Infertility, FemaleNCT04518202
Transdermal Lidocaine for Pain Control During Diagnostic Office Hysteroscopy
A study testing lidocaine patch in people with Infertility, Female, run by Aswan University Hospital at 1 site in Egypt.
Trial summary
To compare the effectiveness of Transdermal Lidocaine for Pain Control During Diagnostic Office Hysteroscopy Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Infertility, Female
- What is being tested?
- lidocaine patch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2020to 30 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- patients with an indication for office hysteroscopy
Who cannot join
- patient refuse to participant
- contraindication for lidocaine patch
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transdermal Lidocaine for Pain Control During Diagnostic Office Hysteroscopy: a Randomized Controlled Trial
To compare the effectiveness of Transdermal Lidocaine for Pain Control During Diagnostic Office Hysteroscopy
Read the 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.
- Conditions
- Infertility, Female
- Being tested
- lidocaine patch, Sham patch
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lidocaine patchDrug
Also called Experimental
5% lidocaine patch applied at 6 hours before the scheduled office hysteroscopy.
Sham patchDrug
Also called Placebo Comparator
Sham patch containing no study medication applied at 6 hours before the scheduled office hysteroscopy.
| Study group | Role | What they receive |
|---|---|---|
| lidocaine patch | Experimental | 5% lidocaine patch applied at 6 hours before the scheduled office hysteroscopy. Receives: Drug: lidocaine patch |
| Sham patch | Placebo comparator | Sham patch applied at 6 hours before the scheduled office hysteroscopy. Receives: Drug: Sham patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10 minutes
Secondary outcomes (1)
Operative time
From the introduction of hysteroscope into the vagina till compilation of hysteroscopic examination
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2020
- Study start1 Sep 2020 (estimated)
- Primary completion31 Aug 2021 (estimated)
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- double blinded randomized controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aswan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hany farouk, Aswan University Hospital
- Investigators
- nahla w Shady, md, Study chair, Aswan universirty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04518202
- Sponsor's protocol ID
- aswu/296/3/19
- Status last verified
- Aug 2020
- First submitted
- 15 Aug 2020
- Last updated
- 19 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transdermal Lidocaine for Pain Control During Diagnostic Office Hysteroscopy: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04518202
- Acronym / sponsor ID
- aswu/296/3/19
- Conditions
- Infertility, Female
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Aswan University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 31 Aug 2021 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 19 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- double blinded randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| lidocaine patch | Experimental | Drug: lidocaine patch5% lidocaine patch applied at 6 hours before the scheduled office hysteroscopy. |
| Sham patch | Placebo comparator | Drug: Sham patchSham patch applied at 6 hours before the scheduled office hysteroscopy. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients with an indication for office hysteroscopy
Key exclusion criteria (2 listed)
- patient refuse to participant
- contraindication for lidocaine patch
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lidocaine patchAlso: Experimental5% lidocaine patch applied at 6 hours before the scheduled office hysteroscopy. | Drug | lidocaine patch |
| Sham patchAlso: Placebo ComparatorSham patch containing no study medication applied at 6 hours before the scheduled office hysteroscopy. | Drug | Sham patch |
Primary outcome
Pain intensity will be assessed by visual analogue scale
Time frame: 10 minutes
Pain intensity will be assessed by visual analogue scale 30 minutes after the procedure. Visual analogue scale ranging from 0 to 10
1 secondary outcome
Operative time
Time frame: 15 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2020.
- Individual participant dataSharing planned: No
Related trials for Infertility, Female
Recruiting
Endometriosis Transcriptomic Cell Atlas
Endometriosis, Infertility
RecruitingPhase 1
Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
Anovulatory Infertility
RecruitingPhase 2
A Study to Investigate Mibavademab in Adult Women With Functional Hypothalamic Amenorrhea
Functional Hypothalamic Amenorrhea, FHA
Not yet recruitingPhase 2
PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
Endometriosis Pelvic, Endometriosis Ovaries
Recruiting
Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
Isthmocele, Cesarean Scar Defect
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
nahla w Shady, md study chair
Aswan universirty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lidocaine patch in people with Infertility, Female, run by Aswan University Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact hany f Sallam, md (+20102435461 ext. 002, hany.farouk@aswu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity will be assessed by visual analogue scale (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2020.