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NCT Number: NCT06767085

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

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

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Key information

Conditions

Office Hysteroscopy

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lidocaine-Prilocaine Topical

Drug

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

Saline spray

Drug

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

Primary outcomes

  1. Intensity of pain

    Time frame: 5 minutes

    Pain intensity will be assessed by visual analogue scale during the procedure.visual analogue scale ranging from 0 to 10

Secondary outcomes

  1. Intensity of pain

    Time frame: 20 minutes

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

  2. ease of insertion

    Time frame: 5 MINUTES

    ease of insertion by 10 CM VAS LIKE SCORE in which 10 means terribly difficult entry and 0 means very easy entry

Study contacts

Contact information is provided by the study sponsor or research team.

AHMED SAMY ALI ASHOUR, MD

CONTACT

[email protected]

01100681167

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 9, 2025
Registry last updated
Jan 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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