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

Kayseri Education and Research Hospital

Status: Completed

Conditions: Pain

Treatments: Drug: Lidocaine Spray; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02039661

Gookhan

Details and patient eligibility

About

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

Full 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).

Enrollment: 120 patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• cervical stenosis myoma uteri pregnancy miscarriage chronic pelvic pain dysmenorrhea

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups, including a placebo group

Lidocaine Spray

Active Comparator group

Treatment:

Drug: Lidocaine Spray

Placebo

Placebo Comparator group

Description:

These patients received placebo spray.

Treatment:

Drug: Placebo