Comparison of Sublingual Misoprostol Versus Lidocaine Spray for Hysteroscopy

Not Applicable

Completed

• Conditions: Pain During Hysteroscopy
• Interventions: Drug: Sublingual Misoprostol; Drug: Lidocaine pump spray; Drug: Placebo (for Lidocaine); Drug: Placebo (for Misoprostol)

• Registration Number: NCT01718314
• Lead Sponsor: Dr. Sami Ulus Children's Hospital

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.

Study Timeline

• Study Start: 2008-03
• Primary Completion: 2009-12
• Study Completion: 2010-03
• Status Verified: 2012-10
• Study First Submitted: 2012-10-29
• Study First Submitted QC: 2012-10-30
• Last Update Submitted: 2012-10-30
• Study First Posted: 2012-10-31
• Last Update Posted: 2012-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 138

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sublingual Misoprostol & Lidocaine placebo	Sublingual Misoprostol	Misoprostol 200 µg sublingually single dose and Lidocaine spray placebo
Sublingual Misoprostol & Lidocaine placebo	Placebo (for Lidocaine)	Misoprostol 200 µg sublingually single dose and Lidocaine spray placebo
Lidocaine Pump Spray & Misoprostol placebo	Lidocaine pump spray	Lidocaine Pump spray, 6 sprays to cervix (60 mg totally) and sublingual misoprotol placebo
Lidocaine Pump Spray & Misoprostol placebo	Placebo (for Misoprostol)	Lidocaine Pump spray, 6 sprays to cervix (60 mg totally) and sublingual misoprotol placebo

Primary Outcome Measures

Name	Time	Method
Patient VAS score immediately after the procedure	Immediately after the procedure

Secondary Outcome Measures

Name	Time	Method
Patient VAS score 10 minutes after the procedure	10 minutes after the procedure

Trial Locations

Locations (1)

Dr Sami Ulus Maternity and Children Training and Research Hospital; 🇹🇷 Ankara, Turkey