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
Overview
- Phase
- Phase 4
- Intervention
- Intracervical lidocaine
- Conditions
- Female Infertility of Tubal Origin
- Sponsor
- Bayero University Kano, Nigeria
- Enrollment
- 140
- Locations
- 1
- Primary Endpoint
- Change in Visual Analogue Score
- Last Updated
- 9 years ago
Overview
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
Investigators
Sulaiman Muhammaad Daneji
Student
Bayero University Kano, Nigeria
Eligibility Criteria
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
Arms & Interventions
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.
Intervention: Intracervical lidocaine
Intramuscular Diclofenac
This group will comprise of patients that will receive intramuscular diclofenac potassium 75mg 30 minutes before proceeding with the hysterosalpingogram.
Intervention: Intramuscular Diclofenac
Outcomes
Primary Outcomes
Change in Visual Analogue Score
Time Frame: 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 Outcomes
- 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)