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

Cairo University (CU)

Status: Completed

Conditions: Infertility, Female

Treatments: Procedure: study group; Procedure: control group

Study type: Interventional

Funder types: Other

Identifiers

NCT03747692

i18002

Details and patient eligibility

About

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).

Full 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

Enrollment: 80 patients

Sex: Female

Ages: Under 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups, including a placebo group

study group

Experimental group

Description:

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

Treatment:

Procedure: study group

control group

Placebo Comparator group

Description:

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

Treatment:

Procedure: control group