Lidocaine In-situ Gel Before Intrauterine Device Insertion

Effect of Self-administered Lidocaine In-situ Gel on Intrauterine Device Insertion Pain: A Randomized Controlled Trial

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02943135

Enrollment

120

Registered

2016-10-24

Start date

2017-10-01

Completion date

2020-03-30

Last updated

2020-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain Relief

Brief summary

Intrauterine device can cause pain and discomfort in several ways: Use of the tenaculum to grasp the cervix and straighten the uterus for proper insertion; trans-cervical actions including measuring uterine depth, inserting the insertion tube, and removing the tube; and placement of the device in the uterus.

Interventions

DRUGlidocaine in-situ gel

lidocaine in-situ gel

DRUGplacebo in-situ gel

placebo in-situ gel

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 50 Years

Healthy volunteers

Inclusion criteria

* Women not taken analgesics or anxiolytics in the 24 hours prior insertion * Women not taken misoprostol prior to insertion * No contraindication to or history of allergic reaction to lidocaine * Women who will accept to participate in the study

Exclusion criteria

* Lidocaine allergy * Any contraindication to device placement

Design outcomes

Primary

Measure	Time frame
Mean pain score during intrauterine device insertion	30 min

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026