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

Uterine Bleeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03075358
• Other study ID #: OBG-2559-04137
• Status: Completed
• Phase: Phase 3
• First received: March 6, 2017
• Last updated: March 23, 2018
• Start date: March 6, 2017
• Est. completion date: January 15, 2018

Study information

• Verified date: March 2018
• Source: Chiang Mai University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: January 15, 2018
• Est. primary completion date: January 15, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Uterine Bleeding
• Uterine Hemorrhage

Intervention

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

Locations

Country	Name	City	State
Thailand	Department of OB-GYN, Faculty of Medicine, Chiang Mai University	Chiang Mai

Sponsors (1)

Lead Sponsor	Collaborator
Chiang Mai University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aspiration pain	A visual analog scale pain score associated with endometrial aspiration biopsy	Immediately following endometrial aspiration biopsy
Primary	Postprocedure pain	A visual analog scale pain score after the procedure	10 minute after procedure completion