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

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

Study Overview

• Status: Completed
• Conditions: Pain During Hysteroscopy
• Intervention / Treatment: Drug: Sublingual Misoprostol; Drug: Placebo (for Lidocaine); Drug: Lidocaine pump spray; Drug: Placebo (for Misoprostol)

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
• Enrollment (Actual): 138
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06090
    • Dr Sami Ulus Maternity and Children Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 49 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sublingual Misoprostol & Lidocaine placebo; Misoprostol 200 µg sublingually single dose and Lidocaine spray placebo	Drug: Sublingual Misoprostol; Other Names: 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 Names: Xylocaine %10 pump spray; Drug: Placebo (for Misoprostol); Lactose filler, the pharmacy-produced pills identical to original misoprostol pill

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Time Frame
Need for cervical dilation	During the procedure

Collaborators and Investigators

• Sponsor: Dr. Sami Ulus Children's Hospital
• Investigators: Study Chair: Tuncay Kucukozkan, Professor, Sami Ulus Maternity and Childrens Hospital

Publications and helpful links

General Publications

• van Dongen H, de Kroon CD, Jacobi CE, Trimbos JB, Jansen FW. Diagnostic hysteroscopy in abnormal uterine bleeding: a systematic review and meta-analysis. BJOG. 2007 Jun;114(6):664-75. doi: 10.1111/j.1471-0528.2007.01326.x.
• De Iaco P, Marabini A, Stefanetti M, Del Vecchio C, Bovicelli L. Acceptability and pain of outpatient hysteroscopy. J Am Assoc Gynecol Laparosc. 2000 Feb;7(1):71-5. doi: 10.1016/s1074-3804(00)80012-2.
• Mulayim B, Celik NY, Onalan G, Bagis T, Zeyneloglu HB. Sublingual misoprostol for cervical ripening before diagnostic hysteroscopy in premenopausal women: a randomized, double blind, placebo-controlled trial. Fertil Steril. 2010 May 1;93(7):2400-4. doi: 10.1016/j.fertnstert.2009.01.073. Epub 2009 Feb 24.

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): March 1, 2010

Study Registration Dates

• First Submitted: October 29, 2012
• First Submitted That Met QC Criteria: October 30, 2012
• First Posted (Estimate): October 31, 2012

Study Record Updates

• Last Update Posted (Estimate): October 31, 2012
• Last Update Submitted That Met QC Criteria: October 30, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: Lidocaine; Misoprostol; Hysteroscopy; Visual analogue score
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Gastrointestinal Agents; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Lidocaine; Misoprostol
• Other Study ID Numbers: HEK 11/33-21