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Pain Management During Diagnostic Office Hysteroscopy in Postmenopausal Women: a Randomized Study

Pain Management With Lidocaine-prilocaine Spray During Diagnostic Office Hysteroscopy in Postmenopausal Women: a Randomized Controlled Study

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06767085
Enrollment
106
Registered
2025-01-09
Start date
2025-02-05
Completion date
2025-07-25
Last updated
2025-01-09

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

Conditions

Office Hysteroscopy

Brief summary

To assess the effectiveness of lidocaine-prilocaine spray versus placebo in minimizing the pain experienced by postmenopausal patients during diagnostic office hysteroscopy and to assess the ease of insertion of hysteroscope as reported by the hysteroscopists

Detailed description

To assess the effectiveness of lidocaine-prilocaine spray versus placebo in minimizing the pain experienced by postmenopausal patients during diagnostic office hysteroscopy and to assess the ease of insertion of hysteroscope as reported by the hysteroscopists

Interventions

DRUGLidocaine-Prilocaine Topical

lidocaine-prilocaine spray on the cervix and cervical canal 5-7 minutes prior to the procedure

DRUGSaline spray

saline spray on the cervix and cervical canal 5-7 minutes prior to the procedure

Sponsors

Cairo University
Lead SponsorOTHER

Study design

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

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

Inclusion criteria

* Menopausal patients with an indication for office hysteroscopy (postmenopausal bleeding or abnormal ultrasound findings)

Exclusion criteria

* Nulliparous patients patients with cervical pathology retroverted uterus (detected by transvaginal ultrasound) previous cervical surgery patients with severe vaginal bleeding allergy or contraindications to lidocaine-prilocaine spray

Design outcomes

Primary

MeasureTime frameDescription
Intensity of pain5 minutesPain intensity will be assessed by visual analogue scale during the procedure.visual analogue scale ranging from 0 to 10

Secondary

MeasureTime frameDescription
Intensity of pain20 minutesPain intensity will be assessed by visual analogue scale 30 minutes after the procedure.visual analogue scale ranging from 0 to 10
ease of insertion5 MINUTESease of insertion by 10 CM VAS LIKE SCORE in which 10 means terribly difficult entry and 0 means very easy entry

Contacts

Primary ContactAHMED SAMY ALI ASHOUR, MD
ahmedsamy8233@gmail.com01100681167

Outcome results

None listed

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