Pain During HysteroscopyNCT01718314
Comparison of Sublingual Misoprostol Versus Lidocaine Spray for Hysteroscopy
A study testing Sublingual Misoprostol and Lidocaine pump spray in people with Pain During Hysteroscopy, run by Dr. Sami Ulus Children's Hospital at 1 site in Turkey (Türkiye).
Trial summary
Hysteroscopy is an instrument to visualize the interior walls of uterus (womb) and it enables the doctor to do minor operative procedures. Although it causes little discomfort, sometimes it may be disturbing for the patient. Read more about this study
- Who is it for?
- Ages 18 to 51 years, women only
- Conditions the study is for
- Pain During Hysteroscopy
- What is being tested?
- Sublingual Misoprostol and Lidocaine pump spray
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 138 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Mar 2008to Mar 2010
- 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 51 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Premenopausal women in the proliferative phase of the menstrual cycle with no contraindication for hysteroscopy
Who cannot join
- vaginal bleeding at the time of the procedure
- known sensitivity to lidocaine (amide group local anesthetics) or prostaglandins
- epilepsy
- significantly impaired respiratory or cardiac conduction functions
- hypertension
- glaucoma
Show all 13Show fewer
- renal failure
- acute liver disease
- uncontrolled diabetes mellitus
- pregnancy or suspicion of pregnancy
- pelvic inflammatory disease
- cervical operation history
- vaginismus.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dr Sami Ulus Maternity and Children Training and Research Hospital
Ankara, 06090
About this study
Official title: Comparison of Sublingual Misoprostol Versus Lidocaine Spray for Pain Relief in Office Hysteroscopy: A Randomized, Double Blind, Placebo-Controlled Trial
Hysteroscopy is an instrument to visualize the interior walls of uterus (womb) and it enables the doctor to do minor operative procedures. Although it causes little discomfort, sometimes it may be disturbing for the patient. This pain is usually perceived during the passage of the instrument through the cervix (neck of the womb). The investigators would like to minimize this pain by two drugs: Misoprotol and lidocaine
Read the detailed description
Outpatient or office hysteroscopy has become the 'gold standard' for the investigation of the intrauterine abnormalities. This minimal invasive modality provides brilliant and clear visualization of the entire uterine cavity and besides this, by the operative channel, minor procedures may easily be performed in the office setting which is priceless for the gynecologist. However, pain related to the procedure may make the procedure uncomfortable for the patient and the physician. Together with the operative time, hysteroscope diameter is considered as the main factor influencing pain. The pain perceived during hysteroscopy may be reduced by using a smaller diameter hysteroscope or by using anesthesia, which decreases pain perception.
In this prospective, randomized, double blind, placebo controlled study, we aim to compare the effectiveness of sublingual misoprostol versus lidocaine pump spray for pain relief during office hysteroscopy.
- Conditions
- Pain During Hysteroscopy
- Being tested
- Sublingual Misoprostol, Lidocaine pump spray, Placebo (for Misoprostol), Placebo (for Lidocaine)
- Keywords
- Hysteroscopy, Misoprostol, Lidocaine, Visual analogue score
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sublingual MisoprostolDrug
Also called Cytotec
Lidocaine pump sprayDrug
Also called Xylocaine %10 pump spray
Placebo (for Misoprostol)Drug
Lactose filler, the pharmacy-produced pills identical to original misoprostol pill
Placebo (for Lidocaine)Drug
The pharmacy-produced sterile saline containing pump spray external characteristics identical to lidocaine pump spray
| Study group | Role | What they receive |
|---|---|---|
| Sublingual Misoprostol & Lidocaine placebo | Experimental | Misoprostol 200 µg sublingually single dose and Lidocaine spray placebo Receives: Drug: Sublingual Misoprostol; Drug: Placebo (for Lidocaine) |
| Lidocaine Pump Spray & Misoprostol placebo | Experimental | Lidocaine Pump spray, 6 sprays to cervix (60 mg totally) and sublingual misoprotol placebo Receives: Drug: Lidocaine pump spray; Drug: Placebo (for Misoprostol) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient VAS score immediately after the procedure
Measured: Immediately after the procedure
Secondary outcomes (1)
Patient VAS score 10 minutes after the procedure
Measured: 10 minutes after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2012 (estimated)
- Study startMar 2008
- Primary completionDec 2009
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pain During HysteroscopyStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Sami Ulus Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sertac ESIN, Dr. Sami Ulus Children's Hospital
- Investigators
- Tuncay Kucukozkan, Professor, Study chair, Sami Ulus Maternity and Childrens Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01718314
- Sponsor's protocol ID
- HEK 11/33-21
- Status last verified
- Oct 2012
- First submitted
- 29 Oct 2012
- Last updated
- 31 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
van Dongen H, de Kroon CD, Jacobi CE, Trimbos JB, Jansen FW. Diagnostic hysteroscopy in abnormal uterine bleeding: a systematic review and meta-analysis. BJOG. 2007 Jun;114(6):664-75. doi: 10.1111/j.1471-0528.2007.01326.x.
PubMed 17516956De Iaco P, Marabini A, Stefanetti M, Del Vecchio C, Bovicelli L. Acceptability and pain of outpatient hysteroscopy. J Am Assoc Gynecol Laparosc. 2000 Feb;7(1):71-5. doi: 10.1016/s1074-3804(00)80012-2.
PubMed 10648742Mulayim B, Celik NY, Onalan G, Bagis T, Zeyneloglu HB. Sublingual misoprostol for cervical ripening before diagnostic hysteroscopy in premenopausal women: a randomized, double blind, placebo-controlled trial. Fertil Steril. 2010 May 1;93(7):2400-4. doi: 10.1016/j.fertnstert.2009.01.073. Epub 2009 Feb 24.
PubMed 19243750
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Sublingual Misoprostol Versus Lidocaine Spray for Pain Relief in Office Hysteroscopy: A Randomized, Double Blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT01718314
- Acronym / sponsor ID
- HEK 11/33-21
- Conditions
- Pain During Hysteroscopy
- Keywords
- Hysteroscopy, Misoprostol, Lidocaine, Visual analogue score
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Dr. Sami Ulus Children's HospitalUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 31 Oct 2012 (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.
Hysteroscopy is an instrument to visualize the interior walls of uterus (womb) and it enables the doctor to do minor operative procedures. Although it causes little discomfort, sometimes it may be disturbing for the patient. This pain is usually perceived during the passage of the instrument through the cervix (neck of the womb). The investigators would like to minimize this pain by two drugs: Misoprotol and lidocaine
Detailed description
Outpatient or office hysteroscopy has become the 'gold standard' for the investigation of the intrauterine abnormalities. This minimal invasive modality provides brilliant and clear visualization of the entire uterine cavity and besides this, by the operative channel, minor procedures may easily be performed in the office setting which is priceless for the gynecologist. However, pain related to the procedure may make the procedure uncomfortable for the patient and the physician. Together with the operative time, hysteroscope diameter is considered as the main factor influencing pain. The pain perceived during hysteroscopy may be reduced by using a smaller diameter hysteroscope or by using anesthesia, which decreases pain perception.
In this prospective, randomized, double blind, placebo controlled study, we aim to compare the effectiveness of sublingual misoprostol versus lidocaine pump spray for pain relief during office hysteroscopy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sublingual Misoprostol & Lidocaine placebo | Experimental | Drug: Sublingual Misoprostol, Drug: Placebo (for Lidocaine)Misoprostol 200 µg sublingually single dose and Lidocaine spray placebo |
| Lidocaine Pump Spray & Misoprostol placebo | Experimental | Drug: Lidocaine pump spray, Drug: Placebo (for Misoprostol)Lidocaine Pump spray, 6 sprays to cervix (60 mg totally) and sublingual misoprotol placebo |
Who may qualify
- Ages
- 18 to 51 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Premenopausal women in the proliferative phase of the menstrual cycle with no contraindication for hysteroscopy
Key exclusion criteria (13 listed)
- vaginal bleeding at the time of the procedure
- known sensitivity to lidocaine (amide group local anesthetics) or prostaglandins
- epilepsy
- significantly impaired respiratory or cardiac conduction functions
- hypertension
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 |
|---|---|---|
| Sublingual MisoprostolAlso: Cytotec | Drug | Sublingual Misoprostol & Lidocaine placebo |
| Lidocaine pump sprayAlso: Xylocaine %10 pump spray | Drug | Lidocaine Pump Spray & Misoprostol placebo |
| Placebo (for Misoprostol)Lactose filler, the pharmacy-produced pills identical to original misoprostol pill | Drug | Lidocaine Pump Spray & Misoprostol placebo |
| Placebo (for Lidocaine)The pharmacy-produced sterile saline containing pump spray external characteristics identical to lidocaine pump spray | Drug | Sublingual Misoprostol & Lidocaine placebo |
Primary outcome
Patient VAS score immediately after the procedure
Time frame: Immediately after the procedure
1 secondary outcome
Patient VAS score 10 minutes after the procedure
Time frame: 10 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 31 Oct 2012.
- Results publication: PubMed 17516956van Dongen H, de Kroon CD, Jacobi CE, Trimbos JB, Jansen FW. Diagnostic hysteroscopy in abnormal uterine bleeding: a systematic review and meta-analysis. BJOG. 2007 Jun;114(6):664-75. doi: 10.1111/j.1471-0528.2007.01326.x.
- Results publication: PubMed 10648742De Iaco P, Marabini A, Stefanetti M, Del Vecchio C, Bovicelli L. Acceptability and pain of outpatient hysteroscopy. J Am Assoc Gynecol Laparosc. 2000 Feb;7(1):71-5. doi: 10.1016/s1074-3804(00)80012-2.
- Results publication: PubMed 19243750Mulayim B, Celik NY, Onalan G, Bagis T, Zeyneloglu HB. Sublingual misoprostol for cervical ripening before diagnostic hysteroscopy in premenopausal women: a randomized, double blind, placebo-controlled trial. Fertil Steril. 2010 May 1;93(7):2400-4. doi: 10.1016/j.fertnstert.2009.01.073. Epub 2009 Feb 24.
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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.
Tuncay Kucukozkan, Professor study chair
Sami Ulus Maternity and Childrens Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sublingual Misoprostol and Lidocaine pump spray in people with Pain During Hysteroscopy, run by Dr. Sami Ulus Children's 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 13 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 31 Oct 2012. 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.
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?
Patient VAS score immediately after the procedure (time frame: Immediately after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01718314, which also lists 3 linked publications.
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 31 Oct 2012.