The Value of Endocervical and Endometrial Lidocaine Flushing Before Office Hystroscopy
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Cairo University
- Enrollment
- 250
- Locations
- 1
- Primary Endpoint
- Pain assessment during the hysteroscopy
Study Overview
Brief 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
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Lidocaine group
intrauterine and intracervical instillation of 4 ml of lidocaine 2% diluted in 15 ml normal saline 5 minutes before hystroscopy
Intervention: Lidocaine (Drug)
Lidocaine group
intrauterine and intracervical instillation of 4 ml of lidocaine 2% diluted in 15 ml normal saline 5 minutes before hystroscopy
Intervention: Office hystroscopy (Procedure)
control group
intrauterine and intracervical instillation of 19 ml normal saline 5 minutes before hystroscopy
Intervention: Office hystroscopy (Procedure)
Outcomes
Primary Outcomes
Pain assessment during the hysteroscopy
Time Frame: during hystroscopy procedure
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
Secondary Outcomes
- Pain assessment 10 minutes after hysteroscopy(10 minutes after hysteroscopy)
- Pain assessment 30 minutes after hysteroscopy(30 minutes after hysteroscopy)
- Pain assessment 60 minutes after hysteroscopy(60 minutes after hysteroscopy)
Investigators
Ahmed Maged
professor
Cairo University