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

Sponsor
Chiang Mai University (Other)
Overall Status
Completed
CT.gov ID
NCT03075358
Collaborator
(none)
240
Enrollment
1
Location
3
Arms
10.3
Actual Duration (Months)
23.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Lidocaine spray
  • Other: Normal saline spray
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
240 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Effects of Lidocaine Spray for Reducing Pain During Endometrial Aspiration Biopsy : a Randomized Controlled Trial
Actual Study Start Date :
Mar 6, 2017
Actual Primary Completion Date :
Jan 15, 2018
Actual Study Completion Date :
Jan 15, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Lidocaine spray

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.
Sham Comparator: Normal saline spray

Other: Normal saline spray
0.8 ml of normal saline spray is applied to the cervix, 3 minutes before starting the procedure
No Intervention: No spray

Outcome Measures

Primary Outcome Measures

  1. Aspiration pain [Immediately following endometrial aspiration biopsy]

    A visual analog scale pain score associated with endometrial aspiration biopsy

  2. Postprocedure pain [10 minute after procedure completion]

    A visual analog scale pain score after the procedure

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of OB-GYN, Faculty of Medicine, Chiang Mai University Chiang Mai Thailand 50200

Sponsors and Collaborators

  • Chiang Mai University

Investigators

  • Study Chair: Kittipat Charoenkwan, MD, MSc, Faculty of Medicine, Chiang Mai University
  • Principal Investigator: Ratpaporn Piyawetchakarn, MD, Faculty of Medicine, Chiang Mai University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kittipat Charoenkwan, MD, Associate Professor, Chiang Mai University
ClinicalTrials.gov Identifier:
NCT03075358
Other Study ID Numbers:
  • OBG-2559-04137
First Posted:
Mar 9, 2017
Last Update Posted:
Mar 27, 2018
Last Verified:
Mar 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
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
Additional relevant MeSH terms:
Uterine Hemorrhage
Lidocaine

Study Results

No Results Posted as of Mar 27, 2018