Clinical trial NCT03359655: A Trial for Peroperative Procedure and Postoperative Pain After Rectal Misoprostol or Rectal Hyoscine Administration
Official title: A Randomised Trial for Postoperative Pain After Rectal Misoprostol or Rectal Hyoscine Administration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hysteroscopic Surgery
Pain, Postoperative
Keywords: misoprostol
hyoscine butyl bromide
cervical dilatation
cervical ripening
hysteroscopy
pain
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2017-12-02
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three group parallel design
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative pain
timeFrame: Postoperative 2 hours
Secondary outcomes:
measure: Analgesic administration
timeFrame: Postoperative 2 hours
measure: Duration of procedure
timeFrame: During the surgery
measure: Ease of cervical dilatation
timeFrame: During the surgery
measure: Initial cervical dilatation
timeFrame: During the surgery
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakif University
Study officials:
affiliation: Bezmialem Üniversitesi Tıp Fakültesi Hastanesi
name: Serdar G Aydin
role: PRINCIPAL_INVESTIGATOR
References: