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Transdermal Lidocaine for Pain Control During Hysterosalpingography

Sponsor
Aswan University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04518189
Collaborator
(none)
120
Enrollment
1
Location
2
Arms
12
Anticipated Duration (Months)
10
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

the study aims to investigate the effectiveness of Transdermal lidocaine patch for Pain Control During Hysterosalpingography

Condition or Disease Intervention/Treatment Phase
  • Drug: lidocaine patch
  • Drug: Sham patch
 N/A

Detailed Description

hysterosalpingography can cause pain and discomfort in several ways: Use of the tenaculum to grasp the cervix and straighten the uterus for proper insertion; trans-cervical actions including measuring uterine depth, inserting the cannula; and injection of the dye

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
double blind randomized trialdouble blind randomized trial
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
double blind randomized trial
Primary Purpose:
Prevention
Official Title:
Transdermal Lidocaine for Pain Control During Hysterosalpingography: A Randomized Controlled Trial
Actual Study Start Date :
Sep 1, 2020
Anticipated Primary Completion Date :
Jun 30, 2021
Anticipated Study Completion Date :
Aug 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: lidocaine patch

5% lidocaine patch applied at 3 hours before the procedure

Drug: lidocaine patch
lidocaine patch applied 3 hours before the procedure
Other Names:
  • Experimental

    		•
    Placebo Comparator: Sham patch

    Sham patch containing no study medication applied 3 hours before the procedure

    Drug: Sham patch
    Sham patch applied 3 hours before the procedure
    Other Names:
  • Placebo Comparator

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Mean pain score during the procedure [10 minutes]

      Assessment of pain using visual analog scale 0-10, 0 = minimum and 10 = maximum scores

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • any patient came for Hysterosalpingography
    Exclusion Criteria:
    • any patient has contraindication to Hysterosalpingography

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Aswan University Hospital Aswan Egypt 81528

    Sponsors and Collaborators

    • Aswan University Hospital

    Investigators

    • Study Chair: nahla w Shady, md, Aswan universirty

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    hany farouk, A Professor, Aswan University Hospital
    ClinicalTrials.gov Identifier:
    NCT04518189
    Other Study ID Numbers:
    • aswu/295/3/19
    First Posted:
    Aug 19, 2020
    Last Update Posted:
    Sep 21, 2020
    Last Verified:
    Sep 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Infertility
    Infertility, Female
    Lidocaine

    Study Results

    No Results Posted as of Sep 21, 2020