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

Infertility, Female Clinical Trial

Official title:

Cairo University Faculty of Medicine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03747692
• Other study ID #: i18002
• Status: Completed
• Phase: N/A
• Start date: August 15, 2018
• Est. completion date: October 30, 2018

Study information

• Verified date: November 2018
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 30, 2018
• Est. primary completion date: October 20, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A to 40 Years

Eligibility

Inclusion Criteria:

1. must be under 40 years

2. must be no history of renal or hepatic disease

3. must be no known hypersensitivity to local anaesthetic agents

4. must be no significant vaginal or cervical infection.

Exclusion Criteria:

• All patients with history of sever vasovagal attack during any gynecological procedures.

Related Conditions & MeSH terms

• Infertility
• Infertility, Female

Intervention

Procedure:
• study group
local anesthesia by mepicaine hydrochloride by intracervical local injection using 10 mm syringe.
• 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.

Locations

Country	Name	City	State
Egypt	Outpatient Hystroscopy of Kasr El Ainy	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	tolerated hystroscopy	complete hystroscopy procedure with tolerable degree of pain.	30 minutes
Secondary	occurrence of complication	symptoms of vasovagal as vomiting , sweeting and bradycardia	30 minutes