The Value of Endocervical and Endometrial Lidocaine Flushing Before Office Hystroscopy

Pain During Hystroscopy Clinical Trial

Official title:

The Value of Endocervical and Endometrial Lidocaine Flushing Before Office Hystroscopy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03530488
• Other study ID #: 36
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: May 2018
• Est. completion date: December 2018

Study information

• Verified date: May 2018
• Source: Cairo University
• Contact: Ahmed Maged, MD
• Phone: +2001005227404
• Email: prof.ahmedmaged[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Flushing
• Pain During Hystroscopy

Intervention

Drug:
• Lidocaine
intrauterine and intracervical instillation of 4 ml of lidocaine 2% diluted in 15 ml normal saline

Procedure:
• Office hystroscopy
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.

Locations

Country	Name	City	State
Egypt	Kasr Alainy medical school	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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