A Modified Technique of Target Lidocaine Infusion for Pain Control in Office Hysteroscopy: A Double-Blind Randomized Controlled
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 208
- Primary Endpoint
- Pain During Hysteroscopy Procedure Assessed by Visual Analog Scale (VAS)
Study Overview
Brief Summary
The goal of this study is to find out whether a small amount of lidocaine (a common local anesthetic) can reduce pain during office hysteroscopy - a procedure used to look inside the uterus. The study will compare lidocaine to saline (salt water) to see which one helps more with pain relief.
Participants will:
- Receive either lidocaine or saline gently applied inside the cervix right before the procedure
- Undergo the hysteroscopy as planned
- Be asked to rate their pain and satisfaction after the procedure
Lidocaine is commonly and safely used in dental and gynecological procedures. Participation is voluntary, and the procedure itself will not change.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age > 18
- •Referred for outpatient diagnostic or operative (see-and-treat) hysteroscopy
- •Able and willing to provide written informed consent
Exclusion Criteria
- •Pregnancy
- •Active pelvic inflammatory disease or cervicitis
- •Inability to consent
- •Anti-psychotic drugs usage
- •Previews cervical surgery (i.e., conization).
- •Any contraindication for office hysteroscopy- cervical malignancy, profuse uterine bleeding, invisible external os, recent uterine perforation.
- •Known allergy or hypersensitivity to Lidocaine
Arms & Interventions
Control Group
Participants in this arm will receive 5 mL of normal saline infused through the internal cervical os immediately before office hysteroscopy.
Intervention: Saline (0.9% NaCl) (Other)
Lidocaine Group
Participants in this arm will receive 5 mL of 2% lidocaine infused through the internal cervical os immediately before office hysteroscopy.
Intervention: Lidocaine %2 ampoule (Drug)
Outcomes
Primary Outcomes
Pain During Hysteroscopy Procedure Assessed by Visual Analog Scale (VAS)
Time Frame: Immediately during the hysteroscopy procedure
Pain experienced during the procedure, evaluated using a Visual Analog Scale (VAS). The VAS score ranging between 0 (no pain) to 10 (worst imaginable pain). Subgroup analyses will be performed by age group, parity, cesarean delivery history, and menopausal status.
Number of Participants with Successful Access to the Uterine Cavity
Time Frame: During the hysteroscopy procedure
The number of participants for whom hysteroscopy successfully reached the uterine cavity, without the need to stop or repeat the procedure. This binary outcome (Yes/No) will be assessed by the performing physician during the procedure. Subgroup analyses will be performed by age group, parity, cesarean delivery history, and menopausal status.
Secondary Outcomes
- Visual Analog Scale (VAS) Pain Score 5 Minutes After the Procedure(5 minutes after completion of the hysteroscopy procedure)
- Change in Visual Analog Scale (VAS) Pain Score from Baseline to During the Procedure(Changes of VAS score of pain from baseline (before procedure) and at 5 minutes of during procedure.)
- Completed procedure(During the hysteroscopy procedure)
- Patient satisfaction(Immediately after the procedure)
- Adverse effect(During and up to 10 minutes after the procedure)
Investigators
YAARA TABIB
Principal Investigator, Obstetrics and Gynecology Research Unit, Hadassah Medical Center
Hadassah Medical Organization