The Value of Endocervical and Endometrial Lidocaine Flushing Before Office Hystroscopy

Cairo University (CU)

Status and phase: Unknown; Phase 4

Conditions: Pain During Hystroscopy

Treatments: Drug: Lidocaine; Procedure: Office hystroscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT03530488

36

Details and patient eligibility

About

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

Full 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.

Enrollment: 250 estimated patients

Sex: Female

Ages: 20 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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250 participants in 2 patient groups, including a placebo group

Lidocaine group

Active Comparator group

Description:

intrauterine and intracervical instillation of 4 ml of lidocaine 2% diluted in 15 ml normal saline 5 minutes before hystroscopy

Treatment:

Procedure: Office hystroscopy

Drug: Lidocaine

control group

Placebo Comparator group

Description:

intrauterine and intracervical instillation of 19 ml normal saline 5 minutes before hystroscopy

Treatment:

Procedure: Office hystroscopy