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Comparison of Sublingual Misoprostol Versus Lidocaine Spray for Hysteroscopy

Comparison of Sublingual Misoprostol Versus Lidocaine Spray for Pain Relief in Office Hysteroscopy: A Randomized, Double Blind, Placebo-Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01718314
Enrollment
138
Registered
2012-10-31
Start date
2008-03-31
Completion date
2010-03-31
Last updated
2012-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain During Hysteroscopy

Keywords

Hysteroscopy, Misoprostol, Lidocaine, Visual analogue score

Brief summary

Hysteroscopy is an instrument to visualize the interior walls of uterus (womb) and it enables the doctor to do minor operative procedures. Although it causes little discomfort, sometimes it may be disturbing for the patient. This pain is usually perceived during the passage of the instrument through the cervix (neck of the womb). The investigators would like to minimize this pain by two drugs: Misoprotol and lidocaine

Detailed description

Outpatient or office hysteroscopy has become the 'gold standard' for the investigation of the intrauterine abnormalities. This minimal invasive modality provides brilliant and clear visualization of the entire uterine cavity and besides this, by the operative channel, minor procedures may easily be performed in the office setting which is priceless for the gynecologist. However, pain related to the procedure may make the procedure uncomfortable for the patient and the physician. Together with the operative time, hysteroscope diameter is considered as the main factor influencing pain. The pain perceived during hysteroscopy may be reduced by using a smaller diameter hysteroscope or by using anesthesia, which decreases pain perception. In this prospective, randomized, double blind, placebo controlled study, we aim to compare the effectiveness of sublingual misoprostol versus lidocaine pump spray for pain relief during office hysteroscopy.

Interventions

DRUGLidocaine pump spray
DRUGPlacebo (for Misoprostol)

Lactose filler, the pharmacy-produced pills identical to original misoprostol pill

DRUGPlacebo (for Lidocaine)

The pharmacy-produced sterile saline containing pump spray external characteristics identical to lidocaine pump spray

Sponsors

Dr. Sami Ulus Children's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 51 Years
Healthy volunteers
No

Inclusion criteria

* Premenopausal women in the proliferative phase of the menstrual cycle with no contraindication for hysteroscopy

Exclusion criteria

* vaginal bleeding at the time of the procedure * known sensitivity to lidocaine (amide group local anesthetics) or prostaglandins * epilepsy * significantly impaired respiratory or cardiac conduction functions * hypertension * glaucoma * renal failure * acute liver disease * uncontrolled diabetes mellitus * pregnancy or suspicion of pregnancy * pelvic inflammatory disease * cervical operation history * vaginismus.

Design outcomes

Primary

MeasureTime frame
Patient VAS score immediately after the procedureImmediately after the procedure

Secondary

MeasureTime frame
Patient VAS score 10 minutes after the procedure10 minutes after the procedure

Other

MeasureTime frame
Need for cervical dilationDuring the procedure

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026