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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03359655
• Other study ID #: 2017-6-
• Status: Completed
• Phase: N/A
• Start date: June 11, 2018
• Est. completion date: December 13, 2018

Study information

• Verified date: December 2018
• Source: Bezmialem Vakif University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 13, 2018
• Est. primary completion date: December 4, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Hysteroscopic Surgery
• Pain, Postoperative

Intervention

Drug:
• Misoprostol
Rectal administration 2 jours before the procedure
• Hyoscine butyl bromide
Rectal administration 2 jours before the procedure

Locations

Country	Name	City	State
Turkey	Bezmialem Vakif University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Analgesic administration	Need for analgesic administration	Postoperative 2 hours
Secondary	Duration of procedure	Duration of cervical dilatation and total surgery	During the surgery
Secondary	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
Secondary	Initial cervical dilatation	Initial cervical dilatation will be evaluated using the Hegar dilatator number	During the surgery