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

Phase 4

• Conditions: Female Infertility of Tubal Origin
• Interventions: Drug: Intracervical lidocaine; Drug: Intramuscular Diclofenac

• Registration Number: NCT02918812
• Lead Sponsor: Bayero University Kano, Nigeria

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.

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 Timeline

• Status Verified: 2016-09
• Study Start: 2016-09
• Study First Submitted: 2016-09-25
• Study First Submitted QC: 2016-09-27
• Last Update Submitted: 2016-09-27
• Study First Posted: 2016-09-29
• Last Update Posted: 2016-09-29
• Primary Completion: 2017-02
• Study Completion: 2017-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intracervical lidocaine	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.
Intramuscular Diclofenac	Intramuscular Diclofenac	This group will comprise of patients that will receive intramuscular diclofenac potassium 75mg 30 minutes before proceeding with the hysterosalpingogram.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
patient's satisfaction with pain relief in the two groups using Likert scale	Time Frame: 30 minutes post procedure and 24 hours post procedure

Trial Locations

Locations (1)

Aminu Kano Teaching Hospital; 🇳🇬 Kano, Kano State, Nigeria