Clinical trial NCT02918812: Intracervical Lidocaine Versus Intramuscular Diclofenac for Pain Relief in HSG in a Tertiary Hospital in Kano
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Female Infertility of Tubal Origin
Keywords: Hysterosalpingography
Pain relief
Infertility
Intracervical block
Diclofenac
Lead sponsor: Bayero University Kano, Nigeria
Sponsor class: OTHER
First posted: 2016-09-29
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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

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

Primary outcomes:
measure: Change in Visual Analogue Score
timeFrame: Preprocedure and procedure time 0
Secondary outcomes:
measure: patient's satisfaction with pain relief in the two groups using Likert scale
timeFrame: Time Frame: 30 minutes post procedure and 24 hours post procedure
measure: Change in pain score from pre-procedure to 5 and 30 minutes post procedure
timeFrame: 5 minutes and 30 minutes
measure: Change in pain score from pre-procedure to 5 and 24 hours post procedure
timeFrame: 5 minutes and 24 hours
Other outcomes:
Locations:
city: Kano
country: Nigeria
facility: Aminu Kano Teaching Hospital
state: Kano State
Study officials:
affiliation: Aminu Kano Teaching Hospital
name: Sulaiman D Muhammad, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
citation: 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. doi: 10.1097/01.AOG.0000247645.52211.41.
citation: Ahmad G, Duffy J, Watson AJ. Pain relief in hysterosalpingography. Cochrane Database Syst Rev. 2007 Apr 18;(2):CD006106. doi: 10.1002/14651858.CD006106.pub2.
citation: Sinnatamby CS editor. Last's Anatomy: Regional and Applied. 11th Edition. Edinburgh. Churchill Livingstone; 2006. P 311-6.
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. doi: 10.1016/s0015-0282(02)03362-9.
citation: Simpson WL Jr, Beitia LG, Mester J. Hysterosalpingography: a reemerging study. Radiographics. 2006 Mar-Apr;26(2):419-31. doi: 10.1148/rg.262055109.