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

Not Applicable

Completed

• Conditions: Pain
• Interventions: Drug: Lidocaine Spray; Drug: Placebo

• Registration Number: NCT02039661
• Lead Sponsor: Kayseri Education and Research Hospital

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).

Study Timeline

• Study Start: 2013-11
• Status Verified: 2014-01
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Study First Submitted: 2014-01-16
• Study First Submitted QC: 2014-01-16
• Last Update Submitted: 2014-01-16
• Study First Posted: 2014-01-17
• Last Update Posted: 2014-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

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

Exclusion Criteria

• cervical stenosis myoma uteri pregnancy miscarriage chronic pelvic pain dysmenorrhea

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lidocaine Spray	Lidocaine Spray	-
Placebo	Placebo	These patients received placebo spray.

Primary Outcome Measures

Name	Time	Method
Pain Score	3 months	Patients were asked to rate their pain level on a standard continuous 100-mm VAS to quantify the pain. Pain scoring was 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 were asked to score their pain level experienced during the procedure), and 15 minutes after the procedure.

Trial Locations

Locations (1)

Kayseri Education and Research Hospital of Medicine; 🇹🇷 Kayseri, Turkey