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

Phase 4Not Yet RecruitingNCT06767085

Cairo University106 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

106

Conditions

Office Hysteroscopy

Interventions

Lidocaine-Prilocaine TopicalDRUG

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

Saline sprayDRUG

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

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Intensity of pain

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

Time frame: 5 minutes

Secondary Outcomes

Intensity of pain

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

Time frame: 20 minutes

ease of insertion

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

Time frame: 5 MINUTES

Central Contacts

AHMED SAMY ALI ASHOUR, MD

CONTACT

01100681167 ahmedsamy8233@gmail.com

Data from ClinicalTrials.gov

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