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Lidocaine for Pain Control During Intrauterine Device Insertion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03362905
Recruitment Status : Unknown
Verified November 2017 by Hadeer Abd-El Shafy Fouad, Ain Shams University.
Recruitment status was:  Not yet recruiting
First Posted : December 5, 2017
Last Update Posted : December 5, 2017
Sponsor:
Information provided by (Responsible Party):
Hadeer Abd-El Shafy Fouad, Ain Shams University

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.

Condition or disease Intervention/treatment Phase
IUD Insertion Complication Drug: Lidocaine topical Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 123 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Lidocaine for Pain Control During Intrauterine Device Insertion: A Randomized Clinical Trial
Estimated Study Start Date : December 3, 2017
Estimated Primary Completion Date : December 5, 2018
Estimated Study Completion Date : January 10, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Patient satisfaction to IUD insertion [ Time Frame: 1 year ]
    Satisfaction will be assessed post-procedure using patient directed survey



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03362905


Contacts
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Contact: Hadeer Elhagri, M.B.B.Ch 01098357256 hadeer.elhagri@med.asu.edu.eg

Sponsors and Collaborators
Ain Shams University
Publications:

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Responsible Party: Hadeer Abd-El Shafy Fouad, Resident physician, Ain Shams University
ClinicalTrials.gov Identifier: NCT03362905    
Other Study ID Numbers: Lidocaine in IUD pain
First Posted: December 5, 2017    Key Record Dates
Last Update Posted: December 5, 2017
Last Verified: November 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hadeer Abd-El Shafy Fouad, Ain Shams University:
Lidocaine
Dosage forms
Pain scores
Additional relevant MeSH terms:
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Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action