PainPhase 2NCT03825016
Lidocaine Infusion in Hystroscopy
A Phase 2 study testing Lidocaine Hydrochloride and Diclofenac Sodium in people with Pain, run by Ain Shams University at 1 site in Egypt.
Trial summary
Lidocaine infusion in hystroscopic media versus oral diclofenac 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
- Pain
- What is being tested?
- Lidocaine Hydrochloride and Diclofenac Sodium
- 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
- 1 Aug 2017to 10 Jan 2020
- Phase
- Phase 2
- 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/m2
- Diagnostic hystroscope
Who cannot join
- Previous cervical surgery
- Cervical stenosis
- PID
- allergy to NSAID
- Gastritis or peptic ulcer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lidocaine Infusion Versus Oral Diclofenac During Outpatient Hystroscopy: A Randomized Clinical Trial
Lidocaine infusion in hystroscopic media versus oral diclofenac
- Conditions
- Pain
- Being tested
- Lidocaine Hydrochloride, Diclofenac Sodium
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine HydrochlorideDrug
Lidocaine infusion on hystroscopic media during office hystroscopy
Diclofenac SodiumDrug
Oral Diclofenac Sodium
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine | Experimental | Lidocaine Hydrochloride Receives: Drug: Lidocaine Hydrochloride |
| Diclofenac | Experimental | Oral Diclofenac Receives: Drug: Diclofenac Sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of pain "measured by visual analogue scale"
measured by visual analogue scale
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2019
- Study start1 Aug 2017
- Primary completion10 Jan 2020
- Study completion10 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed S Sweed, MD, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03825016
- Sponsor's protocol ID
- AS1855
- Status last verified
- Jan 2020
- First submitted
- 30 Jan 2019
- Last updated
- 28 Jan 2020
- 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 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lidocaine Infusion Versus Oral Diclofenac During Outpatient Hystroscopy: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03825016
- Acronym / sponsor ID
- AS1855
- Conditions
- Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 10 Jan 2020 (actual)
- Study completion
- 10 Jan 2020 (actual)
- First posted
- 31 Jan 2019 (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 in hystroscopic media versus oral diclofenac
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine | Experimental | Drug: Lidocaine HydrochlorideLidocaine Hydrochloride |
| Diclofenac | Experimental | Drug: Diclofenac SodiumOral Diclofenac |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 18-35 years
- BMI 18.5-30 kg/m2
- Diagnostic hystroscope
Key exclusion criteria (5 listed)
- Previous cervical surgery
- Cervical stenosis
- PID
- allergy to NSAID
- Gastritis or peptic ulcer
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 HydrochlorideLidocaine infusion on hystroscopic media during office hystroscopy | Drug | Lidocaine |
| Diclofenac SodiumOral Diclofenac Sodium | Drug | Diclofenac |
Primary outcome
Degree of pain "measured by visual analogue scale"
Time frame: 1 hour
measured by visual analogue scale
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lidocaine Hydrochloride and Diclofenac Sodium in people with Pain, 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 3 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: finished, as of the sponsor's last update on 28 Jan 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of pain "measured by visual analogue scale" (time frame: 1 hour). 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 28 Jan 2020.