Comparison Between the Intrauterine Lidocaine and Warm Saline Distention Medium for Pain Relief D… (NCT06946121) | Clinical Trial Compass
CompletedNot Applicable
Comparison Between the Intrauterine Lidocaine and Warm Saline Distention Medium for Pain Relief During Office Hysteroscopy
Egypt100 participantsStarted 2024-09-30
Plain-language summary
Procedure:
The procedure was done in the lithotomy position during the postmenstrual period.
We used a 30° angle 2.9 mm rigid hysteroscopy with 3.8 mm diagnostic sheath \[TEKNO®, LIGHT XA 180, Germany\].
Vaginoscopic approach was used for insertion of the hysteroscopy in all cases (no use of speculum or tenaculum).
The hysteroscopy was gently introduced into the uterine cavity after visualization of the cervix and identification of the external os.
We used saline as the distension medium and the maximum pressure was set at 70 to 80 mm Hg by an automated hysteroscopic pump system (Hysteromat II, Karl Storz), which automatically measured intrauterine fluid pressure. In lidocaine group: we added 5 ml of lidocaine 2% to 500 ml of saline solution that was used as a distention medium.
The uterine cavity and tubal ostia were systematically visualized. All procedures were done by an operator using the same equipment.
Who can participate
Age range
18 Years – 60 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Age ≥ 18 years old.
Indications of diagnostic office hysteroscopy as:
Suspicion of the intracavitary lesion. Abnormal uterine bleeding. Abnormal endometrial thickening. Postmenopausal bleeding. Mullerian congenital anomaly. Removal of foreign bodies. Undergoing the procedure to assess the endocervical canal, uterine cavity, and tubal ostia for infertility.
Exclusion Criteria:
* Patients with contra-indications of diagnostic hysteroscopy as:
Unable to exclude pregnancy Acute pelvic infection Active genital herpes Profuse bleeding at the time of the procedure. Any usage of analgesic agent on the day of the procedure. Failure of entry of the cervical canal requiring cervical dilatation. Any additional procedure during the procedure: polypectomy, biopsy and adhesiolysis.
Patient refusal to participate in the study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pain score
Timeframe: at time of hysteroscopy and 15 minutes after it