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

NCT03075358 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2018-03-27

No results posted yet for this study

Summary

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.

Conditions

  • Uterine Bleeding

Interventions

DRUG

Lidocaine spray

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.

OTHER

Normal saline spray

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

Sponsors & Collaborators

  • Chiang Mai University

    lead OTHER

Principal Investigators

  • Kittipat Charoenkwan, MD, MSc · Faculty of Medicine, Chiang Mai University

  • Ratpaporn Piyawetchakarn, MD · Faculty of Medicine, Chiang Mai University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-06
Primary Completion
2018-01-15
Completion
2018-01-15

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03075358 on ClinicalTrials.gov