Hysteroscopy / MethodsOPTILIDNCT07318285
Targeted Lidocaine Infusion for Pain Reduction in Office Hysteroscopy
A study testing Lidocaine %2 ampoule and Saline (0.9% NaCl) in people with Hysteroscopy / Methods and Lidocaine Infusion, run by YAARA TABIB.
Trial summary
The goal of this study is to find out whether a small amount of lidocaine (a common local anesthetic) can reduce pain during office hysteroscopy - a procedure used to look inside the uterus. The study will compare lidocaine to saline (salt water) to see which one helps more with pain relief. Participants will: 1. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hysteroscopy / Methods, Lidocaine Infusion, Placebo - Control
- What is being tested?
- Lidocaine %2 ampoule and Saline (0.9% NaCl)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 208 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2026to 30 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18
- Referred for outpatient diagnostic or operative (see-and-treat) hysteroscopy
- Able and willing to provide written informed consent
Who cannot join
- Pregnancy
- Active pelvic inflammatory disease or cervicitis
- Inability to consent
- Anti-psychotic drugs usage
- Previews cervical surgery (i.e., conization).
- Any contraindication for office hysteroscopy- cervical malignancy, profuse uterine bleeding, invisible external os, recent uterine perforation.
- Known allergy or hypersensitivity to Lidocaine
About this study
Official title: A Modified Technique of Target Lidocaine Infusion for Pain Control in Office Hysteroscopy: A Double-Blind Randomized Controlled
The goal of this study is to find out whether a small amount of lidocaine (a common local anesthetic) can reduce pain during office hysteroscopy - a procedure used to look inside the uterus. The study will compare lidocaine to saline (salt water) to see which one helps more with pain relief.
Participants will:
- Receive either lidocaine or saline gently applied inside the cervix right before the procedure
- Undergo the hysteroscopy as planned
- Be asked to rate their pain and satisfaction after the procedure
Lidocaine is commonly and safely used in dental and gynecological procedures. Participation is voluntary, and the procedure itself will not change.
- Being tested
- Lidocaine %2 ampoule, Saline (0.9% NaCl)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine %2 ampouleDrug
A 5 mL dose of 2% lidocaine solution will be infused slowly through the internal os using the hysteroscope before the start of uterine cavity distension.
Saline (0.9% NaCl)Other
A 5 mL dose of sterile normal saline will be infused slowly through the internal os using the same technique as in the intervention arm, immediately before cavity distension.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Placebo comparator | Participants in this arm will receive 5 mL of normal saline infused through the internal cervical os immediately before office hysteroscopy. Receives: Other: Saline (0.9% NaCl) |
| Lidocaine Group | Experimental | Participants in this arm will receive 5 mL of 2% lidocaine infused through the internal cervical os immediately before office hysteroscopy. Receives: Drug: Lidocaine %2 ampoule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain During Hysteroscopy Procedure Assessed by Visual Analog Scale (VAS)
Pain experienced during the procedure, evaluated using a Visual Analog Scale (VAS). The VAS score ranging between 0 (no pain) to 10 (worst imaginable pain). Subgroup analyses will be performed by age group, parity, cesarean delivery history, and menopausal status.
Measured: Immediately during the hysteroscopy procedure
Number of Participants with Successful Access to the Uterine Cavity
The number of participants for whom hysteroscopy successfully reached the uterine cavity, without the need to stop or repeat the procedure.
This binary outcome (Yes/No) will be assessed by the performing physician during the procedure. Subgroup analyses will be performed by age group, parity, cesarean delivery history, and menopausal status.
Measured: During the hysteroscopy procedure
Secondary outcomes (5)
Visual Analog Scale (VAS) Pain Score 5 Minutes After the Procedure
Pain intensity assessed using a Visual Analog Scale (VAS) exactly 5 minutes following the end of the hysteroscopy. The VAS score ranging between 0 (no pain) to 10 (worst imaginable pain). Subgroup analyses will be performed by age group, parity, cesarean delivery history, and menopausal status.
Measured: 5 minutes after completion of the hysteroscopy procedure
Change in Visual Analog Scale (VAS) Pain Score from Baseline to During the Procedure
The outcome will measure the change in pain score using the Visual Analog Scale (VAS) from baseline (immediately before the hysteroscopy) to during the procedure. The VAS score ranging between 0 (no pain) to 10 (worst imaginable pain). Subgroup analyses will be performed by age group, parity, cesarean delivery history, and menopausal status.
Measured: Changes of VAS score of pain from baseline (before procedure) and at 5 minutes of during procedure.
Completed procedure
Successful performance of the intended hysteroscopic procedure. Subgroup analyses will be performed by age group, parity, cesarean delivery history, and menopausal status.
Measured: During the hysteroscopy procedure
Patient satisfaction
Patient-reported satisfaction with the procedure using a validated 5-point Likert scale. Subgroup analyses will be performed by age group, parity, cesarean delivery history, and menopausal status.
Measured: Immediately after the procedure
Adverse effect
Recording any vasovagal symptoms observed or reported, including nausea, bradycardia, or hypotension.
Measured: During and up to 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 posted5 Jan 2026
- Study start1 Feb 2026 (estimated)
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2029 (estimated)
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 Hysteroscopy / MethodsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- YAARA TABIB
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, YAARA TABIB, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07318285
- Sponsor's protocol ID
- 0220-25-HMO
- Acronym
- OPTILID
- Status last verified
- Dec 2025
- First submitted
- 30 Nov 2025
- Last updated
- 5 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD that underlie the results of the primary and secondary outcomes reported in any publication will be shared in anonymized format. Data will include coded patient level information and the data dictionary. Identifiable information will not be shared. Data will be available to qualified researchers upon request following publication of study results.
Publications
Barel O, Preuss E, Stolovitch N, Weinberg S, Barzilay E, Pansky M. Addition of Lidocaine to the Distension Medium in Hysteroscopy Decreases Pain during the Procedure-A Randomized Double-blind, Placebo-controlled Trial. J Minim Invasive Gynecol. 2021 Apr;28(4):865-871. doi: 10.1016/j.jmig.2020.08.003. Epub 2020 Aug 14.
PubMed 32798723Shankar M, Davidson A, Taub N, Habiba M. Randomised comparison of distension media for outpatient hysteroscopy. BJOG. 2004 Jan;111(1):57-62. doi: 10.1046/j.1471-0528.2003.00004.x.
PubMed 14687053Sagiv R, Sadan O, Boaz M, Dishi M, Schechter E, Golan A. A new approach to office hysteroscopy compared with traditional hysteroscopy: a randomized controlled trial. Obstet Gynecol. 2006 Aug;108(2):387-92. doi: 10.1097/01.AOG.0000227750.93984.06.
PubMed 16880310
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Modified Technique of Target Lidocaine Infusion for Pain Control in Office Hysteroscopy: A Double-Blind Randomized Controlled
- ClinicalTrials.gov ID
- NCT07318285
- Acronym / sponsor ID
- OPTILID / 0220-25-HMO
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- YAARA TABIBUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 5 Jan 2026 (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.
The goal of this study is to find out whether a small amount of lidocaine (a common local anesthetic) can reduce pain during office hysteroscopy - a procedure used to look inside the uterus. The study will compare lidocaine to saline (salt water) to see which one helps more with pain relief.
Participants will:
- Receive either lidocaine or saline gently applied inside the cervix right before the procedure
- Undergo the hysteroscopy as planned
- Be asked to rate their pain and satisfaction after the procedure
Lidocaine is commonly and safely used in dental and gynecological procedures. Participation is voluntary, and the procedure itself will not change.
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 |
|---|---|---|
| Control Group | Placebo comparator | Other: Saline (0.9% NaCl)Participants in this arm will receive 5 mL of normal saline infused through the internal cervical os immediately before office hysteroscopy. |
| Lidocaine Group | Experimental | Drug: Lidocaine %2 ampouleParticipants in this arm will receive 5 mL of 2% lidocaine infused through the internal cervical os immediately before office hysteroscopy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 18
- Referred for outpatient diagnostic or operative (see-and-treat) hysteroscopy
- Able and willing to provide written informed consent
Key exclusion criteria (7 listed)
- Pregnancy
- Active pelvic inflammatory disease or cervicitis
- Inability to consent
- Anti-psychotic drugs usage
- Previews cervical surgery (i.e., conization).
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 %2 ampouleA 5 mL dose of 2% lidocaine solution will be infused slowly through the internal os using the hysteroscope before the start of uterine cavity distension. | Drug | Lidocaine Group |
| Saline (0.9% NaCl)A 5 mL dose of sterile normal saline will be infused slowly through the internal os using the same technique as in the intervention arm, immediately before cavity distension. | Other | Control Group |
Primary outcome
Pain During Hysteroscopy Procedure Assessed by Visual Analog Scale (VAS)
Time frame: Immediately during the hysteroscopy procedure
Pain experienced during the procedure, evaluated using a Visual Analog Scale (VAS). The VAS score ranging between 0 (no pain) to 10 (worst imaginable pain). Subgroup analyses will be performed by age group, parity, cesarean delivery history, and menopausal status.
Number of Participants with Successful Access to the Uterine Cavity
Time frame: During the hysteroscopy procedure
The number of participants for whom hysteroscopy successfully reached the uterine cavity, without the need to stop or repeat the procedure. This binary outcome (Yes/No) will be assessed by the performing physician during the procedure. Subgroup analyses will be performed by age group, parity, cesarean delivery history, and menopausal status.
5 secondary outcomes
Visual Analog Scale (VAS) Pain Score 5 Minutes After the Procedure
Time frame: 5 minutes after completion of the hysteroscopy procedure
Change in Visual Analog Scale (VAS) Pain Score from Baseline to During the Procedure
Time frame: Changes of VAS score of pain from baseline (before procedure) and at 5 minutes of during procedure.
Completed procedure
Time frame: During the hysteroscopy procedure
Patient satisfaction
Time frame: Immediately after the procedure
Adverse effect
Time frame: During and up to 10 minutes after the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
- Background: PubMed 32798723Barel O, Preuss E, Stolovitch N, Weinberg S, Barzilay E, Pansky M. Addition of Lidocaine to the Distension Medium in Hysteroscopy Decreases Pain during the Procedure-A Randomized Double-blind, Placebo-controlled Trial. J Minim Invasive Gynecol. 2021 Apr;28(4):865-871. doi: 10.1016/j.jmig.2020.08.003. Epub 2020 Aug 14.
- Background: PubMed 14687053Shankar M, Davidson A, Taub N, Habiba M. Randomised comparison of distension media for outpatient hysteroscopy. BJOG. 2004 Jan;111(1):57-62. doi: 10.1046/j.1471-0528.2003.00004.x.
- Background: PubMed 16880310Sagiv R, Sadan O, Boaz M, Dishi M, Schechter E, Golan A. A new approach to office hysteroscopy compared with traditional hysteroscopy: a randomized controlled trial. Obstet Gynecol. 2006 Aug;108(2):387-92. doi: 10.1097/01.AOG.0000227750.93984.06.
- Individual participant dataSharing planned: Yes. IPD that underlie the results of the primary and secondary outcomes reported in any publication will be shared in anonymized format. Data will include coded patient level information and the data dictionary. Identifiable information will not be shared. Data will be available to qualified researchers upon request following publication of study results.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine %2 ampoule and Saline (0.9% NaCl) in people with Hysteroscopy / Methods and Lidocaine Infusion, run by YAARA TABIB.
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 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: opening soon, as of the sponsor's last update on 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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 During Hysteroscopy Procedure Assessed by Visual Analog Scale (VAS) (time frame: Immediately during the hysteroscopy procedure). 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?
On the ClinicalTrials.gov record for NCT07318285, 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 5 Jan 2026.