Endocervical Lidocaine Spray for Pain Control During Office Hysteroscopy

Endocervical Lidocaine Spray for Pain Control During Office Hysteroscopy - a Randomized Control Trial.

lidocaine spray is used endocervical before office hysteroscopy to reduce the pain

Study Overview

• Status: Unknown
• Conditions: Pain Uterus
• Intervention / Treatment: Drug: Endocervical Lidocaine spray

Detailed Description

5 sprays of Lidocaine is applied 3 minutes before office hysteroscopy

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11562
    • Recruiting
    • Kasr El Ainiy Hospital
  • Cairo, Egypt
    • Recruiting
    • Kasr Alaini Hospital
    • Sub-Investigator: Wafaa R Desouky, MD
    • Sub-Investigator: Amira M Yehia, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

Patients indicated for diagnostic hysteroscopy for infertility or AUB. Postmenstrual between days 7 and 11 of the cycle ( except in irregular bleeding)

Exclusion Criteria:

Contraindication to office hysteroscopy Neurological disorders affecting the evaluation of pain. Previous cervical surgery.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A (Lidocaine group); 5 sprays of endocervical Lidocaine 10% spray ( AstraZeneca, bedforshire) are used 3 minutes before office hysteroscopy	Drug: Endocervical Lidocaine spray; 5 sprays of endocervical Lidocaine spray (10%) is used 3 minutes before office hysteroscopy
No Intervention: Group B (control group); office hysteroscopy is done without analgesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain sensation	The level of pelvic pain will be rated according to a 10-point visual analogue scale (VAS)	The VAS will be applied immediately after the procedure ended
Procedure time	from introduction of the office hysteroscopy through the external cervical os and the visualization of the uterine cavity	immediately after the process

Collaborators and Investigators

• Sponsor: Kasr El Aini Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2017
• Primary Completion (Anticipated): March 1, 2018
• Study Completion (Anticipated): March 1, 2018

Study Registration Dates

• First Submitted: December 19, 2017
• First Submitted That Met QC Criteria: December 19, 2017
• First Posted (Actual): December 26, 2017

Study Record Updates

• Last Update Posted (Actual): January 24, 2018
• Last Update Submitted That Met QC Criteria: January 23, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: office hysteroscopy; Lidocaine spray
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: 171217

Drug and device information, study documents

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