Comparison of Sublingual Misoprostol Versus Lidocaine Spray for Hysteroscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01718314
Recruitment Status : Completed
First Posted : October 31, 2012
Last Update Posted : October 31, 2012
Information provided by (Responsible Party):
Sertac ESIN, 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

Condition or disease Intervention/treatment Phase
Pain During Hysteroscopy Drug: Sublingual Misoprostol Drug: Lidocaine pump spray Drug: Placebo (for Misoprostol) Drug: Placebo (for Lidocaine) Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 138 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Sublingual Misoprostol Versus Lidocaine Spray for Pain Relief in Office Hysteroscopy: A Randomized, Double Blind, Placebo-Controlled Trial
Study Start Date : March 2008
Actual Primary Completion Date : December 2009
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Sublingual Misoprostol & Lidocaine placebo
Misoprostol 200 µg sublingually single dose and Lidocaine spray placebo
Drug: Sublingual Misoprostol
Other Name: Cytotec

Drug: Placebo (for Lidocaine)
The pharmacy-produced sterile saline containing pump spray external characteristics identical to lidocaine pump spray

Experimental: Lidocaine Pump Spray & Misoprostol placebo
Lidocaine Pump spray, 6 sprays to cervix (60 mg totally) and sublingual misoprotol placebo
Drug: Lidocaine pump spray
Other Name: Xylocaine %10 pump spray

Drug: Placebo (for Misoprostol)
Lactose filler, the pharmacy-produced pills identical to original misoprostol pill

Primary Outcome Measures :
  1. Patient VAS score immediately after the procedure [ Time Frame: Immediately after the procedure ]

Secondary Outcome Measures :
  1. Patient VAS score 10 minutes after the procedure [ Time Frame: 10 minutes after the procedure ]

Other Outcome Measures:
  1. Need for cervical dilation [ Time Frame: During the procedure ]

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Ages Eligible for Study:   18 Years to 51 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01718314

Dr Sami Ulus Maternity and Children Training and Research Hospital
Ankara, Turkey, 06090
Sponsors and Collaborators
Dr. Sami Ulus Children's Hospital
Study Chair: Tuncay Kucukozkan, Professor Sami Ulus Maternity and Childrens Hospital

Publications of Results:
Responsible Party: Sertac ESIN, Obstetrician and Gynecologist, Dr. Sami Ulus Children's Hospital Identifier: NCT01718314     History of Changes
Other Study ID Numbers: HEK 11/33-21
First Posted: October 31, 2012    Key Record Dates
Last Update Posted: October 31, 2012
Last Verified: October 2012

Keywords provided by Sertac ESIN, Dr. Sami Ulus Children's Hospital:
Visual analogue score

Additional relevant MeSH terms:
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Anti-Ulcer Agents
Gastrointestinal Agents