Effect of Lidocaine Spray for Pain Relief During Endometrial Biopsy: a Randomized, Double-blind, Placebo-controlled Clinical Trial

NCT ID: NCT02039661

Last Updated: 2014-01-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2014-01-31

Brief Summary

The effect of lidocaine spray on pain relief during endometrial sampling.

Detailed Description

The study population will comprise women with abnormal uterine bleeding who will be scheduled for endometrial sampling or women who will have control biopsies before surgery due to other pathologies. We have two groups; the first group consisted of patients who receive lidocaine spray. The second group consisted of patients who receive placebo spray. Patients will be asked to rate their pain level on a standard continuous 100-mm VAS to quantify the pain. Pain scoring will be performed at 3 different time points: immediately before to the procedure, during the procedure(immediately following the removal of the speculum from the vagina at the end of the endometrial sampling, the patients will be asked to score their pain level experienced during the procedure), and 15 minutes after the procedure.

We will document the patients' demographics and medical information. All procedures will be performed by a single operator and the same team to avoid possible operator-dependent pain factors (counseling, patient preparation, attitude and operative steps during operation, moral and psychological support).

Conditions

Pain

Study Design

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

Study Groups

Lidocaine Spray

Group Type: ACTIVE_COMPARATOR

Lidocaine Spray

Intervention Type: DRUG

These patients received 2 puff lidocaine spray

Placebo

These patients received placebo spray.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

Lidocaine Spray

These patients received 2 puff lidocaine spray

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age>18 years no allergy Patients with abnormal uterine bleeding

Exclusion Criteria

• cervical stenosis myoma uteri pregnancy miscarriage chronic pelvic pain dysmenorrhea

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Kayseri Education and Research Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Gökhan Açmaz

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gökhan Açmaz, MD

Role: PRINCIPAL_INVESTIGATOR

Kayseri Education and Research Hospital of Medicine

Locations

Kayseri Education and Research Hospital of Medicine

Kayseri, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Gookhan

Identifier Type: -

Identifier Source: org_study_id