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Efficacy of Uterine Lidocaine Flushing in HyFoSy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04433611
Recruitment Status : Recruiting
First Posted : June 16, 2020
Last Update Posted : July 28, 2020
Sponsor:
Information provided by (Responsible Party):
Assaf-Harofeh Medical Center

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

Condition or disease Intervention/treatment Phase
To Evaluate the Efficacy of Flushing the Uterine Cavity With Lidocaine Before Hysterosalpingo-Foam Sonography to Reduce Procedure-related Pain Drug: 2% lidocaine Drug: 0.9 % normal saline Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Analgesic Efficacy of Intrauterine Lidocaine Flushing in Hysterosalpingo-foam Sonography: A Double-blind Randomized Controlled Trial
Actual Study Start Date : June 17, 2020
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 'lidocaine flushing' group
intrauterine infusion of 2% lidocaine (Rafa laboratories, Israel) just prior to HyFoSy
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).


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




Primary Outcome Measures :
  1. visual analog scale (VAS) pain score [ Time Frame: 22 months ]
    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).



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04433611


Contacts
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Contact: Yaakov Melcer, MD 0524551310 ymeltcer@gmail.com

Locations
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Israel
Yaakov Melcer Recruiting
Yavne, Select A State Or Province, Israel, 8103908
Contact: Yaakov Melcer    0524551310    ymeltcer@gmail.com   
Sponsors and Collaborators
Assaf-Harofeh Medical Center
Investigators
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Principal Investigator: Yaakov Melcer Assaf-Harofeh Medical Center
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Responsible Party: Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier: NCT04433611    
Other Study ID Numbers: # 0189-19
First Posted: June 16, 2020    Key Record Dates
Last Update Posted: July 28, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Analytic Code
Time Frame: 1 year

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Flushing
Skin Manifestations
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action