Deeb WS, Ali YZA, Mostafa WAI, Hussein EA. The value of endocervical and endometrial lidocaine flushing before office hysteroscopy: A randomized controlled trial. Int J Gynaecol Obstet. 2020 Jan;148(1):113-117. doi: 10.1002/ijgo.12992. Epub 2019 Oct 19.

    PMID: 31593299DERIVED

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Ahmed Maged

    professor

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Maged, MD

CONTACT

+2001005227404prof.ahmedmaged@gmail.com

Amira Shoab, MD

CONTACT

+2001005647376amira_el_sayed_yehia@hotmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

May 8, 2018

First Posted

May 21, 2018

Study Start

May 1, 2018

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

May 21, 2018

Record last verified: 2018-05

Locations

EG(1)