Intracervical Lidocaine Versus Intramuscular Diclofenac for Pain Relief in HSG in a Tertiary Hospital in Kano
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|ClinicalTrials.gov Identifier: NCT02918812|
Recruitment Status : Unknown
Verified September 2016 by Sulaiman Muhammaad Daneji, Bayero University Kano, Nigeria.
Recruitment status was: Recruiting
First Posted : September 29, 2016
Last Update Posted : September 29, 2016
|Condition or disease||Intervention/treatment||Phase|
|Female Infertility of Tubal Origin||Drug: Intracervical lidocaine Drug: Intramuscular Diclofenac||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|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 :||September 2016|
|Estimated Primary Completion Date :||February 2017|
|Estimated Study Completion Date :||March 2017|
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 Name: 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
- 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;
- patient's satisfaction with pain relief in the two groups using Likert scale [ Time Frame: 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 [ Time Frame: 5 minutes and 30 minutes ]
- Change in pain score from pre-procedure to 5 and 24 hours post procedure [ Time Frame: 5 minutes and 24 hours ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02918812
|Contact: Sulaiman D Muhammad, MBBSfirstname.lastname@example.org|
|Aminu Kano Teaching Hospital||Recruiting|
|Kano, Kano State, Nigeria|
|Contact: Sulaiman D Muhammad, MBBS +2348065305050|
|Principal Investigator: Sulaiman D Muhammad, MBBS|
|Principal Investigator:||Sulaiman D Muhammad, MBBS||Aminu Kano Teaching Hospital|