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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:
Lidocaine is commonly and safely used in dental and gynecological procedures. Participation is voluntary, and the procedure itself will not change.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Lidocaine Group | Experimental | Participants in this arm will receive 5 mL of 2% lidocaine infused through the internal cervical os immediately before office hysteroscopy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine %2 ampoule | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | During the hysteroscopy procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 5 minutes after completion of the hysteroscopy procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32798723 | Background | 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. | |
| 14687053 |
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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.
Data will be available starting 6 months after publication and for a period of 5 years
Access will be granted to researchers with approved scientific proposals. Requests will be reviewed by the principal investigator and institutional review board. Data will be shared through secure institutional channels.
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| 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. |
|
| 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. | 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. | 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. | Immediately after the procedure |
| Adverse effect | Recording any vasovagal symptoms observed or reported, including nausea, bradycardia, or hypotension. | During and up to 10 minutes after the procedure |
| Shankar 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. |
| 16880310 | Background | Sagiv 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. |
| D017670 |
| Sodium Compounds |