NCT03359655

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Bezmialem Vakif University · Academic / Other
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hysteroscopic Surgery
• Pain, Postoperative

Interventions

Type	Name	Description
DRUG	Misoprostol	Rectal administration 2 jours before the procedure
DRUG	Hyoscine butyl bromide	Rectal administration 2 jours before the procedure

Timeline

• Start date: 2018-06-11
• Primary completion: 2018-12-04
• Completion: 2018-12-13
• First posted: 2017-12-02
• Last updated: 2018-12-27

Locations

1 site across 1 country: Turkey (Türkiye)