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Efficacy of Uterine Lidocaine Flushing in HyFoSy

NCT04433611 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2020-07-28

No results posted yet for this study

Summary

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

Conditions

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

Interventions

DRUG

2% lidocaine

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).

DRUG

0.9 % normal saline

intrauterine infusion of 0.9 % normal saline

Sponsors & Collaborators

  • Assaf-Harofeh Medical Center

    lead OTHER_GOV

Principal Investigators

  • Yaakov Melcer · Assaf-Harofeh Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-17
Primary Completion
2020-10-01
Completion
2020-12-30

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04433611 on ClinicalTrials.gov