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

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Hysteroscopic Surgery
• Intervention / Treatment: Drug: Misoprostol; Drug: Hyoscine butyl bromide

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34093
    • Bezmialem Vakif University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Rectal 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.	Drug: Misoprostol; Rectal administration 2 jours before the procedure; Other Names: Cytotec
ACTIVE_COMPARATOR: Rectal 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.	Drug: Hyoscine butyl bromide; Rectal administration 2 jours before the procedure; Other Names: Buscopan
NO_INTERVENTION: Sham administration; A rectal examination will be performed by a third party health professional who will be blinded to the procedure. No drug will be administered

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analgesic administration	Need for analgesic administration	Postoperative 2 hours
Duration of procedure	Duration of cervical dilatation and total surgery	During the surgery
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
Initial cervical dilatation	Initial cervical dilatation will be evaluated using the Hegar dilatator number	During the surgery

Collaborators and Investigators

• Sponsor: Bezmialem Vakif University
• Investigators: Principal Investigator: Serdar G Aydin, Bezmialem Üniversitesi Tıp Fakültesi Hastanesi

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 11, 2018
• Primary Completion (ACTUAL): December 4, 2018
• Study Completion (ACTUAL): December 13, 2018

Study Registration Dates

• First Submitted: November 7, 2017
• First Submitted That Met QC Criteria: November 27, 2017
• First Posted (ACTUAL): December 2, 2017

Study Record Updates

• Last Update Posted (ACTUAL): December 27, 2018
• Last Update Submitted That Met QC Criteria: December 24, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: pain; hysteroscopy; misoprostol; cervical ripening; cervical dilatation; hyoscine butyl bromide
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Antiemetics; Gastrointestinal Agents; Adjuvants, Anesthesia; Anticonvulsants; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Mydriatics; Misoprostol; Bromides; Scopolamine; Butylscopolammonium Bromide
• Other Study ID Numbers: 2017-6-

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The results will be published
• IPD Sharing Time Frame: After the study is completed
• IPD Sharing Access Criteria: The results will be published in a science citation indexed journal
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No