Uterine Bleeding
Conditions
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.
Interventions
DRUGLidocaine 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.
OTHERNormal saline spray
0.8 ml of normal saline spray is applied to the cervix, 3 minutes before starting the procedure
Sponsors
Chiang Mai University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Aspiration pain | Immediately following endometrial aspiration biopsy | A visual analog scale pain score associated with endometrial aspiration biopsy |
| Postprocedure pain | 10 minute after procedure completion | A visual analog scale pain score after the procedure |
Countries
Thailand
Outcome results
None listed