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The Value of Endocervical and Endometrial Lidocaine Flushing Before Office Hystroscopy

18. maj 2018 opdateret af: Ahmed Maged, Cairo University
women candidate for office hystroscopy were randomized to either flushing of the endocervix and endometrium with 4 ml lidocaine 2% diluted in 15 ml normal saline or 19 ml normal saline before office hystroscopy

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Patients were asked to urinate to evacuate the bladder. Posterior vaginal retractor was introduced to expose the cervix and ( embryo transfer catheter was introduced throught the cervix passing the internal os and intrauterine and intracervical instillation of to either flushing of the endocervix and endometrium with 4 ml lidocaine 2% diluted in 15 ml normal saline or 19 ml normal saline.

After 5 mins the procedure was started A rigid 3.5 mm hystroscope with an optic of 30 degrees was used. Normal saline solution was used as distension media, with 120 mmHg intrauterine pressure, Vaginoscopic approach, nocervical tenaculum or dilators used.

Post procedure pain management by optional dose of 75 mg of diclofenac potassium when requested.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

250

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Egypten
      • Cairo, Egypten, 12111
        • Kasr Alainy Medical School

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

20 år til 45 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria:

  • all women indicated for office hysteroscopy for evaluation of the uterine cavity eg: AUB, infertility

Exclusion Criteria:

  • Women allergic to local anesthesia those required operative hysteroscopy under general anesthesia pelvic inflammatory disease known cervical malignancy profuse uterine bleeding, marked cervical stenosis recent uterine perforation previous cervical surgery and neurological disorders affecting evaluation of pain using other products that could affect the consistency of the cervix such as local estrogen, misoprostol or laminaire are contraindications for office hystroscopy

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Lidocaine group
intrauterine and intracervical instillation of 4 ml of lidocaine 2% diluted in 15 ml normal saline 5 minutes before hystroscopy
Medicin: Lidocaine
intrauterine and intracervical instillation of 4 ml of lidocaine 2% diluted in 15 ml normal saline
Procedure: Office hystroscopy
A rigid 3.5 mm hystroscope with an optic of 30 degrees was used. Normal saline solution was used as distension media, with 120 mmHg intrauterine pressure, Vaginoscopic approach, nocervical tenaculum or dilators used.
Placebo komparator: control group
intrauterine and intracervical instillation of 19 ml normal saline 5 minutes before hystroscopy
Procedure: Office hystroscopy
A rigid 3.5 mm hystroscope with an optic of 30 degrees was used. Normal saline solution was used as distension media, with 120 mmHg intrauterine pressure, Vaginoscopic approach, nocervical tenaculum or dilators used.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pain assessment during the hysteroscopy
Tidsramme: during hystroscopy procedure
pain assessment during hystroscopy using visual analogue scale VAS. is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100
during hystroscopy procedure

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pain assessment 10 minutes after hysteroscopy
Tidsramme: 10 minutes after hysteroscopy
pain assessment 10 minutes after hystroscopy using visual analogue scale VAS. is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100
10 minutes after hysteroscopy
Pain assessment 30 minutes after hysteroscopy
Tidsramme: 30 minutes after hysteroscopy
pain assessment 30 minutes after hystroscopy using visual analogue scale VAS. is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100
30 minutes after hysteroscopy
Pain assessment 60 minutes after hysteroscopy
Tidsramme: 60 minutes after hysteroscopy
pain assessment 60 minutes after hystroscopy using visual analogue scale VAS. is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100
60 minutes after hysteroscopy

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Cairo University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Forventet)

1. maj 2018

Primær færdiggørelse (Forventet)

1. december 2018

Studieafslutning (Forventet)

1. december 2018

Datoer for studieregistrering

Først indsendt

8. maj 2018

Først indsendt, der opfyldte QC-kriterier

18. maj 2018

Først opslået (Faktiske)

21. maj 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

21. maj 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. maj 2018

Sidst verificeret

1. maj 2018

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 36

Plan for individuelle deltagerdata (IPD)

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UBESLUTET

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med Pain During Hystroscopy

Kliniske forsøg med Lidocaine

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

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Betingelser

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