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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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10 October 2016 |
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Main ID: |
NCT02918812 |
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Date of registration:
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25/09/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Intracervical Lidocaine Versus Intramuscular Diclofenac for Pain Relief in HSG in a Tertiary Hospital in Kano
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Scientific title:
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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 |
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Date of first enrolment:
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September 2016 |
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Target sample size:
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140 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02918812 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Diagnostic
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Phase:
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Phase 4
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Countries of recruitment
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Nigeria
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Contacts
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Name:
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Sulaiman D Muhammad, MBBS |
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Address:
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Telephone:
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Email:
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Affiliation:
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Aminu Kano Teaching Hospital |
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Name:
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Sulaiman D Muhammad, MBBS |
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Address:
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Telephone:
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+2348065305050 |
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Email:
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Affiliation:
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Name:
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Sulaiman D Muhammad, MBBS |
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Address:
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Telephone:
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+238065305050 |
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Email:
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smuhddane@yahoo.com |
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Affiliation:
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
49 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Female Infertility of Tubal Origin
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Intervention(s)
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Drug: Intramuscular Diclofenac
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Drug: Intracervical lidocaine
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Primary Outcome(s)
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Change in Visual Analogue Score
[Time Frame: Preprocedure and procedure time 0]
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Secondary Outcome(s)
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patient's satisfaction with pain relief in the two groups using Likert scale
[Time Frame: 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 24 hours post procedure
[Time Frame: 5 minutes and 24 hours]
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Change in pain score from pre-procedure to 5 and 30 minutes post procedure
[Time Frame: 5 minutes and 30 minutes]
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Secondary ID(s)
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ONGDaneji1
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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