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

NCT ID: NCT03747692

Last Updated: 2018-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-15
• Study Completion Date: 2018-10-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

study group

patient put in dorsal postion , insertion of a speculum , sterilization of the cervix then intracervical injection of 5 ml mepicaine hydrochloride a local anasthetic as Carbocaine3%54 mg at site 3 and 9 using a 10 cm syringe

Group Type: EXPERIMENTAL

study group

Intervention Type: PROCEDURE

local anesthesia by mepicaine hydrochloride by intracervical local injection using 10 mm syringe.

control group

patient receives one tablet of NSAIDs (diclofenac sodium 50 mg )15 minutes before procedure then 5 ml of normal saline will be injected intracervical using 10 cm syringe then wait for 5 minutes before the procedure

Group Type: PLACEBO_COMPARATOR

control group

Intervention Type: PROCEDURE

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.

Interventions

study group

local anesthesia by mepicaine hydrochloride by intracervical local injection using 10 mm syringe.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Olfat Nooh Riad Ali

professor in cairo univerity

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Outpatient Hystroscopy of Kasr El Ainy

Giza, , Egypt

Countries

Egypt

Other Identifiers

i18002

Identifier Type: -

Identifier Source: org_study_id