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

Primary Purpose

Infertility, Female

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
study group
control group
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Infertility, Female focused on measuring intracervical anasthesia , outpatient hystroscopy ,

Eligibility Criteria

undefined - 40 Years (Child, Adult)FemaleAccepts 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.

Sites / Locations

  • Outpatient Hystroscopy of Kasr El Ainy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

study group

control group

Arm 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

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

Outcomes

Primary Outcome Measures

tolerated hystroscopy
complete hystroscopy procedure with tolerable degree of pain.

Secondary Outcome Measures

occurrence of complication
symptoms of vasovagal as vomiting , sweeting and bradycardia

Full Information

First Posted
August 14, 2018
Last Updated
November 18, 2018
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03747692
Brief Title
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

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
August 15, 2018 (Actual)
Primary Completion Date
October 20, 2018 (Actual)
Study Completion Date
October 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: History taking Verbal consent to participate in our study Patient put in lithotomy position Casco speculum was applied exposing the cervix Betadine sterilization of the cervix then properly washed with saline as heavy metals of disinfectant may cause irritation with injection Multiple toothed volselum was used just to fix cervix 3 cartridges of mepivacaine hydrochloride was filled in 10 mi syringe Do aspiration to exclude and avoid intravascular injection then infilterate slowly intracervical at both 3 and 9 positions Instruments are removed and at least 5 minutes later procedure started. Hystroscopy (rigid , 2.9 mm sheath) was introduced gently throw vaginoscopy exploring vagina , cervix and uterine cavity 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 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 All patients were monitored post procedure for persistence of colicky pain

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Female
Keywords
intracervical anasthesia , outpatient hystroscopy ,

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Participant
Masking Description
group 1 will be subjected to intracervical injection of mepicaine hydrochloride 3%iof a local anasthetic as Carbocaine3% and group 2 will be subjected to intracervical injection of 5 ml of normal saline
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
study group
Arm Type
Experimental
Arm 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
Arm Title
control group
Arm Type
Placebo Comparator
Arm 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
Intervention Type
Procedure
Intervention Name(s)
study group
Intervention Description
local anesthesia by mepicaine hydrochloride by intracervical local injection using 10 mm syringe.
Intervention Type
Procedure
Intervention Name(s)
control group
Intervention Description
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.
Primary Outcome Measure Information:
Title
tolerated hystroscopy
Description
complete hystroscopy procedure with tolerable degree of pain.
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
occurrence of complication
Description
symptoms of vasovagal as vomiting , sweeting and bradycardia
Time Frame
30 minutes

10. Eligibility

Sex
Female
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: must be under 40 years must be no history of renal or hepatic disease must be no known hypersensitivity to local anaesthetic agents must be no significant vaginal or cervical infection. Exclusion Criteria: All patients with history of sever vasovagal attack during any gynecological procedures.
Facility Information:
Facility Name
Outpatient Hystroscopy of Kasr El Ainy
City
Giza
ZIP/Postal Code
12521
Country
Egypt

12. IPD Sharing Statement

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

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