A Randomised Trial for Postoperative Pain After Rectal Misoprostol or Rectal Hyoscine Administration
| Registry | NCT03359655 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: quadruple, diagnostic |
| Enrollment | 120 (Actual) |
| Sponsor | Bezmialem Vakif University (Other) |
| Conditions | Hysteroscopic Surgery, Pain, Postoperative |
| Interventions | Misoprostol, Hyoscine butyl bromide (Drug) |
| Dates | start 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 in Turkey (Türkiye) |
Related Papers Related Patents Related Grants Related Experts
All trials for Hysteroscopic Surgery All trials for Pain, Postoperative All trials of Misoprostol All trials of Hyoscine butyl bromide
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Rectal misoprostol | Active comparator | Drug: 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. |
| Rectal hyoscine butyl bromide | Active comparator | Drug: 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. |
| Sham administration | No intervention | A rectal examination will be performed by a third party health professional who will be blinded to the procedure. No drug will be administered |
Sex: Female, ages: 18 Years to 55 Years, 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
| Facility | City | Country | Status |
|---|---|---|---|
| Bezmialem Vakif University | Istanbul | Turkey (Türkiye) |