NCT04433611

Brief Summary

To evaluate the efficacy of flushing the uterine cavity with lidocaine before Hysterosalpingo-Foam Sonography (HyFoSy) to reduce procedure-related 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
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2020

Shorter than P25 for not_applicable

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

June 7, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 16, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

June 17, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

July 28, 2020

Status Verified

May 1, 2020

Enrollment Period

4 months

First QC Date

June 7, 2020

Last Update Submit

July 26, 2020

Conditions

To Evaluate the Efficacy of Flushing the Uterine Cavity With Lidocaine Before Hysterosalpingo-Foam Sonography to Reduce Procedure-related Pain

Outcome Measures

Primary Outcomes (1)

  • visual analog scale (VAS) pain score

    The VAS consisted of a 10 cm line ranging from 0 to 10 (anchored by 0=no pain and 10=very severe pain). Patients were asked to mark the number that represented their perceived level of pain. Based on the VAS scores, the pain level ratings were classified as: mild (rated 1-3), moderate (4-6) or severe (7-10).

    22 months

Study Arms (2)

'lidocaine flushing' group

EXPERIMENTAL

intrauterine infusion of 2% lidocaine (Rafa laboratories, Israel) just prior to HyFoSy

Drug: 2% lidocaine

Placebo group

PLACEBO COMPARATOR

intrauterine infusion of 0.9 % normal saline (placebo group) just prior to HyFoSy.

Drug: 0.9 % normal saline

Interventions

2% lidocaineDRUG

intrauterine infusion of 2% lidocaine (Rafa laboratories, Israel) just prior to HyFoSy The VAS consisted of a 10 cm line ranging from 0 to 10 (anchored by 0=no pain and 10=very severe pain). Patients were asked to mark the number that represented their perceived level of pain. Based on the VAS scores, the pain level ratings were classified as: mild (rated 1-3), moderate (4-6) or severe (7-10).

'lidocaine flushing' group
0.9 % normal salineDRUG

intrauterine infusion of 0.9 % normal saline

Placebo group

Eligibility Criteria

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

You may qualify if:

  • \*all women who were referred for tubal patency evaluation as part of their fertility workup.

You may not qualify if:

  • known allergy to lidocaine.
  • unprotected intercourse.
  • profuse vaginal bleeding and genital tract inflammation or infections (e.g. pelvic inflammatory disease (PID).
  • suspected sexually transmitted diseases (purulent vaginal discharge upon speculum insertion), salpingitis or tubo-ovarian abscess).
  • psychological or neurological lesions affecting sensation, prior cervical surgery, cervical stenosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yaakov Melcer

Yavné, Select A State Or Province, 8103908, Israel

RECRUITING

Related Publications (1)

  • Melcer Y, Nimrodi M, Levinsohn-Tavor O, Gal-Kochav M, Pekar-Zlotin M, Maymon R. Analgesic Efficacy of Intrauterine Lidocaine Flushing in Hysterosalpingo-foam Sonography: A Double-blind Randomized Controlled Trial. J Minim Invasive Gynecol. 2021 Aug;28(8):1484-1489. doi: 10.1016/j.jmig.2020.11.019. Epub 2020 Nov 26.

    PMID: 33249268DERIVED

MeSH Terms

Interventions

LidocaineSaline Solution

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Yaakov Melcer

    Assaf-Harofeh Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yaakov Melcer, MD

CONTACT

0524551310ymeltcer@gmail.com

Study Design

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

Study Record Dates

First Submitted

June 7, 2020

First Posted

June 16, 2020

Study Start

June 17, 2020

Primary Completion

October 1, 2020

Study Completion

December 30, 2020

Last Updated

July 28, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will share
Shared Documents
ANALYTIC CODE
Time Frame
1 year

Locations

IL(1)