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

NCT03359655 | Completed DMC

• 1 other identifier: 2017-6-
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hysteroscopic Surgery; Pain, Postoperative

Keywords

misoprostol; hyoscine butyl bromide; cervical dilatation; cervical ripening; hysteroscopy; pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Analgesic administration

  Postoperative 2 hours

• Duration of procedure

  During the surgery

• Ease of cervical dilatation

  During the surgery

• Initial cervical dilatation

  During the surgery

Study Arms (3)

Rectal misoprostol

ACTIVE COMPARATOR

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 hyoscine butyl bromide

ACTIVE COMPARATOR

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

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

Interventions

Misoprostol DRUG

Rectal administration 2 jours before the procedure

Also known as: Cytotec

Rectal misoprostol

Hyoscine butyl bromide DRUG

Rectal administration 2 jours before the procedure

Also known as: Buscopan

Rectal hyoscine butyl bromide

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: Hysteroscopy is an endoscopic surgery for the uterus
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Reproductive aged women
• Women who are scheduled for hysteroscopy for indications of endometrial polyp, submucous myoma or synaechiae

You may not qualify if:

• Women who have undergone hysteroscopy previously
• women who are in menopause

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem Vakif University

Istanbul, 34093, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative; Pain

Interventions

Misoprostol; Butylscopolammonium Bromide

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Officials

• Serdar G Aydin

  Bezmialem Üniversitesi Tıp Fakültesi Hastanesi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blind masking
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Three group parallel design

Study Record Dates

• First Submitted: November 7, 2017
• First Posted: December 2, 2017
• Study Start: June 11, 2018
• Primary Completion: December 4, 2018
• Study Completion: December 13, 2018
• Last Updated: December 27, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: After the study is completed
• Access Criteria: The results will be published in a science citation indexed journal

Locations

TU (1)