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

NCT ID: NCT03075358

Last Updated: 2018-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-06
• Study Completion Date: 2018-01-15

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.

Conditions

Uterine Bleeding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Lidocaine spray

Group Type: EXPERIMENTAL

Lidocaine spray

Intervention Type: DRUG

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.

Normal saline spray

Group Type: SHAM_COMPARATOR

Normal saline spray

Intervention Type: OTHER

0.8 ml of normal saline spray is applied to the cervix, 3 minutes before starting the procedure

No spray

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

Normal saline spray

0.8 ml of normal saline spray is applied to the cervix, 3 minutes before starting the procedure

Intervention Type: OTHER

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Chiang Mai University

OTHER

Sponsor Role: lead

Responsible Party

Kittipat Charoenkwan, MD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kittipat Charoenkwan, MD, MSc

Role: STUDY_CHAIR

Faculty of Medicine, Chiang Mai University

Ratpaporn Piyawetchakarn, MD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine, Chiang Mai University

Locations

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

Chiang Mai, , Thailand

Countries

Thailand

Other Identifiers

OBG-2559-04137

Identifier Type: -

Identifier Source: org_study_id