Back to resultsTransdermal Lidocaine for Pain Control During Diagnostic Office Hysteroscopy
Primary Purpose
Infertility, Female
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
lidocaine patch
Sham patch
Sponsored by
About this trial
This is an interventional prevention trial for Infertility, Female
Eligibility Criteria
Inclusion Criteria:
- patients with an indication for office hysteroscopy
Exclusion Criteria:
- patient refuse to participant
- contraindication for lidocaine patch
Sites / Locations
- Aswan University Hospital
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 6 hours before the scheduled office hysteroscopy.
Sham patch applied at 6 hours before the scheduled office hysteroscopy.
Outcomes
Primary Outcome Measures
Pain intensity will be assessed by visual analogue scale
Pain intensity will be assessed by visual analogue scale 30 minutes after the procedure. Visual analogue scale ranging from 0 to 10
Secondary Outcome Measures
Operative time
From the introduction of hysteroscope into the vagina till compilation of hysteroscopic examination
Full Information
NCT ID
NCT04518202
First Posted
August 15, 2020
Last Updated
August 15, 2020
Sponsor
Aswan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04518202
Brief Title
Transdermal Lidocaine for Pain Control During Diagnostic Office Hysteroscopy
Official Title
Transdermal Lidocaine for Pain Control During Diagnostic Office Hysteroscopy: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2020 (Anticipated)
Primary Completion Date
August 31, 2021 (Anticipated)
Study Completion Date
September 30, 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
To compare the effectiveness of Transdermal Lidocaine for Pain Control During Diagnostic Office Hysteroscopy
Detailed Description
hysteroscopy is commonly used in the diagnosis and treatment of intrauterine lesions such as polyps, fibroids, septa, and adhesions, and in the presence of abnormal bleeding and during the removal of an intrauterine device or foreign body. Cervical ripening is made possible by the use of medication through different routes.
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 blinded randomized controlled trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
double blinded randomized controlled trial
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
lidocaine patch
Arm Type
Experimental
Arm Description
5% lidocaine patch applied at 6 hours before the scheduled office hysteroscopy.
Arm Title
Sham patch
Arm Type
Placebo Comparator
Arm Description
Sham patch applied at 6 hours before the scheduled office hysteroscopy.
Intervention Type
Drug
Intervention Name(s)
lidocaine patch
Other Intervention Name(s)
Experimental
Intervention Description
5% lidocaine patch applied at 6 hours before the scheduled office hysteroscopy.
Intervention Type
Drug
Intervention Name(s)
Sham patch
Other Intervention Name(s)
Placebo Comparator
Intervention Description
Sham patch containing no study medication applied at 6 hours before the scheduled office hysteroscopy.
Primary Outcome Measure Information:
Title
Pain intensity will be assessed by visual analogue scale
Description
Pain intensity will be assessed by visual analogue scale 30 minutes after the procedure. Visual analogue scale ranging from 0 to 10
Time Frame
10 minutes
Secondary Outcome Measure Information:
Title
Operative time
Description
From the introduction of hysteroscope into the vagina till compilation of hysteroscopic examination
Time Frame
15 minutes
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
patients with an indication for office hysteroscopy
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with an indication for office hysteroscopy
Exclusion Criteria:
patient refuse to participant
contraindication for lidocaine patch
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
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Transdermal Lidocaine for Pain Control During Diagnostic Office Hysteroscopy
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