Targeted Lidocaine Infusion for Pain Reduction in Office Hysteroscopy (OPTILID)

YAARA TABIB

Status: Not yet enrolling

Conditions: Hysteroscopy / Methods; Lidocaine Infusion; Placebo - Control

Treatments: Other: Saline (0.9% NaCl); Drug: Lidocaine %2 ampoule

Study type: Interventional

Funder types: Other

Identifiers

NCT07318285

0220-25-HMO

Details and patient eligibility

About

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:

1. Receive either lidocaine or saline gently applied inside the cervix right before the procedure
2. Undergo the hysteroscopy as planned
3. 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.

Enrollment: 208 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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208 participants in 2 patient groups, including a placebo group

Control Group

Placebo Comparator group

Description:

Participants in this arm will receive 5 mL of normal saline infused through the internal cervical os immediately before office hysteroscopy.

Treatment:

Other: Saline (0.9% NaCl)

Lidocaine Group

Experimental group

Description:

Participants in this arm will receive 5 mL of 2% lidocaine infused through the internal cervical os immediately before office hysteroscopy.

Treatment:

Drug: Lidocaine %2 ampoule