A Trial for Peroperative Procedure and Postoperative Pain After Rectal Misoprostol or Rectal Hyoscine Administration
- Conditions
- Hysteroscopic SurgeryPain, Postoperative
- Interventions
- Registration Number
- NCT03359655
- Lead Sponsor
- Bezmialem Vakif University
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 120
- Reproductive aged women
- Women who are scheduled for hysteroscopy for indications of endometrial polyp, submucous myoma or synaechiae
- Women who have undergone hysteroscopy previously
- women who are in menopause
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Rectal hyoscine butyl bromide Hyoscine butyl bromide 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. Rectal misoprostol Misoprostol 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.
- Primary Outcome Measures
Name Time Method Postoperative pain Postoperative 2 hours 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.
- Secondary Outcome Measures
Name Time Method Ease of cervical dilatation During the surgery Ease of cervical dilatation will be evaluated using a 5 point likert scale.
1. Very difficult
2. Difficult
3. Normal
4. Easy
5. Very easyAnalgesic administration Postoperative 2 hours Need for analgesic administration
Duration of procedure During the surgery Duration of cervical dilatation and total surgery
Initial cervical dilatation During the surgery Initial cervical dilatation will be evaluated using the Hegar dilatator number
Trial Locations
- Locations (1)
Bezmialem Vakif University
🇹🇷Istanbul, Turkey