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Topical Analgesia for Pain Relief in Hysterosalpingography (HSG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03802032
Recruitment Status : Completed
First Posted : January 14, 2019
Last Update Posted : August 18, 2020
Sponsor:
Information provided by (Responsible Party):
Anisah Yahya, Ahmadu Bello University Teaching Hospital

Brief Summary:
The study will involve giving topical analgesia or placebo and then assessing pain and satisfaction during and after the procedure in order to see wed to the placebo.hether the topical analgesia has helped in decreasing pain associated with the procedure and also whether it has increasedd satisfaction with the procedure compar

Condition or disease Intervention/treatment Phase
Infertility, Female Drug: Lidocaine Gel Drug: KY jelly Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A randomised controlled trial
Masking: Single (Care Provider)
Masking Description: Double blind
Primary Purpose: Treatment
Official Title: Effect of Topical Xylocaine for Pain Relief During Hysterosalpingography Among Infertile Women in Zaria, Nigeria: A Randomised Controlled Trial.
Actual Study Start Date : February 1, 2019
Actual Primary Completion Date : December 22, 2019
Actual Study Completion Date : December 22, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Study Group
15g of Topical Xylocaine gel
Drug: Lidocaine Gel
topical lidocaine gel

Placebo Comparator: Control group
15g of KY Jelly
Drug: KY jelly
topical KY jelly




Primary Outcome Measures :
  1. Pain perception [ Time Frame: witthin 45 minutes of the procedure ]

    The pain score based on visual pain scale that assesses pain perception. It is a scale of 0 to 10.

    0 = absence of pain.

    1. = discomfort
    2. = mild pain.
    3. = annoying pain.
    4. = nagging pain.
    5. = distressing pain.
    6. = miserable.
    7. = intense
    8. = Dreadful.
    9. = worse possible
    10. = unbearable


Secondary Outcome Measures :
  1. Patients Satisfaction with procedure [ Time Frame: witthin 45 minutes of the procedure ]

    Satisfaction with the procedure based on Likert scale. The scale is from 1 to 5.

    1. = Very dissatisfied.
    2. = Dissatisfied..
    3. = Neither satisfied nor dissatisfied.
    4. = Satisfied.
    5. = Very satisfied.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   based on biological gender
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All women that are sent in to the department of radiology for Hysterosalpingogram as part of evaluation for infertility that give consent.

Exclusion Criteria:

  • Women that present for hysterosalpingography for other indications apart from infertility and those that have history of allergy to xylocaine and/or K-Y jelly.

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): NCT03802032


Locations
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Nigeria
Ahmadu Bello University Teaching Hospital Shika-Zaria
Zaria, Kaduna, Nigeria, PMB 06
Sponsors and Collaborators
Ahmadu Bello University Teaching Hospital
Investigators
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Principal Investigator: Anisah Yahya, MBBS Ahmadu Bello University Zaria
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Responsible Party: Anisah Yahya, Doctor, Ahmadu Bello University Teaching Hospital
ClinicalTrials.gov Identifier: NCT03802032    
Other Study ID Numbers: Ahmadu Bello University
First Posted: January 14, 2019    Key Record Dates
Last Update Posted: August 18, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: obtained data and result will be shared
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
Time Frame: within 6 months of completion
Access Criteria: free

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anisah Yahya, Ahmadu Bello University Teaching Hospital:
infertility
hysterosalpingography
pain
Additional relevant MeSH terms:
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Infertility
Infertility, 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