Uterine BleedingPhase 3NCT03075358
Effects of Lidocaine Spray for Reducing Pain During Endometrial Aspiration Biopsy : a Randomized Controlled Trial
A Phase 3 study testing Lidocaine spray and Normal saline spray in people with Uterine Bleeding, run by Chiang Mai University at 1 site in Thailand.
Trial summary
Endometrial aspiration biopsy has been accepted as a diagnostic procedure of choice for women with abnormal uterine bleeding to examine endometrial pathology. The procedure has high accuracy comparing to conventional fractional curettage. However, it is associated with significant pain during the procedure. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Uterine Bleeding
- What is being tested?
- Lidocaine spray and Normal saline spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteThailand
- Study dates
- 6 Mar 2017to 15 Jan 2018
- Phase
- Phase 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women undergoing endometrial aspiration biopsy at Maharaj Nakorn Chiang Mai hospital
Who cannot join
- Lidocaine allergy
- Pregnancy
- Previous uterine or cervical surgical procedures
- Neurological abnormalities
- Coagulopathy
- Infection of cervix, vagina, or pelvic cavity
- Taking any analgesic drugs within 4 hours before the procedure
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Department of OB-GYN, Faculty of Medicine, Chiang Mai University
Chiang Mai, 50200
About this study
Endometrial aspiration biopsy has been accepted as a diagnostic procedure of choice for women with abnormal uterine bleeding to examine endometrial pathology. The procedure has high accuracy comparing to conventional fractional curettage. However, it is associated with significant pain during the procedure. In general, there is no specific recommendation regarding the proper anesthesia used during the procedure.
The aim of this study is to examine the effect of lidocaine spray for reducing pain during the endometrial aspiration procedure by comparing it with placebo and no intervention.
- Conditions
- Uterine Bleeding
- Being tested
- Lidocaine spray, Normal saline spray
- Medical subject headings
- Uterine Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine sprayDrug
Patients are locally anesthetized with 8 puffs (80 mg, 10mg/puff, 0.8 ml) of 10% lidocaine spray applied thoroughly to the cervix, 3 minutes before starting the procedure.
Normal saline sprayOther
0.8 ml of normal saline spray is applied to the cervix, 3 minutes before starting the procedure
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine spray | Experimental | Not described Receives: Drug: Lidocaine spray |
| Normal saline spray | Sham comparator | Not described Receives: Other: Normal saline spray |
| No spray | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aspiration pain
A visual analog scale pain score associated with endometrial aspiration biopsy
Measured: Immediately following endometrial aspiration biopsy
Postprocedure pain
A visual analog scale pain score after the procedure
Measured: 10 minute after procedure completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2017
- Study start6 Mar 2017
- Primary completion15 Jan 2018
- Study completion15 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine BleedingStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiang Mai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kittipat Charoenkwan, MD, Chiang Mai University
- Investigators
- Kittipat Charoenkwan, MD, MSc, Study chair, Faculty of Medicine, Chiang Mai UniversityRatpaporn Piyawetchakarn, MD, Principal investigator, Faculty of Medicine, Chiang Mai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03075358
- Sponsor's protocol ID
- OBG-2559-04137
- Status last verified
- Mar 2018
- First submitted
- 6 Mar 2017
- Last updated
- 27 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Lidocaine Spray for Reducing Pain During Endometrial Aspiration Biopsy : a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03075358
- Acronym / sponsor ID
- OBG-2559-04137
- Conditions
- Uterine Bleeding
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Chiang Mai UniversityUniversity, hospital or other
- Study start
- 6 Mar 2017 (actual)
- Primary completion
- 15 Jan 2018 (actual)
- Study completion
- 15 Jan 2018 (actual)
- First posted
- 9 Mar 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.
Endometrial aspiration biopsy has been accepted as a diagnostic procedure of choice for women with abnormal uterine bleeding to examine endometrial pathology. The procedure has high accuracy comparing to conventional fractional curettage. However, it is associated with significant pain during the procedure. In general, there is no specific recommendation regarding the proper anesthesia used during the procedure.
The aim of this study is to examine the effect of lidocaine spray for reducing pain during the endometrial aspiration procedure by comparing it with placebo and no intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lidocaine spray | Experimental | Drug: Lidocaine spray |
| Normal saline spray | Sham comparator | Other: Normal saline spray |
| No spray | No intervention | – |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women undergoing endometrial aspiration biopsy at Maharaj Nakorn Chiang Mai hospital
Key exclusion criteria (7 listed)
- Lidocaine allergy
- Pregnancy
- Previous uterine or cervical surgical procedures
- Neurological abnormalities
- Coagulopathy
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 sprayPatients are locally anesthetized with 8 puffs (80 mg, 10mg/puff, 0.8 ml) of 10% lidocaine spray applied thoroughly to the cervix, 3 minutes before starting the procedure. | Drug | Lidocaine spray |
| Normal saline spray0.8 ml of normal saline spray is applied to the cervix, 3 minutes before starting the procedure | Other | Normal saline spray |
Primary outcome
Aspiration pain
Time frame: Immediately following endometrial aspiration biopsy
A visual analog scale pain score associated with endometrial aspiration biopsy
Postprocedure pain
Time frame: 10 minute after procedure completion
A visual analog scale pain score after the procedure
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 27 Mar 2018.
- Individual participant dataSharing planned: Undecided
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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.
Kittipat Charoenkwan, MD, MSc study chair
Faculty of Medicine, Chiang Mai University
Ratpaporn Piyawetchakarn, MD principal investigator
Faculty of Medicine, Chiang Mai University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lidocaine spray and Normal saline spray in people with Uterine Bleeding, run by Chiang Mai University at 1 site in Thailand.
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 7 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 27 Mar 2018. 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 Thailand. 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.
What does this phase mean?
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?
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?
Aspiration pain (time frame: Immediately following endometrial aspiration biopsy). 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 27 Mar 2018.