Lidocaine for Pain Control During Intrauterine Device Insertion

IUD Insertion Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03362905
• Other study ID #: Lidocaine in IUD pain
• Status: Not yet recruiting
• Phase: Phase 4
• First received: November 30, 2017
• Last updated: November 30, 2017
• Start date: December 3, 2017
• Est. completion date: January 10, 2019

Study information

• Verified date: November 2017
• Source: Ain Shams University
• Contact: Hadeer Elhagri, M.B.B.Ch
• Phone: 01098357256
• Email: hadeer.elhagri[@]med.asu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 123
• Est. completion date: January 10, 2019
• Est. primary completion date: December 5, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• IUD Insertion Complication

Intervention

Drug:
• Lidocaine topical
Local anesthetic for reduction of IUD associated pain

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

References & Publications (9)

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. — View Citation

Aksoy H, Aksoy Ü, Ozyurt S, Açmaz 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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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;(7):CD007373. doi: 10.1002/14651858.CD007373.pub3. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain scores assessed by 10-point VAS scale	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	Patient satisfaction to IUD insertion	Satisfaction will be assessed post-procedure using patient directed survey	1 year