- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02918812
Intracervical Lidocaine Versus Intramuscular Diclofenac for Pain Relief in HSG in a Tertiary Hospital in Kano
The Effect of Intracervical Lidocaine Versus Intramuscular Diclofenac for Pain Relief During Hysterosalpingography Among Infertile Women In A Tertiary Hospital In Kano: A Randomized Controlled Trial
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Hysterosalpingography (HSG) is a radiographic test to evaluate the contour of the uterine cavity and patency of the fallopian tubes after injection of a radio-opaque dye through the cervix. It is typically performed in the evaluation of infertility or to diagnose uterine anomalies. It is the most common method of tubal evaluation in the developing countries because it is cheap, readily available and requires less expertise. Unfortunately, HSG can cause discomfort or pain for the patient during or after the procedure, and this evokes anxiety and fear for many patients. Up to 72 % of women complain of significant discomfort with this test.
Lidocaine is a local anaesthetic which exerts its effect by altering neuronal depolarization by blocking the sodium channels in the cell membrane, thereby preventing transmission of the sensation of pain to the higher neurons. Lidocaine is commonly used for infiltration and for peripheral nerve blocks if an intermediate duration is required.
Diclofenac is a Non-steroidal anti inflammatory drug that reduce nociception which is related to inflammation and inflammatory mediators whether from trauma
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Fase 4
Kontakter og lokationer
Studiekontakt
- Navn: Sulaiman D Muhammad, MBBS
- Telefonnummer: +238065305050
- E-mail: smuhddane@yahoo.com
Studiesteder
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Kano State
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Kano, Kano State, Nigeria
- Rekruttering
- Aminu Kano Teaching Hospital
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Kontakt:
- Sulaiman D Muhammad, MBBS
- Telefonnummer: +2348065305050
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Ledende efterforsker:
- Sulaiman D Muhammad, MBBS
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- All women with infertility who will be undergoing a hysterosalpingography, and must have given consent will be recruited into the study
Exclusion Criteria:
- History of any allergies to local anaesthetics, radio-opaque dye, or anti-inflammatory medications
- All patients with active pelvic inflammatory diseases
- All patients with chronic pelvic pain
- Patients with history of cervical surgery
- Other indications for hysterosalpingography like Ashermans syndrome, congenital uterine anomalies
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Intracervical lidocaine
This group will comprise of patients that will receive the intracervical block.
The study group will receive a total of 60 mg (6 mL) of 1% lidocaine to be injected at four points (12, 4, 6, and 8 o'clock) circumferentially into the cervix (1.5 mL at each point) 5 minutes before proceeding with the hysterosalpingogram.
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Intracervical lidocaine injected at four different points
Andre navne:
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Aktiv komparator: Intramuscular Diclofenac
This group will comprise of patients that will receive intramuscular diclofenac potassium 75mg 30 minutes before proceeding with the hysterosalpingogram.
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Intramuscular Diclofenac 30 mins before HSG
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Change in Visual Analogue Score
Tidsramme: Preprocedure and procedure time 0
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A detailed description of the visual analogue scale (VAS) will be given personally to each woman prior to the procedure.
The VAS included a 10 cm linear scale on which 0 represents 'no pain' and 10 represents 'worst pain imaginable'.
All patients will be asked to grade their perceived lower abdominal pain levels during specified stages of HSG using the VAS as explained to them.
The scale will be used at different stages of the procedure: (1) before beginning the procedure; (2) after speculum application but before instrumentation; (3) after the application of the tenaculum and metal cannula and just before the injection of contrast medium; (4) at the end of uterine filling with contrast medium;
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Preprocedure and procedure time 0
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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patient's satisfaction with pain relief in the two groups using Likert scale
Tidsramme: Time Frame: 30 minutes post procedure and 24 hours post procedure
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Time Frame: 30 minutes post procedure and 24 hours post procedure
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Change in pain score from pre-procedure to 5 and 30 minutes post procedure
Tidsramme: 5 minutes and 30 minutes
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5 minutes and 30 minutes
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Change in pain score from pre-procedure to 5 and 24 hours post procedure
Tidsramme: 5 minutes and 24 hours
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5 minutes and 24 hours
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Sulaiman D Muhammad, MBBS, Aminu Kano Teaching Hospital
Publikationer og nyttige links
Generelle publikationer
- Costello MF, Horrowitz S, Steigrad S, Saif N, Bennett M, Ekangaki A. Transcervical intrauterine topical local anesthetic at hysterosalpingography: a prospective, randomized, double-blind, placebo-controlled trial. Fertil Steril. 2002 Nov;78(5):1116-22. doi: 10.1016/s0015-0282(02)03362-9.
- Hamilton M. Infertilty. In Edmonds K (Editor). Dewhurst's Textbook of obstetrics and gynecology. 8th edition. John Wiley and sons ltd 2012 567-79.
- Hacivelioglu S, Gencer M, Cakir Gungor A, Kosar S, Koc E, Cosar E. Can the addition of a paracervical block to systemic or local analgesics improve the pain perceived by the patient during hysterosalpingography? J Obstet Gynaecol. 2014 Jan;34(1):48-53. doi: 10.3109/01443615.2013.828025.
- Chauhan MB, Lakra P, Jyotsna D, Nanda S, Malhotra V. Pain relief during hysterosalpingography: role of intracervical block. Arch Gynecol Obstet. 2013 Jan;287(1):155-9. doi: 10.1007/s00404-012-2515-z. Epub 2012 Aug 28.
- Robinson RD, Casablanca Y, Pagano KE, Arthur NA, Bates GW, Propst AM. Intracervical block and pain perception during the performance of a hysterosalpingogram: a randomized controlled trial. Obstet Gynecol. 2007 Jan;109(1):89-93. doi: 10.1097/01.AOG.0000247645.52211.41.
- Ahmad G, Duffy J, Watson AJ. Pain relief in hysterosalpingography. Cochrane Database Syst Rev. 2007 Apr 18;(2):CD006106. doi: 10.1002/14651858.CD006106.pub2.
- Sinnatamby CS editor. Last's Anatomy: Regional and Applied. 11th Edition. Edinburgh. Churchill Livingstone; 2006. P 311-6.
- Simpson WL Jr, Beitia LG, Mester J. Hysterosalpingography: a reemerging study. Radiographics. 2006 Mar-Apr;26(2):419-31. doi: 10.1148/rg.262055109.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Infertilitet
- Infertilitet, kvinde
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Anti-arytmimidler
- Depressive midler til centralnervesystemet
- Agenter fra det perifere nervesystem
- Enzymhæmmere
- Analgetika
- Sensoriske systemagenter
- Bedøvelsesmidler
- Anti-inflammatoriske midler, ikke-steroide
- Analgetika, ikke-narkotisk
- Anti-inflammatoriske midler
- Antirheumatiske midler
- Cyclooxygenase-hæmmere
- Membrantransportmodulatorer
- Bedøvelsesmidler, lokale
- Spændingsstyret natriumkanalblokkere
- Natriumkanalblokkere
- Lidokain
- Diclofenac
Andre undersøgelses-id-numre
- ONGDaneji1
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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