Pain UterusPhase 2/3NCT03382743
Endocervical Lidocaine Spray for Pain Control During Office Hysteroscopy
A Phase 2/3 study testing Endocervical Lidocaine spray in people with Pain Uterus, run by Kasr El Aini Hospital at 2 sites in Egypt.
Trial summary
lidocaine spray is used endocervical before office hysteroscopy to reduce the pain Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Pain Uterus
- What is being tested?
- Endocervical Lidocaine spray
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesEgypt
- Study dates
- 20 Dec 2017to Mar 2018
- Phase
- Phase 2/3
- 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 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients indicated for diagnostic hysteroscopy for infertility or AUB. Postmenstrual between days 7 and 11 of the cycle ( except in irregular bleeding)
Who cannot join
- Contraindication to office hysteroscopy Neurological disorders affecting the evaluation of pain. Previous cervical surgery.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
Kasr El Ainiy Hospital
Cairo, 11562
sarah M Hassan, Lecturer, 01003733671, saramohamed7880@yahoo.com
- Recruiting
Kasr Alaini hospital
Cairo
Sarah M hassan, lecturer, 01003733671, saramohamed7880@yahoo.com
Wafaa R Desouky, MD
About this study
Official title: Endocervical Lidocaine Spray for Pain Control During Office Hysteroscopy - a Randomized Control Trial.
lidocaine spray is used endocervical before office hysteroscopy to reduce the pain
Read the detailed description
5 sprays of Lidocaine is applied 3 minutes before office hysteroscopy
- Conditions
- Pain Uterus
- Being tested
- Endocervical Lidocaine spray
- Keywords
- office hysteroscopy, Lidocaine spray
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endocervical Lidocaine sprayDrug
5 sprays of endocervical Lidocaine spray (10%) is used 3 minutes before office hysteroscopy
| Study group | Role | What they receive |
|---|---|---|
| Group A (Lidocaine group) | Active comparator | 5 sprays of endocervical Lidocaine 10% spray ( AstraZeneca, bedforshire) are used 3 minutes before office hysteroscopy Receives: Drug: Endocervical Lidocaine spray |
| Group B (control group) | No intervention | office hysteroscopy is done without analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain sensation
The level of pelvic pain will be rated according to a 10-point visual analogue scale (VAS)
Measured: The VAS will be applied immediately after the procedure ended
Procedure time
from introduction of the office hysteroscopy through the external cervical os and the visualization of the uterine cavity
Measured: immediately after the process
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2017
- Study start20 Dec 2017
- Primary completionMar 2018 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain UterusStudies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, sarah mohamed hassan, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03382743
- Sponsor's protocol ID
- 171217
- Status last verified
- Jan 2018
- First submitted
- 19 Dec 2017
- Last updated
- 24 Jan 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endocervical Lidocaine Spray for Pain Control During Office Hysteroscopy - a Randomized Control Trial.
- ClinicalTrials.gov ID
- NCT03382743
- Acronym / sponsor ID
- 171217
- Conditions
- Pain Uterus
- Keywords
- office hysteroscopy, Lidocaine spray
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 20 Dec 2017 (actual)
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 26 Dec 2017 (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.
lidocaine spray is used endocervical before office hysteroscopy to reduce the pain
Detailed description
5 sprays of Lidocaine is applied 3 minutes before office hysteroscopy
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Group A (Lidocaine group) | Active comparator | Drug: Endocervical Lidocaine spray5 sprays of endocervical Lidocaine 10% spray ( AstraZeneca, bedforshire) are used 3 minutes before office hysteroscopy |
| Group B (control group) | No intervention | –office hysteroscopy is done without analgesia |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients indicated for diagnostic hysteroscopy for infertility or AUB. Postmenstrual between days 7 and 11 of the cycle ( except in irregular bleeding)
Key exclusion criteria (1 listed)
- Contraindication to office hysteroscopy Neurological disorders affecting the evaluation of pain. Previous cervical surgery.
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 |
|---|---|---|
| Endocervical Lidocaine spray5 sprays of endocervical Lidocaine spray (10%) is used 3 minutes before office hysteroscopy | Drug | Group A (Lidocaine group) |
Primary outcome
Pain sensation
Time frame: The VAS will be applied immediately after the procedure ended
The level of pelvic pain will be rated according to a 10-point visual analogue scale (VAS)
Procedure time
Time frame: immediately after the process
from introduction of the office hysteroscopy through the external cervical os and the visualization of the uterine cavity
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2018.
Related trials for Pain Uterus
Recruiting
Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
Isthmocele, Cesarean Scar Defect
Not yet recruiting
Virtual Reality for Pain and Anxiety During Surgical Uterine Evacuation After Early Pregnancy Loss
Early Pregnancy Loss, Procedural Pain
Not yet recruiting
Ultrasound-Guided Radiofrequency Ablation for Focal Adenomyosis
Adenomyosis, Adenomyoma of Uterus
Recruiting
Ameliorated Pap Tests and Cervical Cancer Screening Participation
Cervical Cancer Screening, Cervical Cancer Screening Methods
RecruitingObservational study
Association of Ultrasound Features of the Myometrium Suggestive of Adenomyosis and Clinical Symptoms
Adenomyosis of Uterus
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Endocervical Lidocaine spray in people with Pain Uterus, run by Kasr El Aini Hospital at 2 sites 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 1 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 24 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain sensation (time frame: The VAS will be applied immediately after the procedure ended). The study lists 2 primary outcomes in all. 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 24 Jan 2018.