Effects of Lidocaine Spray for Reducing Pain During Endometrial Aspiration Biopsy : a Randomized Controlled Trial

Endometrial aspiration biopsy has been accepted as a diagnostic procedure of choice for women with abnormal uterine bleeding to examine endometrial pathology. The procedure has high accuracy comparing to conventional fractional curettage. However, it is associated with significant pain during the procedure. In general, there is no specific recommendation regarding the proper anesthesia used during the procedure.

The aim of this study is to examine the effect of lidocaine spray for reducing pain during the endometrial aspiration procedure by comparing it with placebo and no intervention.

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Key information

Conditions

Uterine Bleeding Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Uterine Diseases Uterine Hemorrhage

Age range

20 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Department of OB-GYN, Faculty of Medicine, Chiang Mai University

Chiang Mai, 50200, Thailand

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Women undergoing endometrial aspiration biopsy at Maharaj Nakorn Chiang Mai hospital

Exclusion criteria

Lidocaine allergy
Pregnancy
Previous uterine or cervical surgical procedures
Neurological abnormalities
Coagulopathy
Infection of cervix, vagina, or pelvic cavity
Taking any analgesic drugs within 4 hours before the procedure

Treatment and study plan

Lidocaine spray

Drug

Patients are locally anesthetized with 8 puffs (80 mg, 10mg/puff, 0.8 ml) of 10% lidocaine spray applied thoroughly to the cervix, 3 minutes before starting the procedure.

Normal saline spray

Other

0.8 ml of normal saline spray is applied to the cervix, 3 minutes before starting the procedure

Primary outcomes

Aspiration pain

Time frame: Immediately following endometrial aspiration biopsy

A visual analog scale pain score associated with endometrial aspiration biopsy
Postprocedure pain

Time frame: 10 minute after procedure completion

A visual analog scale pain score after the procedure

Sponsors and collaborators

Lead sponsor

Chiang Mai University

Other

Registry information

Important dates

Study start: 2017
Primary completion: 2018
Study completion: 2018
First posted: Mar 9, 2017
Registry last updated: Mar 27, 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.

Published trials that share one or more normalized conditions with this study.

Completed