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Transdermal Lidocaine for Pain Control During Diagnostic Office Hysteroscopy

A

Aswan University Hospital

Status

Unknown

Conditions

Infertility, Female

Treatments

Drug: lidocaine patch
Drug: Sham patch

Study type

Interventional

Funder types

Other

Identifiers

NCT04518202
aswu/296/3/19

Details and patient eligibility

About

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

Full 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.

Enrollment

200 estimated patients

Sex

Female

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • patients with an indication for office hysteroscopy

Exclusion criteria

  • patient refuse to participant
  • contraindication for lidocaine patch

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

200 participants in 2 patient groups, including a placebo group

lidocaine patch
Experimental group
Description:
5% lidocaine patch applied at 6 hours before the scheduled office hysteroscopy.
Treatment:
Drug: lidocaine patch
Sham patch
Placebo Comparator group
Description:
Sham patch applied at 6 hours before the scheduled office hysteroscopy.
Treatment:
Drug: Sham patch

Trial contacts and locations

1

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Central trial contact

hany f Sallam, md; nahla w Shady, md

Data sourced from clinicaltrials.gov

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