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

Cairo University Faculty of Medicine

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).

Study Overview

• Status: Completed
• Conditions: Infertility, Female
• Intervention / Treatment: Procedure: study group; Procedure: control group

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

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt, 12521
    • Outpatient Hystroscopy of Kasr El Ainy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 40 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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	Procedure: study group; local anesthesia by mepicaine hydrochloride by intracervical local injection using 10 mm syringe.
PLACEBO_COMPARATOR: 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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
tolerated hystroscopy	complete hystroscopy procedure with tolerable degree of pain.	30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
occurrence of complication	symptoms of vasovagal as vomiting , sweeting and bradycardia	30 minutes

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 15, 2018
• Primary Completion (ACTUAL): October 20, 2018
• Study Completion (ACTUAL): October 30, 2018

Study Registration Dates

• First Submitted: August 14, 2018
• First Submitted That Met QC Criteria: November 18, 2018
• First Posted (ACTUAL): November 20, 2018

Study Record Updates

• Last Update Posted (ACTUAL): November 20, 2018
• Last Update Submitted That Met QC Criteria: November 18, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: intracervical anasthesia , outpatient hystroscopy ,
• Additional Relevant MeSH Terms: Infertility; Infertility, Female
• Other Study ID Numbers: i18002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No