NCT03747692

Intracervical Anasthesia in Outpatient Hystroscopy, Can Procedure be Completed Diagnostic and Therapeutic With no Need to General Anaesthesia

Cairo University Faculty of Medicine

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Cairo University · Academic / Other
• Sex: Female
• Age: 40 Years
• Healthy volunteers: Accepted

Summary

Single blind randomized controlled study in which 80 patients coming for hystroscopy due to multiple indication as infertility, AUB and missed IUD were assigned for our study. Both Sample size and randomization were done by a computer program. Patients were classified into 2 groups, group 1 study group was subjected to intracervical injection of 5 mi of mepivacaine hydrochloride at position 3 and 9 of the vaginal portion of the cervix, and at least 5 minutes post injection before procedure done. The control group received NSAI injection 15 minutes before procedure and 5 ml of saline was injected in each side of cervix at 3 9 positions. Hystroscopy was done if an abnormality is detected an intervention was done. A descriptive scale of pain was done into mild, moderate or severe (that lead to interruption of the procedures).

Detailed description

Procedures: All patients were subjected to: 1. History taking 2. Verbal consent to participate in our study 3. Patient put in lithotomy position 4. Casco speculum was applied exposing the cervix 5. Betadine sterilization of the cervix then properly washed with saline as heavy metals of disinfectant may cause irritation with injection 6. Multiple toothed volselum was used just to fix cervix 7. 3 cartridges of mepivacaine hydrochloride was filled in 10 mi syringe 8. Do aspiration to exclude and avoid intravascular injection then infilterate slowly intracervical at both 3 and 9 positions 9. Instruments are removed and at least 5 minutes later procedure started. 10. Hystroscopy (rigid , 2.9 mm sheath) was introduced gently throw vaginoscopy exploring vagina , cervix and uterine cavity 11. Patient was monitored for pain all through the procedure by descriptive scale, mild, moderate and severe. ( moderate who needed to take rest then continue , severe that necessitated interruption of the procedure 12. All patients were monitored for signs of vaso vagal attack as sings (low blood pressure and bradycardia) before and if needed during. Occurrence of symptoms as pallor , sweet and fainting 13. All patients were monitored post procedure for persistence of colicky pain

Conditions

• Infertility, Female

Interventions

Type	Name	Description
PROCEDURE	study group	local anesthesia by mepicaine hydrochloride by intracervical local injection using 10 mm syringe.
PROCEDURE	control group	each patient receives one tablet of NSAIDs (diclofenac sodium 50 mg) and 5ml of a placebo in form of normal saline are injected intracervical 5 minutes before the procedure using 10 mm syringe.

Timeline

• Start date: 2018-08-15
• Primary completion: 2018-10-20
• Completion: 2018-10-30
• First posted: 2018-11-20
• Last updated: 2018-11-20

Locations

1 site across 1 country: Egypt