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Lidocaine for Pain Control During Intrauterine Device Insertion

NCT ID: NCT03362905

Last Updated: 2017-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

123 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-03

Study Completion Date

2019-01-10

Brief Summary

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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.

Detailed Description

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Conditions

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IUD Insertion Complication

Keywords

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Lidocaine Dosage forms Pain scores

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Lidocaine topical

Intervention Type DRUG

Local anesthetic for reduction of IUD associated pain

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.

Group Type ACTIVE_COMPARATOR

Lidocaine topical

Intervention Type DRUG

Local anesthetic for reduction of IUD associated pain

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.

Group Type ACTIVE_COMPARATOR

Lidocaine topical

Intervention Type DRUG

Local anesthetic for reduction of IUD associated pain

Interventions

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Lidocaine topical

Local anesthetic for reduction of IUD associated pain

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Hadeer Abd-El Shafy Fouad

Resident physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Hadeer Elhagri, M.B.B.Ch

Role: CONTACT

Phone: 01098357256

Email: [email protected]

References

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Aksoy H, Aksoy U, Ozyurt S, Acmaz G, Babayigit M. Lidocaine 10% spray to the cervix reduces pain during intrauterine device insertion: a double-blind randomised controlled trial. J Fam Plann Reprod Health Care. 2016 Apr;42(2):83-7. doi: 10.1136/jfprhc-2014-100917. Epub 2015 Mar 10.

Reference Type BACKGROUND
PMID: 25759418 (View on PubMed)

Buhling KJ, Hauck B, Dermout S, Ardaens K, Marions L. Understanding the barriers and myths limiting the use of intrauterine contraception in nulliparous women: results of a survey of European/Canadian healthcare providers. Eur J Obstet Gynecol Reprod Biol. 2014 Dec;183:146-54. doi: 10.1016/j.ejogrb.2014.10.020. Epub 2014 Oct 30.

Reference Type BACKGROUND
PMID: 25461369 (View on PubMed)

Lopez LM, Bernholc A, Zeng Y, Allen RH, Bartz D, O'Brien PA, Hubacher D. Interventions for pain with intrauterine device insertion. Cochrane Database Syst Rev. 2015 Jul 29;2015(7):CD007373. doi: 10.1002/14651858.CD007373.pub3.

Reference Type BACKGROUND
PMID: 26222246 (View on PubMed)

Gemzell-Danielsson K, Mansour D, Fiala C, Kaunitz AM, Bahamondes L. Management of pain associated with the insertion of intrauterine contraceptives. Hum Reprod Update. 2013 Jul-Aug;19(4):419-27. doi: 10.1093/humupd/dmt022. Epub 2013 May 12.

Reference Type BACKGROUND
PMID: 23670222 (View on PubMed)

Bahamondes L, Mansour D, Fiala C, Kaunitz AM, Gemzell-Danielsson K. Practical advice for avoidance of pain associated with insertion of intrauterine contraceptives. J Fam Plann Reprod Health Care. 2014 Jan;40(1):54-60. doi: 10.1136/jfprhc-2013-100636. Epub 2013 Sep 27.

Reference Type BACKGROUND
PMID: 24076534 (View on PubMed)

Akers AY, Steinway C, Sonalkar S, Perriera LK, Schreiber C, Harding J, Garcia-Espana JF. Reducing Pain During Intrauterine Device Insertion: A Randomized Controlled Trial in Adolescents and Young Women. Obstet Gynecol. 2017 Oct;130(4):795-802. doi: 10.1097/AOG.0000000000002242.

Reference Type BACKGROUND
PMID: 28885425 (View on PubMed)

Tavakolian S, Doulabi MA, Baghban AA, Mortazavi A, Ghorbani M. Lidocaine-Prilocaine Cream as Analgesia for IUD Insertion: A Prospective, Randomized, Controlled, Triple Blinded Study. Glob J Health Sci. 2015 Jan 27;7(4):399-404. doi: 10.5539/gjhs.v7n4p399.

Reference Type BACKGROUND
PMID: 25946948 (View on PubMed)

Golzari SE, Soleimanpour H, Mahmoodpoor A, Safari S, Ala A. Lidocaine and pain management in the emergency department: a review article. Anesth Pain Med. 2014 Feb 15;4(1):e15444. doi: 10.5812/aapm.15444. eCollection 2014 Feb.

Reference Type BACKGROUND
PMID: 24660158 (View on PubMed)

Mody SK, Kiley J, Rademaker A, Gawron L, Stika C, Hammond C. Pain control for intrauterine device insertion: a randomized trial of 1% lidocaine paracervical block. Contraception. 2012 Dec;86(6):704-9. doi: 10.1016/j.contraception.2012.06.004. Epub 2012 Jul 6.

Reference Type BACKGROUND
PMID: 22770792 (View on PubMed)

Other Identifiers

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Lidocaine in IUD pain

Identifier Type: -

Identifier Source: org_study_id