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

Primary Purpose

Uterine Bleeding

Status
Completed
Phase
Phase 3
Locations
Thailand
Study Type
Interventional
Intervention
Lidocaine spray
Normal saline spray
Sponsored by
Chiang Mai University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uterine Bleeding

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

No Intervention

Arm Label

Lidocaine spray

Normal saline spray

No spray

Arm Description

Outcomes

Primary Outcome Measures

Aspiration pain
A visual analog scale pain score associated with endometrial aspiration biopsy
Postprocedure pain
A visual analog scale pain score after the procedure

Secondary Outcome Measures

Full Information

First Posted
March 6, 2017
Last Updated
March 23, 2018
Sponsor
Chiang Mai University
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1. Study Identification

Unique Protocol Identification Number
NCT03075358
Brief Title
Effects of Lidocaine Spray for Reducing Pain During Endometrial Aspiration Biopsy : a Randomized Controlled Trial
Official Title
Effects of Lidocaine Spray for Reducing Pain During Endometrial Aspiration Biopsy : a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
March 6, 2017 (Actual)
Primary Completion Date
January 15, 2018 (Actual)
Study Completion Date
January 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chiang Mai University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Bleeding

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lidocaine spray
Arm Type
Experimental
Arm Title
Normal saline spray
Arm Type
Sham Comparator
Arm Title
No spray
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Lidocaine spray
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Normal saline spray
Intervention Description
0.8 ml of normal saline spray is applied to the cervix, 3 minutes before starting the procedure
Primary Outcome Measure Information:
Title
Aspiration pain
Description
A visual analog scale pain score associated with endometrial aspiration biopsy
Time Frame
Immediately following endometrial aspiration biopsy
Title
Postprocedure pain
Description
A visual analog scale pain score after the procedure
Time Frame
10 minute after procedure completion

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kittipat Charoenkwan, MD, MSc
Organizational Affiliation
Faculty of Medicine, Chiang Mai University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ratpaporn Piyawetchakarn, MD
Organizational Affiliation
Faculty of Medicine, Chiang Mai University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of OB-GYN, Faculty of Medicine, Chiang Mai University
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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