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Completed

NCT Number: NCT03747692

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

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).

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Key information

Age range

Up to 40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Outpatient Hystroscopy of Kasr El Ainy

Giza, 12521, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

study group

Procedure

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

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.

Primary outcomes

  1. tolerated hystroscopy

    Time frame: 30 minutes

    complete hystroscopy procedure with tolerable degree of pain.

Secondary outcomes

  1. occurrence of complication

    Time frame: 30 minutes

    symptoms of vasovagal as vomiting , sweeting and bradycardia

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Cairo University Faculty of Medicine

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Nov 20, 2018
Registry last updated
Nov 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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