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Completed

NCT Number: NCT01718314

Comparison of Sublingual Misoprostol Versus Lidocaine Spray for Hysteroscopy

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

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Key information

Age range

18 year–51 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Dr Sami Ulus Maternity and Children Training and Research Hospital

Ankara, 06090, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sublingual misoprostol

Drug

Other names: Cytotec

Lidocaine pump spray

Drug

Other names: Xylocaine %10 pump spray

Placebo (for Misoprostol)

Drug

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

Placebo (for Lidocaine)

Drug

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

Primary outcomes

  1. Patient VAS score immediately after the procedure

    Time frame: Immediately after the procedure

Secondary outcomes

  1. Patient VAS score 10 minutes after the procedure

    Time frame: 10 minutes after the procedure

Other outcomes

  1. Need for cervical dilation

    Time frame: During the procedure

Sponsors and collaborators

Lead sponsor

Dr. Sami Ulus Children's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Oct 31, 2012
Registry last updated
Oct 31, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.