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Transdermal Lidocaine for Pain Control During Hysterosalpingography

Primary Purpose

Infertility, Female

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
lidocaine patch
Sham patch
Sponsored by
Aswan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Infertility, Female

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • any patient came for Hysterosalpingography

Exclusion Criteria:

  • any patient has contraindication to Hysterosalpingography

Sites / Locations

  • Aswan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

lidocaine patch

Sham patch

Arm Description

5% lidocaine patch applied at 3 hours before the procedure

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

Outcomes

Primary Outcome Measures

Mean pain score during the procedure
Assessment of pain using visual analog scale 0-10, 0 = minimum and 10 = maximum scores

Secondary Outcome Measures

Full Information

First Posted
August 15, 2020
Last Updated
September 18, 2020
Sponsor
Aswan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04518189
Brief Title
Transdermal Lidocaine for Pain Control During Hysterosalpingography
Official Title
Transdermal Lidocaine for Pain Control During Hysterosalpingography: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
June 30, 2021 (Anticipated)
Study Completion Date
August 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aswan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Female

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
double blind randomized trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
double blind randomized trial
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
lidocaine patch
Arm Type
Experimental
Arm Description
5% lidocaine patch applied at 3 hours before the procedure
Arm Title
Sham patch
Arm Type
Placebo Comparator
Arm Description
Sham patch containing no study medication applied 3 hours before the procedure
Intervention Type
Drug
Intervention Name(s)
lidocaine patch
Other Intervention Name(s)
Experimental
Intervention Description
lidocaine patch applied 3 hours before the procedure
Intervention Type
Drug
Intervention Name(s)
Sham patch
Other Intervention Name(s)
Placebo Comparator
Intervention Description
Sham patch applied 3 hours before the procedure
Primary Outcome Measure Information:
Title
Mean pain score during the procedure
Description
Assessment of pain using visual analog scale 0-10, 0 = minimum and 10 = maximum scores
Time Frame
10 minutes

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
any patient came for Hysterosalpingography
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: any patient came for Hysterosalpingography Exclusion Criteria: any patient has contraindication to Hysterosalpingography
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
hany f Sallam, md
Phone
+20102435461
Ext
002
Email
hany.farouk@aswu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
nahla w Shady, md
Phone
+201022336052
Ext
002
Email
hanygyne@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
nahla w Shady, md
Organizational Affiliation
Aswan universirty
Official's Role
Study Chair
Facility Information:
Facility Name
Aswan University Hospital
City
Aswan
ZIP/Postal Code
81528
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hany F Sallam, MD
Phone
0122336052
Ext
002
Email
hany.farouk@aswu.edu.eg
First Name & Middle Initial & Last Name & Degree
Nahla W Shady, MD
Phone
01092440504
Ext
002
Email
nahla.elsayed@aswu.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Transdermal Lidocaine for Pain Control During Hysterosalpingography

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