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

NCT03747692 | Completed

• 1 other identifier: i18002
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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).

Conditions

Infertility, Female

Keywords

intracervical anasthesia , outpatient hystroscopy ,

Outcome Measures

Primary Outcomes (1)

• tolerated hystroscopy

  complete hystroscopy procedure with tolerable degree of pain.

  30 minutes

Secondary Outcomes (1)

• occurrence of complication

  30 minutes

Study Arms (2)

study group

EXPERIMENTAL

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

control group

PLACEBO COMPARATOR

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

Interventions

study group PROCEDURE

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

study group

control group 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.

control group

Eligibility Criteria

• Age: Up to 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• All patients with history of sever vasovagal attack during any gynecological procedures.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Outpatient Hystroscopy of Kasr El Ainy

Giza, 12521, Egypt

Location

MeSH Terms

Conditions

Infertility, Female

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor in cairo univerity

Model Details: 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.

Study Record Dates

• First Submitted: August 14, 2018
• First Posted: November 20, 2018
• Study Start: August 15, 2018
• Primary Completion: October 20, 2018
• Study Completion: October 30, 2018
• Last Updated: November 20, 2018

Record last verified: 2018-11

Locations

EG (1)