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

Bezmialem Vakif University

Status: Completed

Conditions: Pain, Postoperative; Hysteroscopic Surgery

Treatments: Drug: Misoprostol; Drug: Hyoscine butyl bromide

Study type: Interventional

Funder types: Other

Identifiers

NCT03359655

2017-6-

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 3 patient groups

Rectal misoprostol

Active Comparator group

Description:

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.

Treatment:

Drug: Misoprostol

Rectal hyoscine butyl bromide

Active Comparator group

Description:

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.

Treatment:

Drug: Hyoscine butyl bromide

Sham administration

No Intervention group

Description:

A rectal examination will be performed by a third party health professional who will be blinded to the procedure. No drug will be administered