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

NCT ID: NCT06767085

Last Updated: 2025-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-05

Study Completion Date

2025-07-25

Brief Summary

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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

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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

Conditions

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Office Hysteroscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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lidocaine prilocaine

Group Type EXPERIMENTAL

Lidocaine-Prilocaine Topical

Intervention Type DRUG

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

placebo

Group Type PLACEBO_COMPARATOR

Saline spray

Intervention Type DRUG

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

Interventions

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Lidocaine-Prilocaine Topical

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

Intervention Type DRUG

Saline spray

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

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Samy aly ashour

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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AHMED SAMY ALI ASHOUR, MD

Role: CONTACT

01100681167

Other Identifiers

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LP SPRAY HYSTEROSCOPY

Identifier Type: -

Identifier Source: org_study_id

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