Office HysteroscopyPhase 4NCT06767085
Pain Management During Diagnostic Office Hysteroscopy in Postmenopausal Women: a Randomized Study
A Phase 4 study testing Lidocaine-Prilocaine Topical and Saline spray in people with Office Hysteroscopy, run by Cairo University.
Trial 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 Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Office Hysteroscopy
- What is being tested?
- Lidocaine-Prilocaine Topical and Saline spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- No sites listed yet
- Study dates
- 5 Feb 2025to 25 Jul 2025
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Menopausal patients with an indication for office hysteroscopy (postmenopausal bleeding or abnormal ultrasound findings)
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Pain Management With Lidocaine-prilocaine Spray During Diagnostic Office Hysteroscopy in Postmenopausal Women: a Randomized Controlled Study
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
Read the 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
- Conditions
- Office Hysteroscopy
- Being tested
- Lidocaine-Prilocaine Topical, Saline spray
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| lidocaine prilocaine | Experimental | Not described Receives: Drug: Lidocaine-Prilocaine Topical |
| placebo | Placebo comparator | Not described Receives: Drug: Saline spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensity of pain
Pain intensity will be assessed by visual analogue scale during the procedure.visual analogue scale ranging from 0 to 10
Measured: 5 minutes
Secondary outcomes (2)
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
Measured: 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
Measured: 5 MINUTES
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start5 Feb 2025 (estimated)
- Primary completion5 Jul 2025 (estimated)
- Study completion25 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Office HysteroscopyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Samy aly ashour, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06767085
- Sponsor's protocol ID
- LP SPRAY HYSTEROSCOPY
- Status last verified
- Jan 2025
- First submitted
- 5 Jan 2025
- Last updated
- 9 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided