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

Female Infertility of Tubal Origin Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02918812
• Other study ID #: ONGDaneji1
• Status: Recruiting
• Phase: Phase 4
• First received: September 25, 2016
• Last updated: September 27, 2016
• Start date: September 2016
• Est. completion date: March 2017

Study information

• Verified date: September 2016
• Source: Bayer University Kano, Nigeria
• Contact: Sulaiman D Muhammad, MBBS
• Phone: +238065305050
• Email: smuhddane[@]yahoo.com
• Is FDA regulated: No
• Health authority: Nigeria: Federal Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: March 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Female Infertility of Tubal Origin
• Infertility
• Infertility, Female

Intervention

Drug:
• Intracervical lidocaine
Intracervical lidocaine injected at four different points
• Intramuscular Diclofenac
Intramuscular Diclofenac 30 mins before HSG

Locations

Country	Name	City	State
Nigeria	Aminu Kano Teaching Hospital	Kano	Kano State

Sponsors (1)

Lead Sponsor	Collaborator
Bayer University Kano, Nigeria

Country where clinical trial is conducted

Nigeria, 

References & Publications (8)

Ahmad G, Duffy J, Watson AJ. Pain relief in hysterosalpingography. Cochrane Database Syst Rev. 2007 Apr 18;(2):CD006106. Review. Update in: Cochrane Database Syst Rev. 2015;9:CD006106. — View Citation

Chauhan MB, Lakra P, Jyotsna D, Nanda S, Malhotra V. Pain relief during hysterosalpingography: role of intracervical block. Arch Gynecol Obstet. 2013 Jan;287(1):155-9. doi: 10.1007/s00404-012-2515-z. Epub 2012 Aug 28. — View Citation

Costello MF, Horrowitz S, Steigrad S, Saif N, Bennett M, Ekangaki A. Transcervical intrauterine topical local anesthetic at hysterosalpingography: a prospective, randomized, double-blind, placebo-controlled trial. Fertil Steril. 2002 Nov;78(5):1116-22. — View Citation

Hacivelioglu S, Gencer M, Cakir Gungor A, Kosar S, Koc E, Cosar E. Can the addition of a paracervical block to systemic or local analgesics improve the pain perceived by the patient during hysterosalpingography? J Obstet Gynaecol. 2014 Jan;34(1):48-53. doi: 10.3109/01443615.2013.828025. — View Citation

Hamilton M. Infertilty. In Edmonds K (Editor). Dewhurst's Textbook of obstetrics and gynecology. 8th edition. John Wiley and sons ltd 2012 567-79.

Robinson RD, Casablanca Y, Pagano KE, Arthur NA, Bates GW, Propst AM. Intracervical block and pain perception during the performance of a hysterosalpingogram: a randomized controlled trial. Obstet Gynecol. 2007 Jan;109(1):89-93. — View Citation

Simpson WL Jr, Beitia LG, Mester J. Hysterosalpingography: a reemerging study. Radiographics. 2006 Mar-Apr;26(2):419-31. Review. — View Citation

Sinnatamby CS editor. Last's Anatomy: Regional and Applied. 11th Edition. Edinburgh. Churchill Livingstone; 2006. P 311-6.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Visual Analogue Score	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;	Preprocedure and procedure time 0	No
Secondary	patient's satisfaction with pain relief in the two groups using Likert scale		Time Frame: 30 minutes post procedure and 24 hours post procedure	No
Secondary	Change in pain score from pre-procedure to 5 and 30 minutes post procedure		5 minutes and 30 minutes	No
Secondary	Change in pain score from pre-procedure to 5 and 24 hours post procedure		5 minutes and 24 hours	No