Clinical trial NCT03747692: Intracervical Anasthesia in Outpatient Hystroscopy, Can Procedure be Completed Diagnostic and Therapeutic With no Need to General Anaesthesia
Official title: Cairo University Faculty of Medicine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility, Female
Keywords: intracervical anasthesia , outpatient hystroscopy ,
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-11-20
Enrollment: 80
Sex: FEMALE
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two groups will be used , 1st study group using intracervical anasthesia of a local anasthetic as Carbocaine3%,and 2nd group using NSAIDs and intracervical injection of a placebo ( saline ).Ask the patient to tell about any sense of nausea or vomiting or drowsiness.
Primary purpose: SUPPORTIVE_CARE

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

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.

Primary outcomes:
measure: tolerated hystroscopy
timeFrame: 30 minutes
Secondary outcomes:
measure: occurrence of complication
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Outpatient Hystroscopy of Kasr El Ainy
Study officials:
References: