Lidocaine for Pain Control During Intrauterine Device Insertion

November 30, 2017 updated by: Hadeer Abd-El Shafy Fouad, Ain Shams University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

123

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lidocaine spray Arm
This arm will receive lidocaine spray (Lidocaine topical aerosol ®, 10%, Arab drug co., Egypt) with dose four puffs (50 ml, 10 mg/puff) will be applied to the cervical canal and cervix.
Drug: Lidocaine topical
Local anesthetic for reduction of IUD associated pain
Active Comparator: Lidocaine cream Arm
This arm will receive topical cream (Pridocaine ®, Global Napi, Egypt) with a dose of 2g lidocaine cream will be applied to the cervix via cotton swab.
Drug: Lidocaine topical
Local anesthetic for reduction of IUD associated pain
Active Comparator: Lidocaine injection Arm
This arm will receive lidocaine injection (Debocaine®, 2%, Sigma-Tec, Egypt) with a dose of 80-200 mg equivalent to 10 ml lidocaine (20 mg/ml) is injected at four and eight o'clock of the cervico-vaginal junction, and 2 ml to the area to be grasped with the tenaculum for paracervical block.
Drug: Lidocaine topical
Local anesthetic for reduction of IUD associated pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain scores assessed by 10-point VAS scale
Time Frame: 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.
1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 3, 2017

Primary Completion (Anticipated)

December 5, 2018

Study Completion (Anticipated)

January 10, 2019

Study Registration Dates

First Submitted

November 30, 2017

First Submitted That Met QC Criteria

November 30, 2017

First Posted (Actual)

December 5, 2017

Study Record Updates

Last Update Posted (Actual)

December 5, 2017

Last Update Submitted That Met QC Criteria

November 30, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Lidocaine in IUD pain

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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