The Value of Endocervical and Endometrial Lidocaine Flushing Before Office Hystroscopy

Study Overview
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Brief Summary
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women candidate for office hystroscopy were randomized to either flushing of the endocervix and endometrium with 4 ml lidocaine 2% diluted in 15 ml normal saline or 19 ml normal saline before office hystroscopy

Detailed Description
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Patients were asked to urinate to evacuate the bladder. Posterior vaginal retractor was introduced to expose the cervix and ( embryo transfer catheter was introduced throught the cervix passing the internal os and intrauterine and intracervical instillation of to either flushing of the endocervix and endometrium with 4 ml lidocaine 2% diluted in 15 ml normal saline or 19 ml normal saline. After 5 mins the procedure was started A rigid 3.5 mm hystroscope with an optic of 30 degrees was used. Normal saline solution was used as distension media, with 120 mmHg intrauterine pressure, Vaginoscopic approach, nocervical tenaculum or dilators used. Post procedure pain management by optional dose of 75 mg of diclofenac potassium when requested.

Official Title
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The Value of Endocervical and Endometrial Lidocaine Flushing Before Office Hystroscopy

Conditions
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Pain During Hystroscopy

Intervention / Treatment
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* Drug: Lidocaine
* Procedure: Office hystroscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: all women indicated for office hysteroscopy for evaluation of the uterine cavity eg: AUB, infertility Exclusion Criteria: Women allergic to local anesthesia those required operative hysteroscopy under general anesthesia pelvic inflammatory disease known cervical malignancy profuse uterine bleeding, marked cervical stenosis recent uterine perforation previous cervical surgery and neurological disorders affecting evaluation of pain using other products that could affect the consistency of the cervix such as local estrogen, misoprostol or laminaire are contraindications for office hystroscopy

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lidocaine group<br>intrauterine and intracervical instillation of 4 ml of lidocaine 2% diluted in 15 ml normal saline 5 minutes before hystroscopy | Drug: Lidocaine<br>* intrauterine and intracervical instillation of 4 ml of lidocaine 2% diluted in 15 ml normal saline<br>Procedure: Office hystroscopy<br>* A rigid 3.5 mm hystroscope with an optic of 30 degrees was used. Normal saline solution was used as distension media, with 120 mmHg intrauterine pressure, Vaginoscopic approach, nocervical tenaculum or dilators used.<br>|
| Placebo Comparator: control group<br>intrauterine and intracervical instillation of 19 ml normal saline 5 minutes before hystroscopy | Procedure: Office hystroscopy<br>* A rigid 3.5 mm hystroscope with an optic of 30 degrees was used. Normal saline solution was used as distension media, with 120 mmHg intrauterine pressure, Vaginoscopic approach, nocervical tenaculum or dilators used.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain assessment during the hysteroscopy | pain assessment during hystroscopy using visual analogue scale VAS. is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the no pain anchor and the patient's mark, providing a range of scores from 0-100 | during hystroscopy procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain assessment 10 minutes after hysteroscopy | pain assessment 10 minutes after hystroscopy using visual analogue scale VAS. is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the no pain anchor and the patient's mark, providing a range of scores from 0-100 | 10 minutes after hysteroscopy | 
| Pain assessment 30 minutes after hysteroscopy | pain assessment 30 minutes after hystroscopy using visual analogue scale VAS. is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the no pain anchor and the patient's mark, providing a range of scores from 0-100 | 30 minutes after hysteroscopy | 
| Pain assessment 60 minutes after hysteroscopy | pain assessment 60 minutes after hystroscopy using visual analogue scale VAS. is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the no pain anchor and the patient's mark, providing a range of scores from 0-100 | 60 minutes after hysteroscopy |