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

Cairo University (CU)

Status and phase: Not yet enrolling; Phase 4

Conditions: Office Hysteroscopy

Treatments: Drug: Lidocaine-Prilocaine Topical; Drug: Saline spray

Study type: Interventional

Funder types: Other

Identifiers

NCT06767085

LP SPRAY HYSTEROSCOPY

Details and patient eligibility

About

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

Full 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

Enrollment: 106 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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106 participants in 2 patient groups, including a placebo group

lidocaine prilocaine

Experimental group

Treatment:

Drug: Lidocaine-Prilocaine Topical

placebo

Placebo Comparator group

Treatment:

Drug: Saline spray