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

Pain Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02039661
• Other study ID #: Gookhan
• Status: Completed
• Phase: N/A
• First received: January 16, 2014
• Last updated: January 16, 2014
• Start date: November 2013
• Est. completion date: January 2014

Study information

• Verified date: January 2014
• Source: Kayseri Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Erciyes University Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Lidocaine Spray
These patients received 2 puff lidocaine spray
• Placebo

Locations

Country	Name	City	State
Turkey	Kayseri Education and Research Hospital of Medicine	Kayseri

Sponsors (1)

Lead Sponsor	Collaborator
Kayseri Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Score	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.	3 months	Yes