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Trial record 20 of 460 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

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.

Condition or disease Intervention/treatment Phase
Female Infertility of Tubal Origin Drug: Intracervical lidocaine Drug: Intramuscular Diclofenac Phase 4

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Diagnostic
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 Start Date : September 2016
Estimated Primary Completion Date : February 2017
Estimated Study Completion Date : March 2017


Arm Intervention/treatment
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.
Drug: Intracervical lidocaine
Intracervical lidocaine injected at four different points
Other Name: lignocaine

Active Comparator: Intramuscular Diclofenac
This group will comprise of patients that will receive intramuscular diclofenac potassium 75mg 30 minutes before proceeding with the hysterosalpingogram.
Drug: Intramuscular Diclofenac
Intramuscular Diclofenac 30 mins before HSG
Other Names:
  • Diclofenac sodium
  • Voltaren




Primary Outcome Measures :
  1. 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;


Secondary Outcome Measures :
  1. 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 ]
  2. Change in pain score from pre-procedure to 5 and 30 minutes post procedure [ Time Frame: 5 minutes and 30 minutes ]
  3. Change in pain score from pre-procedure to 5 and 24 hours post procedure [ Time Frame: 5 minutes and 24 hours ]


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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02918812


Contacts
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Contact: Sulaiman D Muhammad, MBBS +238065305050 smuhddane@yahoo.com

Locations
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Nigeria
Aminu Kano Teaching Hospital Recruiting
Kano, Kano State, Nigeria
Contact: Sulaiman D Muhammad, MBBS    +2348065305050      
Principal Investigator: Sulaiman D Muhammad, MBBS         
Sponsors and Collaborators
Bayero University Kano, Nigeria
Investigators
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Principal Investigator: Sulaiman D Muhammad, MBBS Aminu Kano Teaching Hospital

Publications:
Hamilton M. Infertilty. In Edmonds K (Editor). Dewhurst's Textbook of obstetrics and gynecology. 8th edition. John Wiley and sons ltd 2012 567-79.
Sinnatamby CS editor. Last's Anatomy: Regional and Applied. 11th Edition. Edinburgh. Churchill Livingstone; 2006. P 311-6.

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Responsible Party: Sulaiman Muhammaad Daneji, Student, Bayero University Kano, Nigeria
ClinicalTrials.gov Identifier: NCT02918812     History of Changes
Other Study ID Numbers: ONGDaneji1
First Posted: September 29, 2016    Key Record Dates
Last Update Posted: September 29, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Sulaiman Muhammaad Daneji, Bayero University Kano, Nigeria:
Hysterosalpingography
Pain relief
Infertility
Intracervical block
Diclofenac
Additional relevant MeSH terms:
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Diclofenac
Infertility
Infertility, Female
Genital Diseases, Male
Genital Diseases, Female
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors