Transdermal Lidocaine Administration Prior to Insertion Levonorgestrel-releasing Intrauterine System

Clinical Outcomes of Transdermal Lidocaine Administration Prior to Levonorgestrel Releasing Intrauterine System Insertion in Women Delivered Only by Elective Cesarean Section: a Randomized Double Blinded Clinical Trial

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04517890

Enrollment

200

Registered

2020-08-19

Start date

2020-09-01

Completion date

2021-09-01

Last updated

2020-09-21

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

Conditions

IUCD Complication

Brief summary

aims to investigate the effectiveness of Transdermal lidocaine patch for Pain Control During Levonorgestrel Releasing Intrauterine System Insertion in Women Delivered Only by Elective Cesarean Section

Detailed description

Long-acting reversible contraception methods are highly effective methods for reduction of the unplanned pregnancy rate worldwide. The intrauterine device is a single procedure that provides reliable, effective and long term contraception for many women. However, the insertion procedure can be associated with a troublesome degree of pain that prevent some women from choosing its use. Different interventions have been described to decrease pain perception during intrauterine device insertion with no agreement on an effective one.

Interventions

DRUGlidocaine patch

5% lidocaine patch applied at 3 hours before the procedure

DRUGSham patch

Sham patch containing no study medication applied 3 hours before the procedure

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

double blind randomized controlled trial

Intervention model description

double blind randomized controlled trial

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

Inclusion criteria

* Non-pregnant women * Women that did not receive any analgesics or Dinoprostone in the 24 hours prior to insertion * Women who delivered only by cesarean section

Exclusion criteria

* Women with any uterine abnormalities as congenital anomalies, endometrial lesions, adenomyosis, fibroids. * Those with a Category 3 or 4 conditions for intrauterine device insertion according to the WHO Medical Eligibility Criteria for contraceptive use * Allergy to lidocaine * Women refuse to participate in the study

Design outcomes

Primary

Measure	Time frame	Description
The difference in pain scores during intrauterine device insertion	10 minutes	The difference in pain scores during intrauterine device insertion using visual analog scale from 0 to 10

Secondary

Measure	Time frame	Description
duration of IUD insertion	15 minutes	duration of IUD insertion measured in minutes

Countries

Egypt

Contacts

Primary Contacthany f Sallam, md

hany.farouk@aswu.edu.eg+20102435461

Backup Contactnahla w Shady, md

hanygyne@yahoo.com+201022336052

Outcome results

None listed

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