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Transdermal Lidocaine for Pain Control During Hysterosalpingography

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: NCT04518189
Recruitment Status : Recruiting
First Posted : August 19, 2020
Last Update Posted : September 21, 2020
Sponsor:
Information provided by (Responsible Party):
hany farouk, Aswan University Hospital

Study Description
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Brief Summary:
the study aims to investigate the effectiveness of Transdermal lidocaine patch for Pain Control During Hysterosalpingography

Condition or disease Intervention/treatment Phase
Infertility, Female Drug: lidocaine patch Drug: Sham patch Not Applicable

Detailed Description:
hysterosalpingography can cause pain and discomfort in several ways: Use of the tenaculum to grasp the cervix and straighten the uterus for proper insertion; trans-cervical actions including measuring uterine depth, inserting the cannula; and injection of the dye
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: double blind randomized trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: double blind randomized trial
Primary Purpose: Prevention
Official Title: Transdermal Lidocaine for Pain Control During Hysterosalpingography: A Randomized Controlled Trial
Actual Study Start Date : September 1, 2020
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : August 31, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: lidocaine patch
5% lidocaine patch applied at 3 hours before the procedure
 Drug: lidocaine patch
lidocaine patch applied 3 hours before the procedure
Other Name: Experimental
Placebo Comparator: Sham patch
Sham patch containing no study medication applied 3 hours before the procedure
 Drug: Sham patch
Sham patch applied 3 hours before the procedure
Other Name: Placebo Comparator


Outcome Measures
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Primary Outcome Measures :
  1. Mean pain score during the procedure [ Time Frame: 10 minutes ]
    Assessment of pain using visual analog scale 0-10, 0 = minimum and 10 = maximum scores


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   any patient came for Hysterosalpingography
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • any patient came for Hysterosalpingography

Exclusion Criteria:

  • any patient has contraindication to Hysterosalpingography
Contacts and Locations
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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): NCT04518189


Contacts
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Contact: hany f Sallam, md +20102435461 ext 002 hany.farouk@aswu.edu.eg
Contact: nahla w Shady, md +201022336052 ext 002 hanygyne@yahoo.com

Locations
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Egypt
Aswan University Hospital Recruiting
Aswan, Egypt, 81528
Contact: Hany F Sallam, MD    0122336052 ext 002    hany.farouk@aswu.edu.eg   
Contact: Nahla W Shady, MD    01092440504 ext 002    nahla.elsayed@aswu.edu.eg   
Sponsors and Collaborators
Aswan University Hospital
Investigators
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Study Chair: nahla w Shady, md Aswan universirty
More Information
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Responsible Party: hany farouk, A Professor, Aswan University Hospital
ClinicalTrials.gov Identifier: NCT04518189    
Other Study ID Numbers: aswu/295/3/19
First Posted: August 19, 2020    Key Record Dates
Last Update Posted: September 21, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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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Infertility
Infertility, Female
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