search
Back to results

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

Primary Purpose

Female Infertility of Tubal Origin

Status
Unknown status
Phase
Phase 4
Locations
Nigeria
Study Type
Interventional
Intervention
Intracervical lidocaine
Intramuscular Diclofenac
Sponsored by
Bayero University Kano, Nigeria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Female Infertility of Tubal Origin focused on measuring Hysterosalpingography, Pain relief, Infertility, Intracervical block, Diclofenac

Eligibility Criteria

18 Years - 49 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Aminu Kano Teaching HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intracervical lidocaine

Intramuscular Diclofenac

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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;

Secondary Outcome Measures

patient's satisfaction with pain relief in the two groups using Likert scale
Change in pain score from pre-procedure to 5 and 30 minutes post procedure
Change in pain score from pre-procedure to 5 and 24 hours post procedure

Full Information

First Posted
September 25, 2016
Last Updated
September 27, 2016
Sponsor
Bayero University Kano, Nigeria
search

1. Study Identification

Unique Protocol Identification Number
NCT02918812
Brief Title
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

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2016 (undefined)
Primary Completion Date
February 2017 (Anticipated)
Study Completion Date
March 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bayero University Kano, Nigeria

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Female Infertility of Tubal Origin
Keywords
Hysterosalpingography, Pain relief, Infertility, Intracervical block, Diclofenac

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intracervical lidocaine
Arm Type
Experimental
Arm Description
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.
Arm Title
Intramuscular Diclofenac
Arm Type
Active Comparator
Arm Description
This group will comprise of patients that will receive intramuscular diclofenac potassium 75mg 30 minutes before proceeding with the hysterosalpingogram.
Intervention Type
Drug
Intervention Name(s)
Intracervical lidocaine
Other Intervention Name(s)
lignocaine
Intervention Description
Intracervical lidocaine injected at four different points
Intervention Type
Drug
Intervention Name(s)
Intramuscular Diclofenac
Other Intervention Name(s)
Diclofenac sodium, Voltaren
Intervention Description
Intramuscular Diclofenac 30 mins before HSG
Primary Outcome Measure Information:
Title
Change in Visual Analogue Score
Description
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;
Time Frame
Preprocedure and procedure time 0
Secondary Outcome Measure Information:
Title
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
Title
Change in pain score from pre-procedure to 5 and 30 minutes post procedure
Time Frame
5 minutes and 30 minutes
Title
Change in pain score from pre-procedure to 5 and 24 hours post procedure
Time Frame
5 minutes and 24 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sulaiman D Muhammad, MBBS
Phone
+238065305050
Email
smuhddane@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sulaiman D Muhammad, MBBS
Organizational Affiliation
Aminu Kano Teaching Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aminu Kano Teaching Hospital
City
Kano
State/Province
Kano State
Country
Nigeria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sulaiman D Muhammad, MBBS
Phone
+2348065305050
First Name & Middle Initial & Last Name & Degree
Sulaiman D Muhammad, MBBS

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
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.
Results Reference
background
PubMed Identifier
24359050
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.
Results Reference
background
PubMed Identifier
22926800
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.
Results Reference
background
PubMed Identifier
17197592
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.
Results Reference
background
PubMed Identifier
17443612
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.
Results Reference
background
Citation
Sinnatamby CS editor. Last's Anatomy: Regional and Applied. 11th Edition. Edinburgh. Churchill Livingstone; 2006. P 311-6.
Results Reference
background
PubMed Identifier
12414003
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.
Results Reference
background
PubMed Identifier
16549607
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs