Transdermal Lidocaine for Pain Control During Diagnostic Office Hysteroscopy

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ClinicalTrials.gov Identifier: NCT04518202

Recruitment Status : Not yet recruiting

First Posted : August 19, 2020

Last Update Posted : August 19, 2020

See Contacts and Locations

Sponsor:

Information provided by (Responsible Party):

hany farouk, Aswan University Hospital

Study Description

Brief Summary:

To compare the effectiveness of Transdermal Lidocaine for Pain Control During Diagnostic Office Hysteroscopy

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

Detailed Description:

hysteroscopy is commonly used in the diagnosis and treatment of intrauterine lesions such as polyps, ﬁbroids, septa, and adhesions, and in the presence of abnormal bleeding and during the removal of an intrauterine device or foreign body. Cervical ripening is made possible by the use of medication through different routes.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	200 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Intervention Model Description:	double blinded randomized controlled trial
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:	double blinded randomized controlled trial
Primary Purpose:	Prevention
Official Title:	Transdermal Lidocaine for Pain Control During Diagnostic Office Hysteroscopy: a Randomized Controlled Trial
Estimated Study Start Date :	September 1, 2020
Estimated Primary Completion Date :	August 31, 2021
Estimated Study Completion Date :	September 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Female Infertility

Drug Information available for: Lidocaine hydrochloride Lidocaine

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: lidocaine patch 5% lidocaine patch applied at 6 hours before the scheduled office hysteroscopy.	Drug: lidocaine patch 5% lidocaine patch applied at 6 hours before the scheduled office hysteroscopy. Other Name: Experimental
Placebo Comparator: Sham patch Sham patch applied at 6 hours before the scheduled office hysteroscopy.	Drug: Sham patch Sham patch containing no study medication applied at 6 hours before the scheduled office hysteroscopy. Other Name: Placebo Comparator

Outcome Measures

Primary Outcome Measures :

Pain intensity will be assessed by visual analogue scale [ Time Frame: 10 minutes ]
Pain intensity will be assessed by visual analogue scale 30 minutes after the procedure. Visual analogue scale ranging from 0 to 10

Secondary Outcome Measures :

Operative time [ Time Frame: 15 minutes ]
From the introduction of hysteroscope into the vagina till compilation of hysteroscopic examination

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 60 Years (Adult)
Sexes Eligible for Study:	Female
Gender Based Eligibility:	Yes
Gender Eligibility Description:	patients with an indication for ofﬁce hysteroscopy
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

patients with an indication for ofﬁce hysteroscopy

Exclusion Criteria:

patient refuse to participant
contraindication for lidocaine patch

Contacts and Locations

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): NCT04518202

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
Aswan, Egypt, 81528

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:	NCT04518202
Other Study ID Numbers:	aswu/296/3/19
First Posted:	August 19, 2020 Key Record Dates
Last Update Posted:	August 19, 2020
Last Verified:	August 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

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