A Trial for Peroperative Procedure and Postoperative Pain After Rectal Misoprostol or Rectal Hyoscine Administration

Study Overview
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Brief Summary
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Dilatation of the cervix is necessary before operative hysteroscopic procedures. This dilatation with Hegar dilators has certain difficulties and is associated with pain. Cervical priming with various substances soften the cervix, ease the entry for the operation and decrease complications such as uterine perforation. The investigators aimed to compare rectally administered misoprostol and hyoscine butyl bromide with sham protocol.

Detailed Description
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The study is planned as a double blind randomised controlled one centre study. It will take part at a operative gynaecological department of a university hospital. Women who apply to the university clinic who have a medical indication for hysteroscopic surgery will be recruited after informed consent. Patients included in the study will be allocated to three groups. The intervention arms will be two arms and one sham group. The randomisation will be performed to three groups by a third party who is not involved in the surgical procedures. Upon initial evaluation, a form evaluating age and other sociodemographic characteristics will be filled out before the scheduled hysteroscopy procedure. After completion of the initial form, rectal tablets will be administered according to the allocated group; two hours previously to the procedure. Hysteroscopy will be under general anaesthesia with a 10 mm hysteroscope during the follicular phase of the menstrual cycle. During the procedure the duration of the cervical entry and total duration of the operation will be noted. Additionally basal dilatation will be noted. Two hours after the procedure pain will be documented according to the Visual Analogue Scale which is a ten point scale. A value of 1 indicates no pain. A value of 10 indicates excruciating pain.

Official Title
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A Randomised Trial for Postoperative Pain After Rectal Misoprostol or Rectal Hyoscine Administration

Conditions
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Hysteroscopic Surgery, Pain, Postoperative

Intervention / Treatment
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* Drug: Misoprostol
* Drug: Hyoscine butyl bromide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Reproductive aged women Women who are scheduled for hysteroscopy for indications of endometrial polyp, submucous myoma or synaechiae Exclusion Criteria: Women who have undergone hysteroscopy previously women who are in menopause

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Three group parallel design
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Rectal misoprostol<br>200 mcg of misoprostol will be administered rectally- 2 hours previously. This intervention will be performed by a third party health professional who will be blinded to the procedure. | Drug: Misoprostol<br>* Rectal administration 2 jours before the procedure<br>* Other names: Cytotec;|
| Active Comparator: Rectal hyoscine butyl bromide<br>10 mg hyoscine butyl bromide administered rectally- 2 hours previously. This intervention will be performed by a third party health professional who will be blinded to the procedure. | Drug: Hyoscine butyl bromide<br>* Rectal administration 2 jours before the procedure<br>* Other names: Buscopan;|
| No Intervention: Sham administration<br>A rectal examination will be performed by a third party health professional who will be blinded to the procedure. No drug will be administered | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain | Two hours after the procedure postoperative pain will be documented according to the Visual Analogue Scale which is a ten point scale. A value of 1 indicates no pain. A value of 10 indicates excruciating pain. | Postoperative 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analgesic administration | Need for analgesic administration | Postoperative 2 hours | 
| Duration of procedure | Duration of cervical dilatation and total surgery | During the surgery | 
| Ease of cervical dilatation | Ease of cervical dilatation will be evaluated using a 5 point likert scale. Very difficult Difficult Normal Easy Very easy | During the surgery | 
| Initial cervical dilatation | Initial cervical dilatation will be evaluated using the Hegar dilatator number | During the surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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misoprostol, hyoscine butyl bromide, cervical dilatation, cervical ripening, hysteroscopy, pain