A Phase 4 interventional study of Intracervical lidocaine and Intramuscular Diclofenac in Female Infertility of Tubal Origin, sponsored by Bayero University Kano, Nigeria. Status unknown at 1 site in Nigeria. Open to female participants aged 18 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-09-29.
Sponsored by Bayero University Kano, Nigeria · Phase 4, Interventional, and Diagnostic
This study compares the effect of intracervical block with 1% lidocaine and intramuscular diclofenac 75mg in decreasing pain perception during hysterosalpingography. Half of participants will receive intracervical block with 1% lidocaine, while the other half will receive intramuscular diclofenac 75mg.
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
2,085 studies on the registry are indexed under Infertility; 357 are open to participants now.
This study's planned enrollment of 140 is close to the median of 135 across 1,412 interventional studies indexed under Infertility.
Browse Infertility studies →Bayero University Kano, Nigeria is the lead sponsor of 8 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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.
Drug: Intracervical lidocaine
This group will comprise of patients that will receive intramuscular diclofenac potassium 75mg 30 minutes before proceeding with the hysterosalpingogram.
Drug: Intramuscular Diclofenac
Intracervical lidocaine injected at four different points
Also known as: lignocaine
Intramuscular Diclofenac 30 mins before HSG
Also known as: Diclofenac sodium, Voltaren
Change in Visual Analogue Score
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;
Time frame: Preprocedure and procedure time 0
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
Change in pain score from pre-procedure to 5 and 30 minutes post procedure
Time frame: 5 minutes and 30 minutes
Change in pain score from pre-procedure to 5 and 24 hours post procedure
Time frame: 5 minutes and 24 hours
Plan to share: Undecided
This study is status unknown, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Lidocaine
Bayero University Kano, Nigeria