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Trial record 20 of 458 for:    DICLOFENAC

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
Sponsor:
Information provided by (Responsible Party):
Sulaiman Muhammaad Daneji, Bayero University Kano, Nigeria

Tracking Information
First Submitted Date  ICMJE September 25, 2016
First Posted Date  ICMJE September 29, 2016
Last Update Posted Date September 29, 2016
Study Start Date  ICMJE September 2016
Estimated Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 27, 2016)
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;
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 27, 2016)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intracervical Lidocaine Versus Intramuscular Diclofenac for Pain Relief in HSG in a Tertiary Hospital in Kano
Official Title  ICMJE 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
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Diagnostic
Condition  ICMJE Female Infertility of Tubal Origin
Intervention  ICMJE
  • Drug: Intracervical lidocaine
    Intracervical lidocaine injected at four different points
    Other Name: lignocaine
  • Drug: Intramuscular Diclofenac
    Intramuscular Diclofenac 30 mins before HSG
    Other Names:
    • Diclofenac sodium
    • Voltaren
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Intracervical lidocaine
  • Active Comparator: Intramuscular Diclofenac
    This group will comprise of patients that will receive intramuscular diclofenac potassium 75mg 30 minutes before proceeding with the hysterosalpingogram.
    Intervention: Drug: Intramuscular Diclofenac
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 27, 2016)
140
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2017
Estimated Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 49 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Nigeria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02918812
Other Study ID Numbers  ICMJE ONGDaneji1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Sulaiman Muhammaad Daneji, Bayero University Kano, Nigeria
Study Sponsor  ICMJE Bayero University Kano, Nigeria
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sulaiman D Muhammad, MBBS Aminu Kano Teaching Hospital
PRS Account Bayero University Kano, Nigeria
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP