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Not yet recruiting NCT06767085

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

Phase IV Interventional Office Hysteroscopy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Lidocaine-Prilocaine Topical, Saline spray.
Who it may be relevant to
Registry conditions: Office Hysteroscopy. Basic parameters: No limits · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

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

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

Interventions

  • Drug Lidocaine-Prilocaine Topical
    lidocaine-prilocaine spray on the cervix and cervical canal 5-7 minutes prior to the procedure
  • Drug Saline spray
    saline spray on the cervix and cervical canal 5-7 minutes prior to the procedure

Primary outcome measures

  • Intensity of pain [Time frame: 5 minutes]
Secondary outcome measures (2)
  • Intensity of pain [Time frame: 20 minutes]
  • ease of insertion [Time frame: 5 MINUTES]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06767085 · LP SPRAY HYSTEROSCOPY

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗