Comparison of Sublingual Misoprostol Versus Lidocaine Spray for Hysteroscopy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pain During Hysteroscopy

Intervention / Treatment
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* Drug: Sublingual Misoprostol
* Drug: Lidocaine pump spray
* Drug: Placebo (for Misoprostol)
* Drug: Placebo (for Lidocaine)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 51 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sublingual Misoprostol & Lidocaine placebo<br>Misoprostol 200 µg sublingually single dose and Lidocaine spray placebo | Drug: Sublingual Misoprostol<br> <br> * Other names: Cytotec;Drug: Placebo (for Lidocaine)<br>* The pharmacy-produced sterile saline containing pump spray external characteristics identical to lidocaine pump spray<br>|
| Experimental: Lidocaine Pump Spray & Misoprostol placebo<br>Lidocaine Pump spray, 6 sprays to cervix (60 mg totally) and sublingual misoprotol placebo | Drug: Lidocaine pump spray<br> <br> * Other names: Xylocaine %10 pump spray;Drug: Placebo (for Misoprostol)<br>* Lactose filler, the pharmacy-produced pills identical to original misoprostol pill<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient VAS score immediately after the procedure |  | Immediately after the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient VAS score 10 minutes after the procedure |  | 10 minutes after the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hysteroscopy, Misoprostol, Lidocaine, Visual analogue score