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

Chiang Mai University

Status and phase: Completed; Phase 3

Conditions: Uterine Bleeding

Treatments: Drug: Lidocaine spray; Other: Normal saline spray

Study type: Interventional

Funder types: Other

Identifiers

NCT03075358

OBG-2559-04137

Details and patient eligibility

About

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.

Enrollment: 240 patients

Sex: Female

Ages: 20+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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240 participants in 3 patient groups

Lidocaine spray

Experimental group

Treatment:

Drug: Lidocaine spray

Normal saline spray

Sham Comparator group

Treatment:

Other: Normal saline spray

No spray

No Intervention group