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

Phase 4

Not yet recruiting

• Conditions: Office Hysteroscopy
• Interventions: Drug: Lidocaine-Prilocaine Topical; Drug: Saline spray

• Registration Number: NCT06767085
• Lead Sponsor: Cairo University

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

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-05
• Study First Submitted QC: 2025-01-05
• Last Update Submitted: 2025-01-05
• Study First Posted: 2025-01-09
• Last Update Posted: 2025-01-09
• Study Start: 2025-02-05
• Primary Completion: 2025-07-05
• Study Completion: 2025-07-25

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 106

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
lidocaine prilocaine	Lidocaine-Prilocaine Topical	-
placebo	Saline spray	-

Primary Outcome Measures

Name	Time	Method
Intensity of pain	5 minutes	Pain intensity will be assessed by visual analogue scale during the procedure.visual analogue scale ranging from 0 to 10

Secondary Outcome Measures

Name	Time	Method
Intensity of pain	20 minutes	Pain intensity will be assessed by visual analogue scale 30 minutes after the procedure.visual analogue scale ranging from 0 to 10
ease of insertion	5 MINUTES	ease of insertion by 10 CM VAS LIKE SCORE in which 10 means terribly difficult entry and 0 means very easy entry