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

Sponsor

Bayero University Kano, Nigeria (Other)

Overall Status

Unknown status

CT.gov ID

NCT02918812

Collaborator

(none)

140

Enrollment

Location

Arms

5.9

Duration (Months)

23.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Female Infertility of Tubal Origin	Drug: Intracervical lidocaine Drug: Intramuscular Diclofenac	Phase 4

Detailed Description

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

140 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Sep 1, 2016

Anticipated Primary Completion Date :

Feb 1, 2017

Anticipated Study Completion Date :

Mar 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: Intracervical lidocaine Intracervical lidocaine injected at four different points Other Names: lignocaine
Active Comparator: Intramuscular Diclofenac This group will comprise of patients that will receive intramuscular diclofenac potassium 75mg 30 minutes before proceeding with the hysterosalpingogram.	Drug: Intramuscular Diclofenac Intramuscular Diclofenac 30 mins before HSG Other Names: Diclofenac sodium Voltaren

Arm

Intervention/Treatment

Experimental: 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.

Drug: Intracervical lidocaine

Intracervical lidocaine injected at four different points

Other Names:

lignocaine

Active Comparator: Intramuscular Diclofenac

This group will comprise of patients that will receive intramuscular diclofenac potassium 75mg 30 minutes before proceeding with the hysterosalpingogram.

Drug: Intramuscular Diclofenac

Intramuscular Diclofenac 30 mins before HSG

Other Names:

Diclofenac sodium

Voltaren

Outcome Measures

Primary Outcome Measures

Change in Visual Analogue Score [Preprocedure and procedure time 0]
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;

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 49 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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