Intracervical Lidocaine Versus Intramuscular Diclofenac for Pain Relief in HSG in a Tertiary Hospital in Kano

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official 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

Conditions
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Female Infertility of Tubal Origin

Intervention / Treatment
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* Drug: Intracervical lidocaine
* Drug: Intramuscular Diclofenac


Participation Criteria
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Eligibility 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intracervical lidocaine<br>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<br>* Intracervical lidocaine injected at four different points<br>* Other names: lignocaine;|
| Active Comparator: Intramuscular Diclofenac<br>This group will comprise of patients that will receive intramuscular diclofenac potassium 75mg 30 minutes before proceeding with the hysterosalpingogram. | Drug: Intramuscular Diclofenac<br>* Intramuscular Diclofenac 30 mins before HSG<br>* Other names: Voltaren;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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; | Preprocedure and procedure time 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient's satisfaction with pain relief in the two groups using Likert scale |  | 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 |  | 5 minutes and 30 minutes | 
| Change in pain score from pre-procedure to 5 and 24 hours post procedure |  | 5 minutes and 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain relief, Hysterosalpingography, Infertility, Intracervical block, Diclofenac