NulliparityNCT03298646
Lidocaine Infusion On Hysteroscopic Media Versus Oral Diclofinac For Pain Relief During Outpatient Hysteroscopy
A study testing Lidocaine Hydrochloride and Diclofenac in people with Nulliparity, run by Ain Shams University at 1 site in Egypt.
Trial summary
Lidocaine Infusion On Hysteroscopic Media Versus Oral Diclofinac For Pain Relief During Outpatient Hysteroscopy. A Randomized Controlled Trial. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Nulliparity
- What is being tested?
- Lidocaine Hydrochloride and Diclofenac
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2017to Jan 2018
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 18-35 years.
- BMI 18.5-30 Kg.
- Nulliparous women assigned for diagnostic hysteroscopy.
- Informed written consent.
Who cannot join
- Previous cervical surgery.
- Cervical stenosis.
- Known gastritis.
- Recent or active PID.
- Cardiac patients.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams maternity hospital
Cairo
ain shams university, 01005646995, elbohoty79@yahoo.com
ahmed elbohoty, 01005646995
About this study
Official title: Lidocaine Infusion On Hysteroscopic Media Versus Oral Diclofinac For Pain Relief During Outpatient Hysteroscopy: A Randomized Controlled Trial
Lidocaine Infusion On Hysteroscopic Media Versus Oral Diclofinac For Pain Relief During Outpatient Hysteroscopy. A Randomized Controlled Trial.
Read the detailed description
10 ml of 2% lidocaine hydrochloride added on saline infusion media versus 100 mg diclofenac tablet 1 hour before office hysteroscopy , to test their efficacy in reducing pain .
- Conditions
- Nulliparity
- Being tested
- Lidocaine Hydrochloride, Diclofenac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine HydrochlorideDrug
10 ml of 2% lidocaine on hysteroscopic infusion media during office hysteroscopy.
DiclofenacDrug
100 mg Diclofenac oral tablet one hour before the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Lidacaine hydrochloride | Experimental | Adding 10 ml of 2% Lidocaine hydrochloride on hysteroscopic saline media during office hysteroscopy to test its efficacy in reducing pain.
22 women. Receives: Drug: Lidocaine Hydrochloride |
| Diclofenac | Active comparator | 100 mg Diclofenac oral tablet is administered 1 hour before the procedure to test its efficacy in reducing pain.
22 women. Receives: Drug: Diclofenac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain reduction using Visual Analogue Scale
Efficacy of lidocaine on saline media and oral diclofenac in reducing pain during office hysteroscopy from start of the procedure till 30 minutes after, using visual analogue scale to assess the severity of pain
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2017
- Study startOct 2017 (estimated)
- Primary completionDec 2017 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NulliparityStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Elsayed Hassan Elbohoty, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03298646
- Sponsor's protocol ID
- Hysteroscopy
- Status last verified
- Sep 2017
- First submitted
- 30 Aug 2017
- Last updated
- 2 Oct 2017
- 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 2 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lidocaine Infusion On Hysteroscopic Media Versus Oral Diclofinac For Pain Relief During Outpatient Hysteroscopy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03298646
- Acronym / sponsor ID
- Hysteroscopy
- Conditions
- Nulliparity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Oct 2017 (estimated)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 2 Oct 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 Infusion On Hysteroscopic Media Versus Oral Diclofinac For Pain Relief During Outpatient Hysteroscopy. A Randomized Controlled Trial.
Detailed description
10 ml of 2% lidocaine hydrochloride added on saline infusion media versus 100 mg diclofenac tablet 1 hour before office hysteroscopy , to test their efficacy in reducing pain .
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidacaine hydrochloride | Experimental | Drug: Lidocaine HydrochlorideAdding 10 ml of 2% Lidocaine hydrochloride on hysteroscopic saline media during office hysteroscopy to test its efficacy in reducing pain. 22 women. |
| Diclofenac | Active comparator | Drug: Diclofenac100 mg Diclofenac oral tablet is administered 1 hour before the procedure to test its efficacy in reducing pain. 22 women. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age: 18-35 years.
- BMI 18.5-30 Kg.
- Nulliparous women assigned for diagnostic hysteroscopy.
- Informed written consent.
Key exclusion criteria (5 listed)
- Previous cervical surgery.
- Cervical stenosis.
- Known gastritis.
- Recent or active PID.
- Cardiac patients.
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 Hydrochloride10 ml of 2% lidocaine on hysteroscopic infusion media during office hysteroscopy. | Drug | Lidacaine hydrochloride |
| Diclofenac100 mg Diclofenac oral tablet one hour before the procedure. | Drug | Diclofenac |
Primary outcome
Pain reduction using Visual Analogue Scale
Time frame: 30 minutes
Efficacy of lidocaine on saline media and oral diclofenac in reducing pain during office hysteroscopy from start of the procedure till 30 minutes after, using visual analogue scale to assess the severity of pain
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2017.
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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.
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 Hydrochloride and Diclofenac in people with Nulliparity, run by Ain Shams University 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 4 inclusion and 5 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 2 Oct 2017. 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. 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?
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 reduction using Visual Analogue Scale (time frame: 30 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 2 Oct 2017.