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

NCT03075358 | Completed Phase 3

• 1 other identifier: OBG-2559-04137
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Aspiration pain

  A visual analog scale pain score associated with endometrial aspiration biopsy

  Immediately following endometrial aspiration biopsy

• Postprocedure pain

  A visual analog scale pain score after the procedure

  10 minute after procedure completion

Study Arms (3)

Lidocaine spray

EXPERIMENTAL

Drug: Lidocaine spray

Normal saline spray

SHAM COMPARATOR

Other: Normal saline spray

No spray

NO INTERVENTION

Interventions

Lidocaine spray 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.

Lidocaine spray

Normal saline spray OTHER

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

Normal saline spray

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women undergoing endometrial aspiration biopsy at Maharaj Nakorn Chiang Mai hospital

You may not qualify if:

• 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

Sponsors & Collaborators

• Chiang Mai University: lead

Study Sites (1)

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

Chiang Mai, 50200, Thailand

Location

MeSH Terms

Conditions

Uterine Hemorrhage

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kittipat Charoenkwan, MD, MSc

  Faculty of Medicine, Chiang Mai University

  STUDY CHAIR

• Ratpaporn Piyawetchakarn, MD

  Faculty of Medicine, Chiang Mai University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 6, 2017
• First Posted: March 9, 2017
• Study Start: March 6, 2017
• Primary Completion: January 15, 2018
• Study Completion: January 15, 2018
• Last Updated: March 27, 2018

Record last verified: 2018-03

Locations

TH (1)