AnalgesiaPhase 4NCT06540599
Optimizing Analgesia for Endometrial Biopsy
A Phase 4 study testing Analgesic in people with Analgesia, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
Comparison of the effectiveness of intrauterine lidocaine-paracervical block-dexketoprofen tromematol- lidocaine spray in endometrial biopsy analgesia Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Analgesia
- What is being tested?
- Analgesic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 197 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2022to 1 Nov 2022
- Phase
- Phase 4
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- women aged 18-75 needs endometrial biopsy
Who cannot join
- women with allergies to prilocaine, lidocaine or dexketoprofen trometamol
- women with a history of severe uncontrolled cardiovascular disease, diabetes mellitus, pregnancy, vaginal, cervical, or pelvic infection, cervical cancer, or severe cervical stenosis
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziosmanpaşa Training and Research Hospital
Istanbul
About this study
Official title: Optimizing Analgesia for Endometrial Biopsy: A Prospective, Randomized Comparative Study
Comparison of the effectiveness of intrauterine lidocaine-paracervical block-dexketoprofen tromematol- lidocaine spray in endometrial biopsy analgesia
- Conditions
- Analgesia
- Being tested
- Analgesic
- Keywords
- endometrial biopsy, intrauterine lidocaine, pain management
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnalgesicDrug
comparing the effectiveness of analgesics in endometrial biopsy
| Study group | Role | What they receive |
|---|---|---|
| Patients using intrauterine lidocaine for analgesia | Active comparator | Not described Receives: Drug: Analgesic |
| Patients using oral dexketoprofen for analgesia | Active comparator | Not described Receives: Drug: Analgesic |
| Patients using cervical lidocaine spray for analgesia | Active comparator | Not described Receives: Drug: Analgesic |
| Patients using paracervical block with prilocaine for analgesia | Active comparator | Not described Receives: Drug: Analgesic |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparing analgesics in endometrial biopsy using The Visual Analogue Scale (VAS).
post operative VAS scores will be compared for each drug.The VAS measures pain intensity. The VAS consists of a 10 cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). In this context, higher scores represent worse results.
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 posted6 Aug 2024
- Study start1 Sep 2022
- Primary completion1 Oct 2022
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06540599
- Sponsor's protocol ID
- GaziosmanpasaTREHes
- Status last verified
- Mar 2022
- First submitted
- 2 Aug 2024
- Last updated
- 9 Aug 2024
- 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 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Analgesia for Endometrial Biopsy: A Prospective, Randomized Comparative Study
- ClinicalTrials.gov ID
- NCT06540599
- Acronym / sponsor ID
- GaziosmanpasaTREHes
- Conditions
- Analgesia
- Keywords
- endometrial biopsy, intrauterine lidocaine, pain management
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 6 Aug 2024 (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.
Comparison of the effectiveness of intrauterine lidocaine-paracervical block-dexketoprofen tromematol- lidocaine spray in endometrial biopsy analgesia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patients using intrauterine lidocaine for analgesia | Active comparator | Drug: Analgesic |
| Patients using oral dexketoprofen for analgesia | Active comparator | Drug: Analgesic |
| Patients using cervical lidocaine spray for analgesia | Active comparator | Drug: Analgesic |
| Patients using paracervical block with prilocaine for analgesia | Active comparator | Drug: Analgesic |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- women aged 18-75 needs endometrial biopsy
Key exclusion criteria (2 listed)
- women with allergies to prilocaine, lidocaine or dexketoprofen trometamol
- women with a history of severe uncontrolled cardiovascular disease, diabetes mellitus, pregnancy, vaginal, cervical, or pelvic infection, cervical cancer, or severe cervical stenosis
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 |
|---|---|---|
| Analgesiccomparing the effectiveness of analgesics in endometrial biopsy | Drug | Patients using cervical lidocaine spray for analgesia, Patients using intrauterine lidocaine for analgesia, Patients using oral dexketoprofen for analgesia, Patients using paracervical block with prilocaine for analgesia |
Primary outcome
comparing analgesics in endometrial biopsy using The Visual Analogue Scale (VAS).
Time frame: 1 hour
post operative VAS scores will be compared for each drug.The VAS measures pain intensity. The VAS consists of a 10 cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). In this context, higher scores represent worse results.
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 9 Aug 2024.
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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 4 study testing Analgesic in people with Analgesia, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
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: finished, as of the sponsor's last update on 9 Aug 2024. 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 Turkey (Türkiye). 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
comparing analgesics in endometrial biopsy using The Visual Analogue Scale (VAS). (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 9 Aug 2024.