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

NCT02918812 | Unknown Phase 4

• 1 other identifier: ONGDaneji1
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Female Infertility of Tubal Origin

Keywords

Hysterosalpingography; Pain relief; Infertility; Intracervical block; Diclofenac

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• patient's satisfaction with pain relief in the two groups using Likert scale

  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

  5 minutes and 30 minutes

• Change in pain score from pre-procedure to 5 and 24 hours post procedure

  5 minutes and 24 hours

Study Arms (2)

Intracervical lidocaine

EXPERIMENTAL

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

Intramuscular Diclofenac

ACTIVE COMPARATOR

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

Drug: Intramuscular Diclofenac

Interventions

Intracervical lidocaine DRUG

Intracervical lidocaine injected at four different points

Also known as: lignocaine

Intracervical lidocaine

Intramuscular Diclofenac DRUG

Intramuscular Diclofenac 30 mins before HSG

Also known as: Diclofenac sodium, Voltaren

Intramuscular Diclofenac

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• All women with infertility who will be undergoing a hysterosalpingography, and must have given consent will be recruited into the study

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayero University Kano, Nigeria: lead

Study Sites (1)

Aminu Kano Teaching Hospital

Kano, Kano State, Nigeria

RECRUITING

Related Publications (8)

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

  BACKGROUND

• 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.

  PMID: 24359050 BACKGROUND

• 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.

  PMID: 22926800 BACKGROUND

• 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.

  PMID: 17197592 BACKGROUND

• 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.

  PMID: 17443612 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 12414003 BACKGROUND

• Simpson WL Jr, Beitia LG, Mester J. Hysterosalpingography: a reemerging study. Radiographics. 2006 Mar-Apr;26(2):419-31. doi: 10.1148/rg.262055109.

  PMID: 16549607 BACKGROUND

MeSH Terms

Conditions

Infertility

Interventions

Lidocaine; Diclofenac

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids

Study Officials

• Sulaiman D Muhammad, MBBS

  Aminu Kano Teaching Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sulaiman D Muhammad, MBBS

CONTACT

+238065305050; smuhddane@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Student

Study Record Dates

• First Submitted: September 25, 2016
• First Posted: September 29, 2016
• Study Start: September 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: March 1, 2017
• Last Updated: September 29, 2016

Record last verified: 2016-09

Locations

NG (1)