Clinical trial NCT01718314: Comparison of Sublingual Misoprostol Versus Lidocaine Spray for Hysteroscopy
Official title: Comparison of Sublingual Misoprostol Versus Lidocaine Spray for Pain Relief in Office Hysteroscopy: A Randomized, Double Blind, Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain During Hysteroscopy
Keywords: Hysteroscopy
Misoprostol
Lidocaine
Visual analogue score
Lead sponsor: Dr. Sami Ulus Children's Hospital
Sponsor class: OTHER
First posted: 2012-10-31
Enrollment: 138
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 51
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Patient VAS score immediately after the procedure
timeFrame: Immediately after the procedure
Secondary outcomes:
measure: Patient VAS score 10 minutes after the procedure
timeFrame: 10 minutes after the procedure
Other outcomes:
measure: Need for cervical dilation
timeFrame: During the procedure
Locations:
city: Ankara
country: Turkey
facility: Dr Sami Ulus Maternity and Children Training and Research Hospital
Study officials:
affiliation: Sami Ulus Maternity and Childrens Hospital
name: Tuncay Kucukozkan, Professor
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.