PainNCT02039661
Effect of Lidocaine Spray for Pain Relief During Endometrial Biopsy: a Randomized, Double-blind, Placebo-controlled Clinical Trial
A study testing Lidocaine Spray in people with Pain, run by Kayseri Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The effect of lidocaine spray on pain relief during endometrial sampling. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Pain
- What is being tested?
- Lidocaine Spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Nov 2013to Jan 2014
- 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 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age>18 years no allergy Patients with abnormal uterine bleeding
Who cannot join
- cervical stenosis myoma uteri pregnancy miscarriage chronic pelvic pain dysmenorrhea
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kayseri Education and Research Hospital of Medicine
Kayseri, 38210
About this study
The effect of lidocaine spray on pain relief during endometrial sampling.
Read the detailed description
The study population will comprise women with abnormal uterine bleeding who will be scheduled for endometrial sampling or women who will have control biopsies before surgery due to other pathologies. We have two groups; the first group consisted of patients who receive lidocaine spray. The second group consisted of patients who receive placebo spray. Patients will be asked to rate their pain level on a standard continuous 100-mm VAS to quantify the pain. Pain scoring will be performed at 3 different time points: immediately before to the procedure, during the procedure(immediately following the removal of the speculum from the vagina at the end of the endometrial sampling, the patients will be asked to score their pain level experienced during the procedure), and 15 minutes after the procedure.
We will document the patients' demographics and medical information. All procedures will be performed by a single operator and the same team to avoid possible operator-dependent pain factors (counseling, patient preparation, attitude and operative steps during operation, moral and psychological support).
- Conditions
- Pain
- Being tested
- Lidocaine Spray, Placebo
- Keywords
- Curettage;, Pain Score
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine SprayDrug
These patients received 2 puff lidocaine spray
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine Spray | Active comparator | Not described Receives: Drug: Lidocaine Spray |
| Placebo | Placebo comparator | These patients received placebo spray. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Score
Patients were asked to rate their pain level on a standard continuous 100-mm VAS to quantify the pain. Pain scoring was performed at 3 different time points: immediately before to the procedure, during the procedure (immediately following the removal of the speculum from the vagina at the end of the endometrial sampling, the patients were asked to score their pain level experienced during the procedure), and 15 minutes after the procedure.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2014 (estimated)
- Study startNov 2013
- Primary completionJan 2014
- Study completionJan 2014
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kayseri Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gökhan Açmaz, Kayseri Education and Research Hospital
- Investigators
- Gökhan Açmaz, MD, Principal investigator, Kayseri Education and Research Hospital of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02039661
- Sponsor's protocol ID
- Gookhan
- Status last verified
- Jan 2014
- First submitted
- 16 Jan 2014
- Last updated
- 17 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lidocaine Spray for Pain Relief During Endometrial Biopsy: a Randomized, Double-blind, Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02039661
- Acronym / sponsor ID
- Gookhan
- Conditions
- Pain
- Keywords
- Curettage;, Pain Score
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Kayseri Education and Research HospitalOther government
- Study start
- Nov 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 17 Jan 2014 (estimated)
- 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.
The effect of lidocaine spray on pain relief during endometrial sampling.
Detailed description
The study population will comprise women with abnormal uterine bleeding who will be scheduled for endometrial sampling or women who will have control biopsies before surgery due to other pathologies. We have two groups; the first group consisted of patients who receive lidocaine spray. The second group consisted of patients who receive placebo spray. Patients will be asked to rate their pain level on a standard continuous 100-mm VAS to quantify the pain. Pain scoring will be performed at 3 different time points: immediately before to the procedure, during the procedure(immediately following the removal of the speculum from the vagina at the end of the endometrial sampling, the patients will be asked to score their pain level experienced during the procedure), and 15 minutes after the procedure.
We will document the patients' demographics and medical information. All procedures will be performed by a single operator and the same team to avoid possible operator-dependent pain factors (counseling, patient preparation, attitude and operative steps during operation, moral and psychological support).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine Spray | Active comparator | Drug: Lidocaine Spray |
| Placebo | Placebo comparator | Drug: PlaceboThese patients received placebo spray. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Age>18 years no allergy Patients with abnormal uterine bleeding
Key exclusion criteria (1 listed)
- cervical stenosis myoma uteri pregnancy miscarriage chronic pelvic pain dysmenorrhea
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 SprayThese patients received 2 puff lidocaine spray | Drug | Lidocaine Spray |
| Placebo | Drug | Placebo |
Primary outcome
Pain Score
Time frame: 3 months
Patients were asked to rate their pain level on a standard continuous 100-mm VAS to quantify the pain. Pain scoring was performed at 3 different time points: immediately before to the procedure, during the procedure (immediately following the removal of the speculum from the vagina at the end of the endometrial sampling, the patients were asked to score their pain level experienced during the procedure), and 15 minutes 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 17 Jan 2014.
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
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.
Gökhan Açmaz, MD principal investigator
Kayseri Education and Research Hospital of Medicine
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 Spray in people with Pain, run by Kayseri Education and Research 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 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: finished, as of the sponsor's last update on 17 Jan 2014. 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. 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.
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?
Pain Score (time frame: 3 months). 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 17 Jan 2014.