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Transdermal Lidocaine for Pain Control During Diagnostic Office Hysteroscopy

Transdermal Lidocaine for Pain Control During Diagnostic Office Hysteroscopy: a Randomized Controlled Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04518202
Enrollment
200
Registered
2020-08-19
Start date
2020-09-01
Completion date
2021-09-30
Last updated
2020-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility, Female

Brief summary

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

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.

Interventions

5% lidocaine patch applied at 6 hours before the scheduled office hysteroscopy.

Sham patch containing no study medication applied at 6 hours before the scheduled office hysteroscopy.

Sponsors

Aswan University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

double blinded randomized controlled trial

Intervention model description

double blinded randomized controlled trial

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* patients with an indication for office hysteroscopy

Exclusion criteria

* patient refuse to participant * contraindication for lidocaine patch

Design outcomes

Primary

MeasureTime frameDescription
Pain intensity will be assessed by visual analogue scale10 minutesPain intensity will be assessed by visual analogue scale 30 minutes after the procedure. Visual analogue scale ranging from 0 to 10

Secondary

MeasureTime frameDescription
Operative time15 minutesFrom the introduction of hysteroscope into the vagina till compilation of hysteroscopic examination

Countries

Egypt

Contacts

Primary Contacthany f Sallam, md
hany.farouk@aswu.edu.eg+20102435461
Backup Contactnahla w Shady, md
hanygyne@yahoo.com+201022336052

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026