Lidocaine for Pain Control During Intrauterine Device Insertion

Lidocaine for Pain Control During Intrauterine Device Insertion: A Randomized Clinical Trial

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03362905

Enrollment

123

Registered

2017-12-05

Start date

2017-12-03

Completion date

2019-01-10

Last updated

2017-12-05

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

Conditions

IUD Insertion Complication

Keywords

Lidocaine, Dosage forms, Pain scores

Brief summary

Despite being the most common method of contraception, the use of intrauterine devices (IUDs) is limited by the associated pain during insertion. Many pharmacologic interventions had been studied for their efficacy to reduce IUD insertion pain, of them, lidocaine was found to be superior over NSAIDs or other local anesthetics. This work aims at comparing the safety and efficacy of different lidocaine formulations to optimize selection in reduction of IUD associated pain.

Interventions

DRUGLidocaine topical

Local anesthetic for reduction of IUD associated pain

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Intervention model description

This study will include 123 patients who are candidates for IUD contraception. The aim of the study will be explained to all patients and an informed written consent will be taken. After recruitment, patients will be randomized to the 3 study arms using computer generated randomization sheet using MedCalcc version 13 to receive any of: lidocaine spray, cream and injection

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

1. Multiparous women. 2. Over 18 years of age and eligible for IUD insertion. 3. Application of IUD will be done in postmenstrual period.

Exclusion criteria

Null parity. 2. History of failed intrauterine device insertion (uterine perforation, acute expulsion). 3\. Copper allergy. 4. Uterine anomaly. 5. Post-partum endometritis or septic abortion in the past three months. 6. Untreated cervicitis/vaginitis, including bacterial vaginosis. 7. Immunosuppression. 8. History of lidocaine ,prilocaine allergy. 9. Analgesic or anxiolytic use within the last 24 hours before the procedure. 10. Wilson's disease. 11. Suspicion of pregnancy. 12. Untreated abnormal uterine bleeding.

Design outcomes

Primary

Measure	Time frame	Description
Pain scores assessed by 10-point VAS scale	1 year	VAS scores will be assessed on at three different points; baseline after application of speculum and analgesic administration, after grasping cervix with tenaculum, then following hysterometry and IUD insertion.

Secondary

Measure	Time frame	Description
Patient satisfaction to IUD insertion	1 year	Satisfaction will be assessed post-procedure using patient directed survey

Contacts

Primary ContactHadeer Elhagri, M.B.B.Ch

hadeer.elhagri@med.asu.edu.eg01098357256

Outcome results

None listed

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