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

Bayero University Kano, Nigeria

Status and phase: Unknown; Phase 4

Conditions: Female Infertility of Tubal Origin

Treatments: Drug: Intramuscular Diclofenac; Drug: Intracervical lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT02918812

ONGDaneji1

Details and patient eligibility

About

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.

Full 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

Enrollment: 140 estimated patients

Sex: Female

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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140 participants in 2 patient groups

Intracervical lidocaine

Experimental group

Description:

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.

Treatment:

Drug: Intracervical lidocaine

Intramuscular Diclofenac

Active Comparator group

Description:

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

Treatment:

Drug: Intramuscular Diclofenac